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- Page 4

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

Every FDAPulse record report, 200 per page, grouped by state. Records 601 to 764: Class III recall Z-0110-2027: Mindray DS USA, Inc. to Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations. Source: U.S. FDA openFDA.

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

## New Jersey

- [Class III recall Z-0110-2027: Mindray DS USA, Inc.](/report/fdapulse/class-iii-recall-z-0110-2027-nj--z-0110-2027)
- [Class III recall Z-0111-2027: Mindray DS USA, Inc.](/report/fdapulse/class-iii-recall-z-0111-2027-nj--z-0111-2027)
- [Class III recall Z-0112-2027: Mindray DS USA, Inc.](/report/fdapulse/class-iii-recall-z-0112-2027-nj--z-0112-2027)
- [Class III recall Z-0113-2027: Mindray DS USA, Inc.](/report/fdapulse/class-iii-recall-z-0113-2027-nj--z-0113-2027)
- [Class III recall Z-0114-2027: Mindray DS USA, Inc.](/report/fdapulse/class-iii-recall-z-0114-2027-nj--z-0114-2027)
- [Class III recall Z-0115-2027: Mindray DS USA, Inc.](/report/fdapulse/class-iii-recall-z-0115-2027-nj--z-0115-2027)
- [Class III recall Z-0116-2027: Mindray DS USA, Inc.](/report/fdapulse/class-iii-recall-z-0116-2027-nj--z-0116-2027)
- [STA® - Liquid Anti-Xa (K260214): 510(k) cleared for Diagnostica Stago, Inc.](/report/fdapulse/sta-liquid-anti-xa-k260214-nj--k260214)

## New York

- [Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc.](/report/fdapulse/bausch-lomb-multifocal-for-astigmatism-kalifilcon-a-one-day-ny--k262941)
- [Class II recall Z-0107-2027: POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC](/report/fdapulse/class-ii-recall-z-0107-2027-ny--z-0107-2027)
- [Class II recall Z-0204-2027: CooperVision, Inc.](/report/fdapulse/class-ii-recall-z-0204-2027-ny--z-0204-2027)
- [Class II recall Z-3335-2026: Siemens Healthcare Diagnostics, Inc.](/report/fdapulse/class-ii-recall-z-3335-2026-ny--z-3335-2026)
- [eClinics (K260075): 510(k) cleared for Ceiba Healthcare US, Inc.](/report/fdapulse/eclinics-k260075-ny--k260075)
- [MICSI-PET (K261305): 510(k) cleared for Microstructure Imaging, Inc.](/report/fdapulse/micsi-pet-k261305-ny--k261305)
- [ZBPro Diagnostic (Version 2.0) (K261580): 510(k) cleared for Zbeats, Inc.](/report/fdapulse/zbpro-diagnostic-version-2-0-k261580-ny--k261580)

## NL

- [GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V.](/report/fdapulse/gannet-k262184-nl--k262184)
- [Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical)](/report/fdapulse/mediclose-cartridge-system-k262044-nl--k262044)
- [QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV](/report/fdapulse/qguidect-1-0-k260523-nl--k260523)

## North Carolina

- [Class II recall Z-0081-2027: Safeguard US Operating LLC](/report/fdapulse/class-ii-recall-z-0081-2027-nc--z-0081-2027)
- [Class II recall Z-0200-2027: Greiner Bio-One North America, Inc.](/report/fdapulse/class-ii-recall-z-0200-2027-nc--z-0200-2027)
- [Class II recall Z-0264-2027: restor3d Inc.](/report/fdapulse/class-ii-recall-z-0264-2027-nc--z-0264-2027)
- [Class III recall Z-0069-2027: Medical Action Industries, Inc. 306](/report/fdapulse/class-iii-recall-z-0069-2027-nc--z-0069-2027)
- [Endox Test Strips (K263267): 510(k) cleared for Ibt Scientific](/report/fdapulse/endox-test-strips-k263267-nc--k263267)
- [EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc.](/report/fdapulse/ezsensor-hd-k261663-nc--k261663)
- [FINDER Flu A&B/SARS-CoV-2 Test (K261837): 510(k) cleared for Baebies, Inc.](/report/fdapulse/finder-flu-a-and-b-sars-cov-2-test-k261837-nc--k261837)
- [SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc.](/report/fdapulse/sas-mis-pelvic-incidence-rods-k263172-nc--k263172)
- [Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc.](/report/fdapulse/veritas-shoulder-system-k263421-nc--k263421)

