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.

New Jersey

• Class III recall Z-0110-2027: Mindray DS USA, Inc.
• Class III recall Z-0111-2027: Mindray DS USA, Inc.
• Class III recall Z-0112-2027: Mindray DS USA, Inc.
• Class III recall Z-0113-2027: Mindray DS USA, Inc.
• Class III recall Z-0114-2027: Mindray DS USA, Inc.
• Class III recall Z-0115-2027: Mindray DS USA, Inc.
• Class III recall Z-0116-2027: Mindray DS USA, Inc.
• STA® - Liquid Anti-Xa (K260214): 510(k) cleared for Diagnostica Stago, Inc.

New York

• Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc.
• Class II recall Z-0107-2027: POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
• Class II recall Z-0204-2027: CooperVision, Inc.
• Class II recall Z-3335-2026: Siemens Healthcare Diagnostics, Inc.
• eClinics (K260075): 510(k) cleared for Ceiba Healthcare US, Inc.
• MICSI-PET (K261305): 510(k) cleared for Microstructure Imaging, Inc.
• ZBPro Diagnostic (Version 2.0) (K261580): 510(k) cleared for Zbeats, Inc.

NL

• GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V.
• Mediclose Cartridge System (K262044): 510(k) cleared for Health Value Creation B.V. (trading as Corporis Medical)
• QGuideCT (1.0) (K260523): 510(k) cleared for Medis Medical Imaging Systems BV

North Carolina

• Class II recall Z-0081-2027: Safeguard US Operating LLC
• Class II recall Z-0200-2027: Greiner Bio-One North America, Inc.
• Class II recall Z-0264-2027: restor3d Inc.
• Class III recall Z-0069-2027: Medical Action Industries, Inc. 306
• Endox Test Strips (K263267): 510(k) cleared for Ibt Scientific
• EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc.
• FINDER Flu A&B/SARS-CoV-2 Test (K261837): 510(k) cleared for Baebies, Inc.
• SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc.
• Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc.

Ohio

• ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc.
• Class II recall Z-0070-2027: Steris Corporation
• Class II recall Z-0071-2027: Steris Corporation
• Class II recall Z-0072-2027: Steris Corporation
• Class II recall Z-0073-2027: Steris Corporation
• Class II recall Z-0074-2027: Steris Corporation
• Class II recall Z-0075-2027: Steris Corporation
• Class II recall Z-0118-2027: Steris Corporation
• Class II recall Z-0144-2027: Sarnova HC, Llc
• Class II recall Z-0145-2027: Ferno-Washington Inc
• Class II recall Z-0154-2027: Steris Corporation
• Class II recall Z-0155-2027: Steris Corporation
• Class II recall Z-0156-2027: Steris Corporation
• Class II recall Z-3217-2026: Midmark Corporation
• Class II recall Z-3218-2026: Midmark Corporation
• Class II recall Z-3219-2026: Midmark Corporation
• Class II recall Z-3289-2026: American Nitrile Operations Llc
• Class II recall Z-3290-2026: American Nitrile Operations Llc
• Class II recall Z-3291-2026: American Nitrile Operations Llc
• Class II recall Z-3292-2026: American Contract Systems Inc
• Class II recall Z-3293-2026: American Contract Systems Inc
• Class II recall Z-3294-2026: American Contract Systems Inc
• Intra-Operative Positioning System (IOPS) and IOPS Visionary System (K263016): 510(k) cleared for Centerline Biomedical
• MEDIVATORS™ ADVANTAGE NXT™ Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris
• Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection) (K260708): 510(k) cleared for Vein 360

Oklahoma

• Everslide (K260117): 510(k) cleared for Special Situations, LLC
• PDR Airway Device (K262937): 510(k) cleared for Park Dental Research Corp.
• Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc.

