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.

Illinois

• Class II recall Z-0169-2027: Medline Industries, LP
• Class II recall Z-0170-2027: Medline Industries, LP
• Class II recall Z-0171-2027: Medline Industries, LP
• Class II recall Z-0172-2027: Medline Industries, LP
• Class II recall Z-0173-2027: Medline Industries, LP
• Class II recall Z-0174-2027: Medline Industries, LP
• Class II recall Z-0175-2027: Medline Industries, LP
• Class II recall Z-0176-2027: Medline Industries, LP
• Class II recall Z-0177-2027: Medline Industries, LP
• Class II recall Z-0178-2027: Medline Industries, LP
• Class II recall Z-0179-2027: Medline Industries, LP
• Class II recall Z-0180-2027: Medline Industries, LP
• Class II recall Z-0181-2027: Medline Industries, LP
• Class II recall Z-0182-2027: Medline Industries, LP
• Class II recall Z-0183-2027: Medline Industries, LP
• Class II recall Z-0184-2027: Medline Industries, LP
• Class II recall Z-0185-2027: Medline Industries, LP
• Class II recall Z-0189-2027: Medline Industries, LP
• Class II recall Z-0269-2027: Medline Industries, LP
• Class II recall Z-0270-2027: Medline Industries, LP
• Class II recall Z-0271-2027: Medline Industries, LP
• Class II recall Z-0272-2027: Medline Industries, LP
• Class II recall Z-0273-2027: Medline Industries, LP
• Class II recall Z-0274-2027: Medline Industries, LP
• Class II recall Z-0275-2027: Medline Industries, LP
• Class II recall Z-0276-2027: Medline Industries, LP
• Class II recall Z-0277-2027: Medline Industries, LP
• Class II recall Z-0278-2027: Medline Industries, LP
• Class II recall Z-0279-2027: Medline Industries, LP
• Class II recall Z-0280-2027: Medline Industries, LP
• Class II recall Z-0281-2027: Medline Industries, LP
• Class II recall Z-3229-2026: Medline Industries, LP
• Class II recall Z-3295-2026: Cardinal Health 200, LLC
• Class II recall Z-3296-2026: Cardinal Health 200, LLC
• Class II recall Z-3297-2026: Cardinal Health 200, LLC
• Class II recall Z-3298-2026: Cardinal Health 200, LLC
• Ecomed Disposable Administration Sets (K254123): 510(k) cleared for Ecomed Solutions, LLC
• Elecsys HBsAg II quant II RxDx (DEN260027): 510(k) cleared for Roche Diagnostics
• Embrace Vision Neonatal MRI System (K261758): 510(k) cleared for Aspect Imaging, Ltd.
• Hyperdrive 35 Guidewire (K253146): 510(k) cleared for Rapid-Medical , Ltd.
• LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc.
• MeCare Alpha (MCA2019) (K260426): 510(k) cleared for IVT Medical, Ltd.
• MultiNeO Dental Implant System (K261295): 510(k) cleared for Alpha Bio Tec , Ltd.
• NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) (K262532): 510(k) cleared for ICU Medical
• SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd.
• 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.
• Tempus ECG-MR (K254297): 510(k) cleared for Tempus AI, Inc.
• TumorSight Risk (K260023): 510(k) cleared for SimBioSys, Inc.

Indiana

• Class II recall Z-0163-2027: Cook Incorporated
• Class II recall Z-0201-2027: Beckman Coulter, Inc.
• Class II recall Z-0202-2027: Beckman Coulter, Inc.
• Duet™ Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC
• Elecsys EBV EBNA IgG (K260221): 510(k) cleared for Roche Diagnostics
• Elecsys EBV IgM (K260233): 510(k) cleared for Roche Diagnostics
• Elecsys EBV VCA IgG (K260232): 510(k) cleared for Roche Diagnostics
• G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet
• Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd.
• OsseoFit Stemless Shoulder System (K262955): 510(k) cleared for Zimmer, Inc.
• Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp.
• 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
• qCT Lung (v1.0) (K261517): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd.

Iowa

• Align® Cover and Pad Guidance Tool (K260114): 510(k) cleared for CIVCO Medical Instruments Co., Inc.
• MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc.