## Ohio

- [ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc.](/report/fdapulse/achm30-atriclip-flex-mini-laa-exclusion-system-k263319-oh--k263319)
- [Class II recall Z-0070-2027: Steris Corporation](/report/fdapulse/class-ii-recall-z-0070-2027-oh--z-0070-2027)
- [Class II recall Z-0071-2027: Steris Corporation](/report/fdapulse/class-ii-recall-z-0071-2027-oh--z-0071-2027)
- [Class II recall Z-0072-2027: Steris Corporation](/report/fdapulse/class-ii-recall-z-0072-2027-oh--z-0072-2027)
- [Class II recall Z-0073-2027: Steris Corporation](/report/fdapulse/class-ii-recall-z-0073-2027-oh--z-0073-2027)
- [Class II recall Z-0074-2027: Steris Corporation](/report/fdapulse/class-ii-recall-z-0074-2027-oh--z-0074-2027)
- [Class II recall Z-0075-2027: Steris Corporation](/report/fdapulse/class-ii-recall-z-0075-2027-oh--z-0075-2027)
- [Class II recall Z-0118-2027: Steris Corporation](/report/fdapulse/class-ii-recall-z-0118-2027-oh--z-0118-2027)
- [Class II recall Z-0144-2027: Sarnova HC, Llc](/report/fdapulse/class-ii-recall-z-0144-2027-oh--z-0144-2027)
- [Class II recall Z-0145-2027: Ferno-Washington Inc](/report/fdapulse/class-ii-recall-z-0145-2027-oh--z-0145-2027)
- [Class II recall Z-0154-2027: Steris Corporation](/report/fdapulse/class-ii-recall-z-0154-2027-oh--z-0154-2027)
- [Class II recall Z-0155-2027: Steris Corporation](/report/fdapulse/class-ii-recall-z-0155-2027-oh--z-0155-2027)
- [Class II recall Z-0156-2027: Steris Corporation](/report/fdapulse/class-ii-recall-z-0156-2027-oh--z-0156-2027)
- [Class II recall Z-3217-2026: Midmark Corporation](/report/fdapulse/class-ii-recall-z-3217-2026-oh--z-3217-2026)
- [Class II recall Z-3218-2026: Midmark Corporation](/report/fdapulse/class-ii-recall-z-3218-2026-oh--z-3218-2026)
- [Class II recall Z-3219-2026: Midmark Corporation](/report/fdapulse/class-ii-recall-z-3219-2026-oh--z-3219-2026)
- [Class II recall Z-3289-2026: American Nitrile Operations Llc](/report/fdapulse/class-ii-recall-z-3289-2026-oh--z-3289-2026)
- [Class II recall Z-3290-2026: American Nitrile Operations Llc](/report/fdapulse/class-ii-recall-z-3290-2026-oh--z-3290-2026)
- [Class II recall Z-3291-2026: American Nitrile Operations Llc](/report/fdapulse/class-ii-recall-z-3291-2026-oh--z-3291-2026)
- [Class II recall Z-3292-2026: American Contract Systems Inc](/report/fdapulse/class-ii-recall-z-3292-2026-oh--z-3292-2026)
- [Class II recall Z-3293-2026: American Contract Systems Inc](/report/fdapulse/class-ii-recall-z-3293-2026-oh--z-3293-2026)
- [Class II recall Z-3294-2026: American Contract Systems Inc](/report/fdapulse/class-ii-recall-z-3294-2026-oh--z-3294-2026)
- [Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical](/report/fdapulse/intra-operative-positioning-system-iops-and-iops-visionary-oh--k263016)
- [MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris](/report/fdapulse/medivators-advantage-nxt-automated-endoscope-reprocessor-oh--k261791)
- [Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection) (K260708): 510(k) cleared for Vein 360](/report/fdapulse/vein360-reprocessed-lithovue-digital-flexible-ureteroscope-oh--k260708)

## Oklahoma

- [Everslide (K260117): 510(k) cleared for Special Situations, LLC](/report/fdapulse/everslide-k260117-ok--k260117)
- [PDR Airway Device (K262937): 510(k) cleared for Park Dental Research Corp.](/report/fdapulse/pdr-airway-device-k262937-ok--k262937)
- [Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc.](/report/fdapulse/sway-system-sports-plus-k262000-ok--k262000)

## Oregon

- [Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC](/report/fdapulse/fast-absorbing-pgla-k263073-or--k263073)

