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- Page 3

# FDAPulse: all 764 record reports, page 3 of 4

Every FDAPulse record report, 200 per page, grouped by state. Records 401 to 600: Class II recall Z-0169-2027: Medline Industries, LP to Class III recall Z-0109-2027: Mindray DS USA, Inc.. Source: U.S. FDA openFDA.

[1](/hub/fdapulse/records) [2](/hub/fdapulse/records/2) 3 [4](/hub/fdapulse/records/4)

## Illinois

- [Class II recall Z-0169-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0169-2027-il--z-0169-2027)
- [Class II recall Z-0170-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0170-2027-il--z-0170-2027)
- [Class II recall Z-0171-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0171-2027-il--z-0171-2027)
- [Class II recall Z-0172-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0172-2027-il--z-0172-2027)
- [Class II recall Z-0173-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0173-2027-il--z-0173-2027)
- [Class II recall Z-0174-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0174-2027-il--z-0174-2027)
- [Class II recall Z-0175-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0175-2027-il--z-0175-2027)
- [Class II recall Z-0176-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0176-2027-il--z-0176-2027)
- [Class II recall Z-0177-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0177-2027-il--z-0177-2027)
- [Class II recall Z-0178-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0178-2027-il--z-0178-2027)
- [Class II recall Z-0179-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0179-2027-il--z-0179-2027)
- [Class II recall Z-0180-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0180-2027-il--z-0180-2027)
- [Class II recall Z-0181-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0181-2027-il--z-0181-2027)
- [Class II recall Z-0182-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0182-2027-il--z-0182-2027)
- [Class II recall Z-0183-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0183-2027-il--z-0183-2027)
- [Class II recall Z-0184-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0184-2027-il--z-0184-2027)
- [Class II recall Z-0185-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0185-2027-il--z-0185-2027)
- [Class II recall Z-0189-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0189-2027-il--z-0189-2027)
- [Class II recall Z-0269-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0269-2027-il--z-0269-2027)
- [Class II recall Z-0270-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0270-2027-il--z-0270-2027)
- [Class II recall Z-0271-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0271-2027-il--z-0271-2027)
- [Class II recall Z-0272-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0272-2027-il--z-0272-2027)
- [Class II recall Z-0273-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0273-2027-il--z-0273-2027)
- [Class II recall Z-0274-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0274-2027-il--z-0274-2027)
- [Class II recall Z-0275-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0275-2027-il--z-0275-2027)
- [Class II recall Z-0276-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0276-2027-il--z-0276-2027)
- [Class II recall Z-0277-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0277-2027-il--z-0277-2027)
- [Class II recall Z-0278-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0278-2027-il--z-0278-2027)
- [Class II recall Z-0279-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0279-2027-il--z-0279-2027)
- [Class II recall Z-0280-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0280-2027-il--z-0280-2027)
- [Class II recall Z-0281-2027: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-0281-2027-il--z-0281-2027)
- [Class II recall Z-3229-2026: Medline Industries, LP](/report/fdapulse/class-ii-recall-z-3229-2026-il--z-3229-2026)
- [Class II recall Z-3295-2026: Cardinal Health 200, LLC](/report/fdapulse/class-ii-recall-z-3295-2026-il--z-3295-2026)
- [Class II recall Z-3296-2026: Cardinal Health 200, LLC](/report/fdapulse/class-ii-recall-z-3296-2026-il--z-3296-2026)
- [Class II recall Z-3297-2026: Cardinal Health 200, LLC](/report/fdapulse/class-ii-recall-z-3297-2026-il--z-3297-2026)
- [Class II recall Z-3298-2026: Cardinal Health 200, LLC](/report/fdapulse/class-ii-recall-z-3298-2026-il--z-3298-2026)
- [Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLC](/report/fdapulse/ecomed-disposable-administration-sets-k254123-il--k254123)
- [Elecsys HBsAg II quant II RxDx (DEN260027): 510(k) cleared for Roche Diagnostics](/report/fdapulse/elecsys-hbsag-ii-quant-ii-rxdx-den260027-il--den260027)
- [Embrace Vision Neonatal MRI System (K261758): 510(k) cleared for Aspect Imaging, Ltd.](/report/fdapulse/embrace-vision-neonatal-mri-system-k261758-il--k261758)
- [Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd.](/report/fdapulse/hyperdrive-35-guidewire-k253146-il--k253146)
- [LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc.](/report/fdapulse/luxdesign-k260421-il--k260421)
- [MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd.](/report/fdapulse/mecare-alpha-mca2019-k260426-il--k260426)
- [MultiNeO Dental Implant System (K261295): 510(k) cleared for Alpha Bio Tec , Ltd.](/report/fdapulse/multineo-dental-implant-system-k261295-il--k261295)
- [NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU Medical](/report/fdapulse/normoflo-irrigation-fluid-warming-sets-and-accessories-ir-il--k262532)
- [SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd.](/report/fdapulse/smartipl-ni-system-k241973-il--k241973)
- [Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set (K260857): 510(k) cleared for Sol-Millennium Medical, Inc.](/report/fdapulse/sol-guard-safety-pull-button-collection-set-sol-guard-il--k260857)
- [Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.](/report/fdapulse/tempus-ecg-mr-k254297-il--k254297)
- [TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc.](/report/fdapulse/tumorsight-risk-k260023-il--k260023)