IT

• Digistat Care (K261287): 510(k) cleared for Ascom Ums Srl Unipersonale
• Dual Stage Venous Cannulae (K263092): 510(k) cleared for Sorin Group Italia S.R.L.
• HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): 510(k) cleared for Eurosets S.R.L
• Plenity-V (MC0979 / GS110) (K261783): 510(k) cleared for Gelesis SRL
• Tri Stage Venous Cannulae (K262052): 510(k) cleared for Sorin Group Italia S.R.L.
• Vessel Closure Device (VCD177213P) (K260677): 510(k) cleared for Vcd Medical S.R.L.

JP

• APERTO Lucent MRI System (K261283): 510(k) cleared for Fujifilm Corporation
• CuratOR EX2742 (K262397): 510(k) cleared for Eizo Corporation
• DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd.
• ECHELON Synergy (K262902): 510(k) cleared for Fujifilm Corporation
• KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory
• Lilium one (USM330) (K260605): 510(k) cleared for Lilium Otsuka Co., Ltd.
• Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd.
• SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation
• SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation
• TSK OptiXion (K262516): 510(k) cleared for Tsk Laboratory, Japan

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

KR

• Amber Arte (K262523): 510(k) cleared for Hass Corp.
• AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd.
• AVIEW Aorta Metrics (K260391): 510(k) cleared for Coreline Soft Co., Ltd.
• cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc.
• cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc.
• Cemented Plus Abutment (K262207): 510(k) cleared for Unidental Co., Ltd.
• Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd.
• CVS Advanced PLUS Blood Glucose Monitoring System (K260689): 510(k) cleared for I-Sens, Inc.
• Dia-X Sil Heavy Body (K254142): 510(k) cleared for DiaDent Group International
• Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International
• Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc.
• ECG Analysis Software (AiTiALVSD) (K254302): 510(k) cleared for Medical AI Co., Ltd.
• EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd.
• 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
• INNI-CERA (BCM-W500, BCM-W1000) (K262980): 510(k) cleared for DentMedi Co., Ltd.
• Medical Monitor (32MD08WC) (K262985): 510(k) cleared for Lg Electronics.Inc
• MINT MONO Sutures (K254238): 510(k) cleared for Hans Biomed Corporation
• NeckTune™ SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd.
• NEXT-Cue (K261805): 510(k) cleared for Neuroxt, Inc.
• NOVIX Pedicle Screw System (K263062): 510(k) cleared for Tdm Co., Ltd.
• Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd.
• OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd.
• Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd.
• PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.
• Potenza Prime (K254185): 510(k) cleared for Jeisys Medical Incorporated
• REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210): 510(k) cleared for Hyundai Bioland Co., Ltd.
• REMEX-T(K)100C (K261943): 510(k) cleared for Remedi, Inc.
• S-Patch CardioAI (K254255): 510(k) cleared for Wellysis Corp.
• SwiftSight-BodyComposition (K261612): 510(k) cleared for Airs Medical, Inc.
• TDM Large Bone Plate and Screw System (K261611): 510(k) cleared for Tdm Co., Ltd.
• The VEGA Cervical Screw System (K254260): 510(k) cleared for GS Medical Co., Ltd.
• 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

LT

• Ligence Heart (K261733): 510(k) cleared for UAB Ligence

LU

• SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A.

Maine

• Class II recall Z-0268-2027: Solstice Corporation
• SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control (K262573): 510(k) cleared for Maine Molecular Quality Controls, Inc.

Maryland

• BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (K262163): 510(k) cleared for Becton Dickinson and Company
• Class II recall Z-0139-2027: Becton Dickinson & Co.
• Class II recall Z-0140-2027: Becton Dickinson & Co.
• CraniUS Plate (K262874): 510(k) cleared for CraniUS, LLC
• Oncomine ™ Dx Express Test (K260827): 510(k) cleared for Life Technologies Corporation

