RecallHawk

510(k) Device Clearances

Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.

15,000 total clearances

Non-sterile, Powder-Free Latex Examination Glove

Sri Trang Gloves (Thailand) Public Company Limited

Picosecond Nd:YAG Laser System; PICO LEGEND

Ami, Inc.

Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs)

Mezorrison Medical Technology (Dongying) Co., Ltd.

Aspirex™ Thrombectomy System

C.R. Bard, Inc.

Parietene™ Macroporous Mesh (PPM5050 )

Sofradim Production

Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors

Gm Dos Reis Industria E Comerico Ltda.

Heel Incision Safety Lancet

SteriLance Medical (Suzhou), Inc.

CELERITY HP Chemical Indicator

STERIS Corporation

Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope

Shanghai Caremate Medical Device Co., Ltd.

Polyfusion IV Administration Sets

Poly Medicure Limited

Scaida BrainCT-ICH (v1.0)

Mlhealth 360

Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays

Exactech, Inc.

Disposable Endoscopic Distal Attachments

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G

Blue Sky Bio, LLC

ROSA Hip System

Orthosoft D/B/A Zimmer Cas

RefleXion Medical Radiotherapy System (RMRS)

Reflexion Medical, Inc.

Veloxion System

Corinth Medtech, Inc.

Stryker Resorbable Fixation System

Stryker Leibinger GmbH & Co KG

Nanox.ARC

Nano-X Imaging , Ltd.

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette

Plasmapp Co,., Ltd.

StealthStation S8 Spine Software

Medtronic Navigation, Inc.

Access AMH

Beckman Coulter, Inc.

EndoCore

Praxis Medical, LLC

VERTICALE® Navigation Instruments

Silony Medical GmbH

Applanation Tonometer HT-5000

Huvitz Co., Ltd.

QuietLab Pro

QuietLab, LLC

TENS&EMS units (SM9109A, SM9109B)

Plexus Yoga, LLC Dba Chirp

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

Hearx SA (Pty) , Ltd.

Southern Implants Instrument Trays

Southern Implants (Pty), Ltd.

Minder System

Epi-Minder Pty, Ltd.

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