## Indiana

- [Class II recall Z-0163-2027: Cook Incorporated](/report/fdapulse/class-ii-recall-z-0163-2027-in--z-0163-2027)
- [Class II recall Z-0201-2027: Beckman Coulter, Inc.](/report/fdapulse/class-ii-recall-z-0201-2027-in--z-0201-2027)
- [Class II recall Z-0202-2027: Beckman Coulter, Inc.](/report/fdapulse/class-ii-recall-z-0202-2027-in--z-0202-2027)
- [Duet™ Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC](/report/fdapulse/duet-spinal-fixation-system-k262712-in--k262712)
- [Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics](/report/fdapulse/elecsys-ebv-ebna-igg-k260221-in--k260221)
- [Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics](/report/fdapulse/elecsys-ebv-igm-k260233-in--k260233)
- [Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics](/report/fdapulse/elecsys-ebv-vca-igg-k260232-in--k260232)
- [G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet](/report/fdapulse/g7-acetabular-system-k261453-in--k261453)
- [Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd.](/report/fdapulse/kentrospine-viktr-mis-pedicle-screw-system-k252139-in--k252139)
- [OsseoFit Stemless Shoulder System (K262955): 510(k) cleared for Zimmer, Inc.](/report/fdapulse/osseofit-stemless-shoulder-system-k262955-in--k262955)
- [Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp.](/report/fdapulse/pediatric-nailing-platform-femur-k261345-in--k261345)
- [Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin](/report/fdapulse/polymed-tur-irrigation-set-single-spike-tubing-90-with-luer-in--k261670)
- [qCT Lung (v1.0) (K261517): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd.](/report/fdapulse/qct-lung-v1-0-k261517-in--k261517)

## Iowa

- [Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.](/report/fdapulse/align-cover-and-pad-guidance-tool-k260114-ia--k260114)
- [MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.](/report/fdapulse/modo-duo-electric-pump-b11621-b11673-k261782-ia--k261782)

## IT

- [Digistat Care (K261287): 510(k) cleared for Ascom Ums Srl Unipersonale](/report/fdapulse/digistat-care-k261287-it--k261287)
- [Dual Stage Venous Cannulae (K263092): 510(k) cleared for Sorin Group Italia S.R.L.](/report/fdapulse/dual-stage-venous-cannulae-k263092-it--k263092)
- [HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L](/report/fdapulse/horizon-8af-integrated-oxy-module-8af-and-horizon-cvr-it--k261438)
- [Plenity-V (MC0979 / GS110) (K261783): 510(k) cleared for Gelesis SRL](/report/fdapulse/plenity-v-mc0979-gs110-k261783-it--k261783)
- [Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L.](/report/fdapulse/tri-stage-venous-cannulae-k262052-it--k262052)
- [Vessel Closure Device (VCD177213P) (K260677): 510(k) cleared for Vcd Medical S.R.L.](/report/fdapulse/vessel-closure-device-vcd177213p-k260677-it--k260677)

## JP

- [APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation](/report/fdapulse/aperto-lucent-mri-system-k261283-jp--k261283)
- [CuratOR EX2742 (K262397): 510(k) cleared for Eizo Corporation](/report/fdapulse/curator-ex2742-k262397-jp--k262397)
- [DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd.](/report/fdapulse/diamed-handpiece-diamed-airmotor-diamed-airmotor-handpiece-jp--k262144)
- [ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation](/report/fdapulse/echelon-synergy-k262902-jp--k262902)
- [KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory](/report/fdapulse/kowa-fm-600-k261255-jp--k261255)
- [Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd.](/report/fdapulse/lilium-one-usm330-k260605-jp--k260605)
- [Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd.](/report/fdapulse/miru-1day-upside-midafilcon-a-k262495-jp--k262495)
- [SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation](/report/fdapulse/scenaria-view-phase-6-0-k261229-jp--k261229)
- [SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation](/report/fdapulse/slit-lamp-sl-d4-type-jp--k262637)
- [TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan](/report/fdapulse/tsk-optixion-k262516-jp--k262516)