## Pennsylvania

- [25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products](/report/fdapulse/25g-huber-needle-k254095-pa--k254095)
- [Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc.](/report/fdapulse/altis-full-face-mask-k261262-pa--k261262)
- [ANTHEM Fracture System (K262779): 510(k) cleared for Globus Medical, Inc.](/report/fdapulse/anthem-fracture-system-k262779-pa--k262779)
- [BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC](/report/fdapulse/bonevue-k254072-pa--k254072)
- [Class I recall Z-3252-2026: Draeger, Inc.](/report/fdapulse/class-i-recall-z-3252-2026-pa--z-3252-2026)
- [Class II recall Z-0142-2027: Neuronetics, Inc.](/report/fdapulse/class-ii-recall-z-0142-2027-pa--z-0142-2027)
- [Class II recall Z-0193-2027: B Braun Medical Inc](/report/fdapulse/class-ii-recall-z-0193-2027-pa--z-0193-2027)
- [Class II recall Z-3247-2026: Olympus Corporation of the Americas](/report/fdapulse/class-ii-recall-z-3247-2026-pa--z-3247-2026)
- [Class II recall Z-3299-2026: Olympus Corporation of the Americas](/report/fdapulse/class-ii-recall-z-3299-2026-pa--z-3299-2026)
- [Class II recall Z-3300-2026: Olympus Corporation of the Americas](/report/fdapulse/class-ii-recall-z-3300-2026-pa--z-3300-2026)
- [Class II recall Z-3329-2026: Olympus Corporation of the Americas](/report/fdapulse/class-ii-recall-z-3329-2026-pa--z-3329-2026)
- [Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc.](/report/fdapulse/gravity-blood-sets-with-200-m-filter-k260261-pa--k260261)
- [Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc.](/report/fdapulse/liora-monofilament-scaffold-k260474-pa--k260474)
- [MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike (K262043): 510(k) cleared for Bayer Medical Care, Inc.](/report/fdapulse/medrad-mrxperion-mr-injection-system-and-mr-injection-pa--k262043)
- [Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.](/report/fdapulse/pro-line-xl-power-injectable-central-venous-catheter-and-pa--k260080)
- [prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC](/report/fdapulse/prodisc-c-prodisc-c-sk-prodisc-c-nova-prodisc-c-vivo-pa--k263159)
- [Tempo Plating System (K263407): 510(k) cleared for Pace Surgical](/report/fdapulse/tempo-plating-system-k263407-pa--k263407)
- [VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC](/report/fdapulse/vacheal-negative-pressure-wound-therapy-system-k254160-pa--k254160)
- [Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.](/report/fdapulse/ventricular-catheters-thomale-catheter-k260044-pa--k260044)

## Puerto Rico

- [Class II recall Z-0153-2027: Ethicon, LLC](/report/fdapulse/class-ii-recall-z-0153-2027-pr--z-0153-2027)
- [HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC](/report/fdapulse/harmonic-1100-shears-har1120-harmonic-1100-shears-har1136-pr--k254196)

## Rhode Island

- [Class II recall Z-3253-2026: Criticare Technologies, Inc.](/report/fdapulse/class-ii-recall-z-3253-2026-ri--z-3253-2026)
- [Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc.](/report/fdapulse/phasix-st-parastomal-hernia-mesh-k261543-ri--k261543)

## SE

- [Echo-2 (K254240): 510(k) cleared for Neko Health AB](/report/fdapulse/echo-2-k254240-se--k254240)
- [Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB](/report/fdapulse/extroducer-infusion-catheter-system-k254051-se--k254051)

## SG

- [Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.](/report/fdapulse/aevice-wheeze-detection-module-k260140-sg--k260140)
- [BCS Bioceramic Sealer (K262478): 510(k) cleared for BCS Device Pte., Ltd.](/report/fdapulse/bcs-bioceramic-sealer-k262478-sg--k262478)
- [Profoject LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd.](/report/fdapulse/profoject-lor-syringe-k261372-sg--k261372)
- [Profoject Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd.](/report/fdapulse/profoject-safety-sliding-blood-collection-set-k262215-sg--k262215)

## SI

- [Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.](/report/fdapulse/dynamis-pro-family-k252723-si--k252723)

## South Carolina

- [Glucommander (K261939): 510(k) cleared for Glytec, LLC](/report/fdapulse/glucommander-k261939-sc--k261939)