Oregon

• Fast Absorbing PGLA (K263073): 510(k) cleared for Riverpoint Medical, LLC

Pennsylvania

• 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products
• Altis Full Face Mask (K261262): 510(k) cleared for Respironics, Inc.
• ANTHEM™ Fracture System (K262779): 510(k) cleared for Globus Medical, Inc.
• BoneVue (K254072): 510(k) cleared for Curvebeam AI / Curvebeam, LLC
• Class I recall Z-3252-2026: Draeger, Inc.
• Class II recall Z-0142-2027: Neuronetics, Inc.
• Class II recall Z-0193-2027: B Braun Medical Inc
• Class II recall Z-3247-2026: Olympus Corporation of the Americas
• Class II recall Z-3299-2026: Olympus Corporation of the Americas
• Class II recall Z-3300-2026: Olympus Corporation of the Americas
• Class II recall Z-3329-2026: Olympus Corporation of the Americas
• Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc.
• Liora Monofilament Scaffold (K260474): 510(k) cleared for TELA Bio, Inc.
• 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.
• Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080): 510(k) cleared for Medical Components, Inc.
• prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC
• Tempo Plating System (K263407): 510(k) cleared for Pace Surgical
• VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC
• Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc.

Puerto Rico

• Class II recall Z-0153-2027: Ethicon, LLC
• HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) (K254196): 510(k) cleared for Ethicon Endo-Surgery, LLC

Rhode Island

• Class II recall Z-3253-2026: Criticare Technologies, Inc.
• Phasix ST Parastomal Hernia Mesh (K261543): 510(k) cleared for Davol, Inc., A Subsidiary of C.R. Bard, Inc.

SE

• Echo-2 (K254240): 510(k) cleared for Neko Health AB
• Extroducer Infusion Catheter System (K254051): 510(k) cleared for SmartWise Sweden AB

SG

• Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.
• BCS Bioceramic Sealer (K262478): 510(k) cleared for BCS Device Pte., Ltd.
• Profoject™ LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd.
• Profoject™ Safety Sliding Blood Collection Set (K262215): 510(k) cleared for CMT Health PTE., Ltd.

SI

• Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.

South Carolina

• Glucommander (K261939): 510(k) cleared for Glytec, LLC

Tennessee

• Class II recall Z-0076-2027: QUANTUM OPS Inc
• Class II recall Z-0137-2027: Medtronic Sofamor Danek USA Inc
• Class II recall Z-0138-2027: Medtronic Sofamor Danek USA Inc
• Class II recall Z-0157-2027: In2bones USA, LLC
• Class II recall Z-3334-2026: Wright Medical Technology, Inc.
• NEXUS® Hip Stem (K262473): 510(k) cleared for Microport Orthopedics, Inc.
• syngo.CT Brain Quantification (K260055): 510(k) cleared for Siemens Medical Solutions USA, Inc.
• TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro
• VIRTUE QA (K260597): 510(k) cleared for ProNova Solutions

Texas

• 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) (K261992): 510(k) cleared for Solventum US, LLC
• AerFrame™ Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC
• AltiVate Reverse® Glenosphere with RAVN™ Technology (K263086): 510(k) cleared for Encore Medical L.P.
• Class II recall Z-0067-2027: Custom Interventional Pain Management, LLC
• DASH Flu A/B Test (K261347): 510(k) cleared for Nuclein, LLC
• EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies
• Kinetic Software Library (K260640): 510(k) cleared for Monebo Technologies, Inc.
• Mg OSTEOREVIVE™;Mg OSTEOCRETE™ (K262230): 510(k) cleared for Bone Solutions, Inc.
• MyoVista wavECG (DG-200-B15-003) (K260005): 510(k) cleared for HeartSciences, Inc.
• Ntegrate Threaded Nail System (K261961): 510(k) cleared for Nvision Biomedical Technologies
• Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14) (K260168): 510(k) cleared for Skycade Med Corporation
• SmartRead(TM) Medical Device Identifier (4100) (DEN260007): 510(k) cleared for BridgeSource Medical Corporation

TR

• FRAXION Spinal Fixation System (K262091): 510(k) cleared for Ortler Global Tibbi Gerecler Anonim Sirketi