## Kansas

- [Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System (K261607): 510(k) cleared for Spinal Simplici](/report/fdapulse/minuteman-g6-mis-fusion-plate-minuteman-g5-mis-fusion-plate-ks--k261607)

## KR

- [Amber Arte (K262523): 510(k) cleared for Hass Corp.](/report/fdapulse/amber-arte-k262523-kr--k262523)
- [AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd.](/report/fdapulse/anyplus-ii-spinal-fixation-system-k261217-kr--k261217)
- [AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.](/report/fdapulse/aview-aorta-metrics-k260391-kr--k260391)
- [cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc.](/report/fdapulse/ccell-in-vivo-k260315-kr--k260315)
- [cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.](/report/fdapulse/ccell405-k254030-kr--k254030)
- [Cemented Plus Abutment (K262207): 510(k) cleared for Unidental Co., Ltd.](/report/fdapulse/cemented-plus-abutment-k262207-kr--k262207)
- [Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd.](/report/fdapulse/core-it-dual-k262982-kr--k262982)
- [CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc.](/report/fdapulse/cvs-advanced-plus-blood-glucose-monitoring-system-k260689-kr--k260689)
- [Dia-X Sil Heavy Body (K254142): 510(k) cleared for DiaDent Group International](/report/fdapulse/dia-x-sil-heavy-body-k254142-kr--k254142)
- [Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International](/report/fdapulse/dia-x-sil-light-body-k254152-kr--k254152)
- [Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc.](/report/fdapulse/dr-alignnavi-k262378-kr--k262378)
- [ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.](/report/fdapulse/ecg-analysis-software-aitialvsd-k254302-kr--k254302)
- [EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd.](/report/fdapulse/estemp-implant-k262983-kr--k262983)
- [EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound](/report/fdapulse/evo-x30-diagnostic-ultrasound-system-evo-x20-diagnostic-kr--k263182)
- [INNI-CERA (BCM-W500, BCM-W1000) (K262980): 510(k) cleared for DentMedi Co., Ltd.](/report/fdapulse/inni-cera-bcm-w500-bcm-w1000-k262980-kr--k262980)
- [Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc](/report/fdapulse/medical-monitor-32md08wc-k262985-kr--k262985)
- [MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation](/report/fdapulse/mint-mono-sutures-k254238-kr--k254238)
- [NeckTune™ SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd.](/report/fdapulse/necktune-sa-cervical-cage-k262726-kr--k262726)
- [NEXT-Cue (K261805): 510(k) cleared for Neuroxt, Inc.](/report/fdapulse/next-cue-k261805-kr--k261805)
- [NOVIX Pedicle Screw System (K263062): 510(k) cleared for Tdm Co., Ltd.](/report/fdapulse/novix-pedicle-screw-system-k263062-kr--k263062)
- [Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd.](/report/fdapulse/odys-si-screw-k262522-kr--k262522)
- [OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd.](/report/fdapulse/orthofit-aligner-orthofit-aligner-a2-k262433-kr--k262433)
- [Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd.](/report/fdapulse/park-s-pectus-system-k263269-kr--k263269)
- [PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.](/report/fdapulse/picoremax-picoremax-k254199-kr--k254199)
- [Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated](/report/fdapulse/potenza-prime-k254185-kr--k254185)
- [REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210): 510(k) cleared for Hyundai Bioland Co., Ltd.](/report/fdapulse/rebohil-bgm-1-bgm-2-bgm-3-bgm-4-bgm-5-k254210-kr--k254210)
- [REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc.](/report/fdapulse/remex-t-k-100c-k261943-kr--k261943)
- [S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.](/report/fdapulse/s-patch-cardioai-k254255-kr--k254255)
- [SwiftSight-BodyComposition (K261612): 510(k) cleared for Airs Medical, Inc.](/report/fdapulse/swiftsight-bodycomposition-k261612-kr--k261612)
- [TDM Large Bone Plate and Screw System (K261611): 510(k) cleared for Tdm Co., Ltd.](/report/fdapulse/tdm-large-bone-plate-and-screw-system-k261611-kr--k261611)
- [The VEGA Cervical Screw System (K254260): 510(k) cleared for GS Medical Co., Ltd.](/report/fdapulse/the-vega-cervical-screw-system-k254260-kr--k254260)
- [V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Dia](/report/fdapulse/v10-diagnostic-ultrasound-system-cv10-diagnostic-ultrasound-kr--k263150)