## Tennessee

- [Class II recall Z-0076-2027: QUANTUM OPS Inc](/report/fdapulse/class-ii-recall-z-0076-2027-tn--z-0076-2027)
- [Class II recall Z-0137-2027: Medtronic Sofamor Danek USA Inc](/report/fdapulse/class-ii-recall-z-0137-2027-tn--z-0137-2027)
- [Class II recall Z-0138-2027: Medtronic Sofamor Danek USA Inc](/report/fdapulse/class-ii-recall-z-0138-2027-tn--z-0138-2027)
- [Class II recall Z-0157-2027: In2bones USA, LLC](/report/fdapulse/class-ii-recall-z-0157-2027-tn--z-0157-2027)
- [Class II recall Z-3334-2026: Wright Medical Technology, Inc.](/report/fdapulse/class-ii-recall-z-3334-2026-tn--z-3334-2026)
- [NEXUS® Hip Stem (K262473): 510(k) cleared for Microport Orthopedics, Inc.](/report/fdapulse/nexus-hip-stem-k262473-tn--k262473)
- [syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc.](/report/fdapulse/syngo-ct-brain-quantification-k260055-tn--k260055)
- [TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro](/report/fdapulse/tekbrace-knotless-anchor-k263352-tn--k263352)
- [VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions](/report/fdapulse/virtue-qa-k260597-tn--k260597)

## Texas

- [3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC](/report/fdapulse/3m-attest-steam-chemical-integrator-1243a-1243b-1243re-tx--k261992)
- [AerFrame Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC](/report/fdapulse/aerframe-alignment-laser-box-lbv2-k261865-tx--k261865)
- [AltiVate Reverse® Glenosphere with RAVN Technology (K263086): 510(k) cleared for Encore Medical L.P.](/report/fdapulse/altivate-reverse-glenosphere-with-ravn-technology-k263086-tx--k263086)
- [Class II recall Z-0067-2027: Custom Interventional Pain Management, LLC](/report/fdapulse/class-ii-recall-z-0067-2027-tx--z-0067-2027)
- [DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC](/report/fdapulse/dash-flu-a-b-test-k261347-tx--k261347)
- [EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies](/report/fdapulse/enhance-peek-bunion-system-k262098-tx--k262098)
- [Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.](/report/fdapulse/kinetic-software-library-k260640-tx--k260640)
- [Mg OSTEOREVIVE;Mg OSTEOCRETE (K262230): 510(k) cleared for Bone Solutions, Inc.](/report/fdapulse/mg-osteorevive-mg-osteocrete-k262230-tx--k262230)
- [MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.](/report/fdapulse/myovista-wavecg-dg-200-b15-003-k260005-tx--k260005)
- [Ntegrate Threaded Nail System (K261961): 510(k) cleared for Nvision Biomedical Technologies](/report/fdapulse/ntegrate-threaded-nail-system-k261961-tx--k261961)
- [Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation](/report/fdapulse/small-diameter-core-wire-cman-000-00-small-diameter-core-tx--k260168)
- [SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation](/report/fdapulse/smartread-tm-medical-device-identifier-4100-den260007-tx--den260007)

## TR

- [FRAXION Spinal Fixation System (K262091): 510(k) cleared for Ortler Global Tibbi Gerecler Anonim Sirketi](/report/fdapulse/fraxion-spinal-fixation-system-k262091-tr--k262091)

## TW

- [EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.](/report/fdapulse/easymax-voice-blood-glucose-monitoring-system-k261293-tw--k261293)
- [OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd.](/report/fdapulse/ooopds-k254214-tw--k254214)
- [OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens (K253875): 510(k) cleared for Visco Vision, Inc.](/report/fdapulse/oxypure-olifilcon-a-spherical-biweekly-silicone-hydrogel-tw--k253875)
- [Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation](/report/fdapulse/venti-trach-tracheostomy-tube-570-series-venti-trach-tw--k253063)

## Utah

- [Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular](/report/fdapulse/aristotle-65-macrowire-k254181-ut--k254181)
- [BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire Diagnostics](/report/fdapulse/biofire-respiratory-panel-2-1-rp2-1-k263054-ut--k263054)
- [BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC](/report/fdapulse/biofire-spotfire-vaginitis-vg-panel-k262136-ut--k262136)
- [Class II recall Z-0148-2027: BioFire Diagnostics, LLC](/report/fdapulse/class-ii-recall-z-0148-2027-ut--z-0148-2027)
- [Class II recall Z-0149-2027: BioFire Diagnostics, LLC](/report/fdapulse/class-ii-recall-z-0149-2027-ut--z-0149-2027)
- [Class II recall Z-0150-2027: BioFire Diagnostics, LLC](/report/fdapulse/class-ii-recall-z-0150-2027-ut--z-0150-2027)
- [Class II recall Z-0187-2027: Merit Medical Systems, Inc.](/report/fdapulse/class-ii-recall-z-0187-2027-ut--z-0187-2027)
- [Class II recall Z-3305-2026: Merit Medical Systems, Inc.](/report/fdapulse/class-ii-recall-z-3305-2026-ut--z-3305-2026)
- [Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System (K262025): 510(k) cleared for INNO Holdings Inc. DBA Innovasis](/report/fdapulse/innovasis-axtiha-stand-alone-alif-system-innovasis-txtiha-ut--k262025)
- [OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies](/report/fdapulse/osteocentric-technologies-cannulated-and-soild-fasteners-ut--k263116)
- [TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC](/report/fdapulse/truvision-single-use-1-9mm-arthroscopy-system-k260156-ut--k260156)