Massachusetts

• a2z-Abdo-Triage (K260906): 510(k) cleared for A2z Radiology Ai, Inc.
• BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125): 510(k) cleared for Samsung HME America, Inc., dba NeuroLogica Corp.
• BTL-299-F (K262353): 510(k) cleared for BTL Industries, Inc.
• Class I recall Z-0001-2027: Instrumentation Laboratory
• Class I recall Z-0002-2027: Instrumentation Laboratory
• Class II recall Z-0078-2027: PHILIPS MEDICAL SYSTEMS
• Class II recall Z-0117-2027: LeMaitre Vascular, Inc.
• Class II recall Z-0143-2027: Boston Scientific Corporation
• Class II recall Z-0199-2027: Philips North America
• Class II recall Z-3155-2026: Philips North America Llc
• Class II recall Z-3225-2026: Fresenius Medical Care Renal Therapies Group, LLC
• Class II recall Z-3233-2026: Philips North America Llc
• Class II recall Z-3239-2026: Philips North America Llc
• Class II recall Z-3242-2026: Philips North America Llc
• Class II recall Z-3251-2026: Abiomed, Inc.
• Class II recall Z-3307-2026: Philips North America
• Class II recall Z-3308-2026: Philips North America
• Class II recall Z-3309-2026: Philips North America
• Class II recall Z-3310-2026: Philips North America
• Class II recall Z-3311-2026: Philips North America
• Class II recall Z-3312-2026: Philips North America
• Class II recall Z-3313-2026: Philips North America
• Class II recall Z-3314-2026: Philips North America
• Class II recall Z-3315-2026: Philips North America
• Class II recall Z-3316-2026: Philips North America
• Class II recall Z-3317-2026: Philips North America
• Class II recall Z-3318-2026: Philips North America
• Class III recall Z-0162-2027: Magellan Diagnostics, Inc.
• Elucid FFR-IQ (B.1) (K262015): 510(k) cleared for Elucid Bioimaging, Inc.
• Elucid PlaqueIQ (K261855): 510(k) cleared for Elucid Bioimaging, Inc.
• Eonis™ SMA kit (K262893): 510(k) cleared for Revvity, Inc.
• GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts
• Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc.
• multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC
• 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
• OtoCompanion (Version 1.0) (K261725): 510(k) cleared for Ironsides Medical, Inc.
• 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
• Sensinel Cardiopulmonary Management (CPM) System (K260801): 510(k) cleared for Analog Devices
• 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
• SpaceOAR Flex™ System (K262151): 510(k) cleared for Boston Scientific Corporation
• ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc.

Michigan

• Class II recall Z-0188-2027: Healthmark Industries Co., Inc.
• 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
• SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch (0795-007-000) (K262386): 510(k) cleared for Stryker Instruments
• 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 (

Minnesota

• Access BNP II (K262597): 510(k) cleared for Beckman Coulter, Inc.
• Access MeMed BV (K261109): 510(k) cleared for Beckman Coulter, Inc.
• Access NT-proBNP (K262109): 510(k) cleared for Beckman Coulter, Inc.
• Class II recall Z-0191-2027: Abbott
• Class II recall Z-0266-2027: Medtronic Neuromodulation
• Class II recall Z-0267-2027: Medtronic Neuromodulation
• DLP PVC Left Heart Vent; DLP Malleable PVC Left Heart Vent; DLP Silicone Left Heart Vent (K261792): 510(k) cleared for Medtronic
• EnSite™ X EP System (K261729): 510(k) cleared for Abbott Medical
• 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.
• OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc.
• Protégé™ EverFlex™ Self-expanding Peripheral Stent System (K262913): 510(k) cleared for Medtronic, Inc.
• SkinSmart Antimicrobial HydroGel (K254041): 510(k) cleared for Magic Science Supply, LLC

Missouri

• Class II recall Z-3231-2026: Biomerieux Inc
• Restrata (K261245): 510(k) cleared for Acera Surgical, Inc.
• VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL) (K260619): 510(k) cleared for Biomérieux, Inc.
• VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL) (K260283): 510(k) cleared for bioMerieux, Inc.

MY

• MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD
• 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

N/A

• Class II recall Z-0077-2027: GRI Medical & Electronic Technology Co., Ltd.
• Class II recall Z-0119-2027: Intellijoint Surgical, Inc.

Nevada

• FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.
• MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies

New Hampshire

• Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc.
• twiist Loop Algorithm (K262576): 510(k) cleared for Deka Research and Development Corp.

New Jersey

• BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST) (K252344): 510(k) cleared for Becton, Dickinson and Company
• Class II recall Z-0080-2027: Limitless Cryo Spa LLC
• Class II recall Z-0082-2027: DRG International, Inc.
• Class II recall Z-0090-2027: Onkos Surgical, Inc.
• Class II recall Z-0091-2027: Onkos Surgical, Inc.
• Class II recall Z-0164-2027: Howmedica Osteonics Corp.
• Class II recall Z-0165-2027: Howmedica Osteonics Corp.
• Class II recall Z-0166-2027: Howmedica Osteonics Corp.
• Class II recall Z-0167-2027: Howmedica Osteonics Corp.
• Class III recall Z-0109-2027: Mindray DS USA, Inc.

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