## LT

- [Ligence Heart (K261733): 510(k) cleared for UAB Ligence](/report/fdapulse/ligence-heart-k261733-lt--k261733)

## LU

- [SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A.](/report/fdapulse/spinesim-v1-0-k261861-lu--k261861)

## Maine

- [Class II recall Z-0268-2027: Solstice Corporation](/report/fdapulse/class-ii-recall-z-0268-2027-me--z-0268-2027)
- [SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc.](/report/fdapulse/spotfire-vg-control-panel-m534-spotfire-vg-negative-control-me--k262573)

## Maryland

- [BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163): 510(k) cleared for Becton Dickinson and Company](/report/fdapulse/bd-bbl-mueller-hinton-ii-broth-cation-adjusted-bd-difco-md--k262163)
- [Class II recall Z-0139-2027: Becton Dickinson & Co.](/report/fdapulse/class-ii-recall-z-0139-2027-md--z-0139-2027)
- [Class II recall Z-0140-2027: Becton Dickinson & Co.](/report/fdapulse/class-ii-recall-z-0140-2027-md--z-0140-2027)
- [CraniUS Plate (K262874): 510(k) cleared for CraniUS, LLC](/report/fdapulse/cranius-plate-k262874-md--k262874)
- [Oncomine ™ Dx Express Test (K260827): 510(k) cleared for Life Technologies Corporation](/report/fdapulse/oncomine-dx-express-test-k260827-md--k260827)