## Virginia

- [Accuro XV (K262093): 510(k) cleared for Rivanna Medical, Inc.](/report/fdapulse/accuro-xv-k262093-va--k262093)
- [Class II recall Z-0092-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0092-2027-va--z-0092-2027)
- [Class II recall Z-0093-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0093-2027-va--z-0093-2027)
- [Class II recall Z-0094-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0094-2027-va--z-0094-2027)
- [Class II recall Z-0095-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0095-2027-va--z-0095-2027)
- [Class II recall Z-0096-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0096-2027-va--z-0096-2027)
- [Class II recall Z-0097-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0097-2027-va--z-0097-2027)
- [Class II recall Z-0098-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0098-2027-va--z-0098-2027)
- [Class II recall Z-0099-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0099-2027-va--z-0099-2027)
- [Class II recall Z-0100-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0100-2027-va--z-0100-2027)
- [Class II recall Z-0101-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0101-2027-va--z-0101-2027)
- [Class II recall Z-0102-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0102-2027-va--z-0102-2027)
- [Class II recall Z-0103-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0103-2027-va--z-0103-2027)
- [Class II recall Z-0104-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0104-2027-va--z-0104-2027)
- [Class II recall Z-0105-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0105-2027-va--z-0105-2027)
- [Class II recall Z-0106-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0106-2027-va--z-0106-2027)
- [Class II recall Z-0282-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0282-2027-va--z-0282-2027)
- [Class II recall Z-0283-2027: AVID Medical, Inc.](/report/fdapulse/class-ii-recall-z-0283-2027-va--z-0283-2027)

## Washington

- [Class I recall Z-0122-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0122-2027-wa--z-0122-2027)
- [Class I recall Z-0123-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0123-2027-wa--z-0123-2027)
- [Class I recall Z-0124-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0124-2027-wa--z-0124-2027)
- [Class I recall Z-0125-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0125-2027-wa--z-0125-2027)
- [Class I recall Z-0126-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0126-2027-wa--z-0126-2027)
- [Class I recall Z-0127-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0127-2027-wa--z-0127-2027)
- [Class I recall Z-0128-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0128-2027-wa--z-0128-2027)
- [Class I recall Z-0129-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0129-2027-wa--z-0129-2027)
- [Class I recall Z-0130-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0130-2027-wa--z-0130-2027)
- [Class I recall Z-0131-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0131-2027-wa--z-0131-2027)
- [Class I recall Z-0132-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0132-2027-wa--z-0132-2027)
- [Class I recall Z-0133-2027: Ventec Life Systems, Inc.](/report/fdapulse/class-i-recall-z-0133-2027-wa--z-0133-2027)
- [Class I recall Z-0152-2027: Philips Ultrasound, LLC](/report/fdapulse/class-i-recall-z-0152-2027-wa--z-0152-2027)
- [Class II recall Z-0141-2027: Cadwell Industries Inc](/report/fdapulse/class-ii-recall-z-0141-2027-wa--z-0141-2027)
- [EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC](/report/fdapulse/epiq-inspira-series-diagnostic-ultrasound-system-affiniti-wa--k262548)
- [Firstar Dental Electric Motor (K260027): 510(k) cleared for FDC Technology Industry Co.](/report/fdapulse/firstar-dental-electric-motor-k260027-wa--k260027)
- [Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co.](/report/fdapulse/firstar-dental-handpieces-k260029-wa--k260029)

## Wisconsin

- [Deterioration Index Version 2 (K260008): 510(k) cleared for Epic Systems Corporation](/report/fdapulse/deterioration-index-version-2-k260008-wi--k260008)
- [EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics](/report/fdapulse/echopac-software-only-echopac-plug-in-v211-k261623-wi--k261623)
- [Lung Guidance (K261042): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC](/report/fdapulse/lung-guidance-k261042-wi--k261042)
- [Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K261933): 510(k) cleared for GE Medical Systems Ultrasound and Primary care Diagnostics, LLC](/report/fdapulse/voluson-expert-18-voluson-expert-20-voluson-expert-22-wi--k261933)

## Wyoming

- [Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations](/report/fdapulse/freedom-nail-ankle-fusion-system-k261189-wy--k261189)

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