TW

• EASYMAX Voice Blood Glucose Monitoring System (K261293): 510(k) cleared for EPS Bio Technology Corp.
• OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd.
• 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.
• 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

Utah

• Aristotle 65 Macrowire (K254181): 510(k) cleared for Scientia Vascular
• BIOFIRE Respiratory Panel 2.1 (RP2.1) (K263054): 510(k) cleared for Biofire Diagnostics
• BIOFIRE SPOTFIRE Vaginitis (VG) Panel (K262136): 510(k) cleared for Biofire Diagnostics, LLC
• Class II recall Z-0148-2027: BioFire Diagnostics, LLC
• Class II recall Z-0149-2027: BioFire Diagnostics, LLC
• Class II recall Z-0150-2027: BioFire Diagnostics, LLC
• Class II recall Z-0187-2027: Merit Medical Systems, Inc.
• Class II recall Z-3305-2026: Merit Medical Systems, Inc.
• 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
• OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies
• TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC

Virginia

• Accuro XV (K262093): 510(k) cleared for Rivanna Medical, Inc.
• Class II recall Z-0092-2027: AVID Medical, Inc.
• Class II recall Z-0093-2027: AVID Medical, Inc.
• Class II recall Z-0094-2027: AVID Medical, Inc.
• Class II recall Z-0095-2027: AVID Medical, Inc.
• Class II recall Z-0096-2027: AVID Medical, Inc.
• Class II recall Z-0097-2027: AVID Medical, Inc.
• Class II recall Z-0098-2027: AVID Medical, Inc.
• Class II recall Z-0099-2027: AVID Medical, Inc.
• Class II recall Z-0100-2027: AVID Medical, Inc.
• Class II recall Z-0101-2027: AVID Medical, Inc.
• Class II recall Z-0102-2027: AVID Medical, Inc.
• Class II recall Z-0103-2027: AVID Medical, Inc.
• Class II recall Z-0104-2027: AVID Medical, Inc.
• Class II recall Z-0105-2027: AVID Medical, Inc.
• Class II recall Z-0106-2027: AVID Medical, Inc.
• Class II recall Z-0282-2027: AVID Medical, Inc.
• Class II recall Z-0283-2027: AVID Medical, Inc.

Washington

• Class I recall Z-0122-2027: Ventec Life Systems, Inc.
• Class I recall Z-0123-2027: Ventec Life Systems, Inc.
• Class I recall Z-0124-2027: Ventec Life Systems, Inc.
• Class I recall Z-0125-2027: Ventec Life Systems, Inc.
• Class I recall Z-0126-2027: Ventec Life Systems, Inc.
• Class I recall Z-0127-2027: Ventec Life Systems, Inc.
• Class I recall Z-0128-2027: Ventec Life Systems, Inc.
• Class I recall Z-0129-2027: Ventec Life Systems, Inc.
• Class I recall Z-0130-2027: Ventec Life Systems, Inc.
• Class I recall Z-0131-2027: Ventec Life Systems, Inc.
• Class I recall Z-0132-2027: Ventec Life Systems, Inc.
• Class I recall Z-0133-2027: Ventec Life Systems, Inc.
• Class I recall Z-0152-2027: Philips Ultrasound, LLC
• Class II recall Z-0141-2027: Cadwell Industries Inc
• EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System (K262548): 510(k) cleared for Philips Ultrasound, LLC
• Firstar Dental Electric Motor (K260027): 510(k) cleared for FDC Technology Industry Co.
• Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co.

Wisconsin

• Deterioration Index Version 2 (K260008): 510(k) cleared for Epic Systems Corporation
• EchoPAC Software Only / EchoPAC Plug-in (v211) (K261623): 510(k) cleared for GE Medical Systems Ultrasound and Primary Care Diagnostics
• Lung Guidance (K261042): 510(k) cleared for GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
• Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 (K261933): 510(k) cleared for GE Medical Systems Ultrasound and Primary care Diagnostics, LLC

Wyoming

• Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations

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