## Massachusetts

- [a2z-Abdo-Triage (K260906): 510(k) cleared for A2z Radiology Ai, Inc.](/report/fdapulse/a2z-abdo-triage-k260906-ma--k260906)
- [BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp.](/report/fdapulse/bodytom-64-nl4100-omnitom-elite-nl5000-k261125-ma--k261125)
- [BTL-299-F (K262353): 510(k) cleared for BTL Industries, Inc.](/report/fdapulse/btl-299-f-k262353-ma--k262353)
- [Class I recall Z-0001-2027: Instrumentation Laboratory](/report/fdapulse/class-i-recall-z-0001-2027-ma--z-0001-2027)
- [Class I recall Z-0002-2027: Instrumentation Laboratory](/report/fdapulse/class-i-recall-z-0002-2027-ma--z-0002-2027)
- [Class II recall Z-0078-2027: PHILIPS MEDICAL SYSTEMS](/report/fdapulse/class-ii-recall-z-0078-2027-ma--z-0078-2027)
- [Class II recall Z-0117-2027: LeMaitre Vascular, Inc.](/report/fdapulse/class-ii-recall-z-0117-2027-ma--z-0117-2027)
- [Class II recall Z-0143-2027: Boston Scientific Corporation](/report/fdapulse/class-ii-recall-z-0143-2027-ma--z-0143-2027)
- [Class II recall Z-0199-2027: Philips North America](/report/fdapulse/class-ii-recall-z-0199-2027-ma--z-0199-2027)
- [Class II recall Z-3155-2026: Philips North America Llc](/report/fdapulse/class-ii-recall-z-3155-2026-ma--z-3155-2026)
- [Class II recall Z-3225-2026: Fresenius Medical Care Renal Therapies Group, LLC](/report/fdapulse/class-ii-recall-z-3225-2026-ma--z-3225-2026)
- [Class II recall Z-3233-2026: Philips North America Llc](/report/fdapulse/class-ii-recall-z-3233-2026-ma--z-3233-2026)
- [Class II recall Z-3239-2026: Philips North America Llc](/report/fdapulse/class-ii-recall-z-3239-2026-ma--z-3239-2026)
- [Class II recall Z-3242-2026: Philips North America Llc](/report/fdapulse/class-ii-recall-z-3242-2026-ma--z-3242-2026)
- [Class II recall Z-3251-2026: Abiomed, Inc.](/report/fdapulse/class-ii-recall-z-3251-2026-ma--z-3251-2026)
- [Class II recall Z-3307-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3307-2026-ma--z-3307-2026)
- [Class II recall Z-3308-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3308-2026-ma--z-3308-2026)
- [Class II recall Z-3309-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3309-2026-ma--z-3309-2026)
- [Class II recall Z-3310-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3310-2026-ma--z-3310-2026)
- [Class II recall Z-3311-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3311-2026-ma--z-3311-2026)
- [Class II recall Z-3312-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3312-2026-ma--z-3312-2026)
- [Class II recall Z-3313-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3313-2026-ma--z-3313-2026)
- [Class II recall Z-3314-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3314-2026-ma--z-3314-2026)
- [Class II recall Z-3315-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3315-2026-ma--z-3315-2026)
- [Class II recall Z-3316-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3316-2026-ma--z-3316-2026)
- [Class II recall Z-3317-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3317-2026-ma--z-3317-2026)
- [Class II recall Z-3318-2026: Philips North America](/report/fdapulse/class-ii-recall-z-3318-2026-ma--z-3318-2026)
- [Class III recall Z-0162-2027: Magellan Diagnostics, Inc.](/report/fdapulse/class-iii-recall-z-0162-2027-ma--z-0162-2027)
- [Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc.](/report/fdapulse/elucid-ffr-iq-b-1-k262015-ma--k262015)
- [Elucid PlaqueIQ (K261855): 510(k) cleared for Elucid Bioimaging, Inc.](/report/fdapulse/elucid-plaqueiq-k261855-ma--k261855)
- [Eonis™ SMA kit (K262893): 510(k) cleared for Revvity, Inc.](/report/fdapulse/eonis-sma-kit-k262893-ma--k262893)
- [GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts](/report/fdapulse/gspe-spacer-k260063-ma--k260063)
- [Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc.](/report/fdapulse/integrity-retractable-implant-inserter-6000127-k261869-ma--k261869)
- [multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC](/report/fdapulse/multifiltratepro-system-k261203-ma--k261203)
- [Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26-PH);Normatec Elite Heat (PRO26-PS);Normatec Elite Heat (PRO26-PT) (K261887): 510(k) cleared for NormaTec Industries, LP](/report/fdapulse/normatec-elite-heat-pro26-sh-normatec-elite-heat-pro26-st-ma--k261887)
- [OtoCompanion (Version 1.0) (K261725): 510(k) cleared for Ironsides Medical, Inc.](/report/fdapulse/otocompanion-version-1-0-k261725-ma--k261725)
- [Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Co](/report/fdapulse/q-fix-knotless-all-suture-anchor-1-8mm-with-one-ultrabraid-ma--k263348)
- [Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices](/report/fdapulse/sensinel-cardiopulmonary-management-cpm-system-k260801-ma--k260801)
- [SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) (K262877): 510(k) cleared for Olympus Surgical Technologies America](/report/fdapulse/soltive-laser-system-soltive-pro-superpulsed-laser-soltive-ma--k262877)
- [SpaceOAR Flex™ System (K262151): 510(k) cleared for Boston Scientific Corporation](/report/fdapulse/spaceoar-flex-system-k262151-ma--k262151)
- [ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc.](/report/fdapulse/zsalign-cervical-interbody-system-k263113-ma--k263113)

## Michigan

- [Class II recall Z-0188-2027: Healthmark Industries Co., Inc.](/report/fdapulse/class-ii-recall-z-0188-2027-mi--z-0188-2027)
- [Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, R](/report/fdapulse/neptune-safeair-10ft-smoke-evacuation-pencil-square-coated-mi--k261959)
- [SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000) (K262386): 510(k) cleared for Stryker Instruments](/report/fdapulse/safeair-electrosurgical-generator-with-smoke-evacuation-mi--k262386)
- [Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (](/report/fdapulse/sonopet-iq-series-iii-console-5700-050-000-sonopet-iq-mi--k262244)

## Minnesota

- [Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.](/report/fdapulse/access-bnp-ii-k262597-mn--k262597)
- [Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc.](/report/fdapulse/access-memed-bv-k261109-mn--k261109)
- [Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc.](/report/fdapulse/access-nt-probnp-k262109-mn--k262109)
- [Class II recall Z-0191-2027: Abbott](/report/fdapulse/class-ii-recall-z-0191-2027-mn--z-0191-2027)
- [Class II recall Z-0266-2027: Medtronic Neuromodulation](/report/fdapulse/class-ii-recall-z-0266-2027-mn--z-0266-2027)
- [Class II recall Z-0267-2027: Medtronic Neuromodulation](/report/fdapulse/class-ii-recall-z-0267-2027-mn--z-0267-2027)
- [DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792): 510(k) cleared for Medtronic](/report/fdapulse/dlp-pvc-left-heart-vent-dlp-malleable-pvc-left-heart-vent-mn--k261792)
- [EnSite™ X EP System (K261729): 510(k) cleared for Abbott Medical](/report/fdapulse/ensite-x-ep-system-k261729-mn--k261729)
- [GT Metabolic Magnet System (MAG-04, DS-01)GT Metabolic Magnet System (MAG-05, DS-01) (K261467): 510(k) cleared for Gt Metabolic Solutions, Inc.](/report/fdapulse/gt-metabolic-magnet-system-mag-04-ds-01-gt-metabolic-magnet-mn--k261467)
- [OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc.](/report/fdapulse/openflo-urinary-catheter-k261141-mn--k261141)
- [Protégé™ EverFlex™ Self-expanding Peripheral Stent System (K262913): 510(k) cleared for Medtronic, Inc.](/report/fdapulse/protege-everflex-self-expanding-peripheral-stent-system-mn--k262913)
- [SkinSmart Antimicrobial HydroGel (K254041): 510(k) cleared for Magic Science Supply, LLC](/report/fdapulse/skinsmart-antimicrobial-hydrogel-k254041-mn--k254041)

## Missouri

- [Class II recall Z-3231-2026: Biomerieux Inc](/report/fdapulse/class-ii-recall-z-3231-2026-mo--z-3231-2026)
- [Restrata (K261245): 510(k) cleared for Acera Surgical, Inc.](/report/fdapulse/restrata-k261245-mo--k261245)
- [VITEK 2 AST-Streptococcus Cefepime (=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.](/report/fdapulse/vitek-2-ast-streptococcus-cefepime-0-06-4-g-ml-k260619-mo--k260619)
- [VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc.](/report/fdapulse/vitek-2-ast-streptococcus-meropenem-0-06-4-g-ml-k260283-mo--k260283)

## MY

- [MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD](/report/fdapulse/mowana-auto-duo-k261266-my--k261266)
- [Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fe](/report/fdapulse/non-sterile-powder-free-nitrile-examination-aloe-vera-green-my--k262208)

## N/A

- [Class II recall Z-0077-2027: GRI Medical & Electronic Technology Co., Ltd.](/report/fdapulse/class-ii-recall-z-0077-2027-n-a--z-0077-2027)
- [Class II recall Z-0119-2027: Intellijoint Surgical, Inc.](/report/fdapulse/class-ii-recall-z-0119-2027-n-a--z-0119-2027)

## Nevada

- [FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.](/report/fdapulse/faq-faq-411-k261565-nv--k261565)
- [MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies](/report/fdapulse/micor-700-system-n-a-micor-700-extractor-fg-50621-k262097-nv--k262097)

## New Hampshire

- [Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.](/report/fdapulse/neurora-k260064-nh--k260064)
- [twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.](/report/fdapulse/twiist-loop-algorithm-k262576-nh--k262576)

## New Jersey

- [BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company](/report/fdapulse/bd-vacutainer-serum-blood-collection-tubes-bd-vacutainer-nj--k252344)
- [Class II recall Z-0080-2027: Limitless Cryo Spa LLC](/report/fdapulse/class-ii-recall-z-0080-2027-nj--z-0080-2027)
- [Class II recall Z-0082-2027: DRG International, Inc.](/report/fdapulse/class-ii-recall-z-0082-2027-nj--z-0082-2027)
- [Class II recall Z-0090-2027: Onkos Surgical, Inc.](/report/fdapulse/class-ii-recall-z-0090-2027-nj--z-0090-2027)
- [Class II recall Z-0091-2027: Onkos Surgical, Inc.](/report/fdapulse/class-ii-recall-z-0091-2027-nj--z-0091-2027)
- [Class II recall Z-0164-2027: Howmedica Osteonics Corp.](/report/fdapulse/class-ii-recall-z-0164-2027-nj--z-0164-2027)
- [Class II recall Z-0165-2027: Howmedica Osteonics Corp.](/report/fdapulse/class-ii-recall-z-0165-2027-nj--z-0165-2027)
- [Class II recall Z-0166-2027: Howmedica Osteonics Corp.](/report/fdapulse/class-ii-recall-z-0166-2027-nj--z-0166-2027)
- [Class II recall Z-0167-2027: Howmedica Osteonics Corp.](/report/fdapulse/class-ii-recall-z-0167-2027-nj--z-0167-2027)
- [Class III recall Z-0109-2027: Mindray DS USA, Inc.](/report/fdapulse/class-iii-recall-z-0109-2027-nj--z-0109-2027)

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