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

3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ A

3M Company

Withings BeamO (SCT02)

Withings

Faros Surgical System

Oertli Instrumente AG

Arthrex Humeral Nails

Arthrex, Inc.

Phagenyx System

Phagenesis Limited

Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)

Ningbo Ranor Medical Technology Co., Ltd.

Vital™ Spinal Fixation System

Zimvie Spine (Zimmer Biomet Spine, Inc.)

Philips IntelliSite Pathology Solution

Philips Medical Systems Nederland B.V.

Normatec Elite Hip

NormaTec Industries, LP

Disposable Vinyl/Nitrile Blend Medical Examination Gloves

Bytech(Dongtai) Co., Ltd.

NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)

Nb Medical Company Limited

BEAR® (Bridge-Enhanced ACL Restoration) Implant

Miach Orthopaedics, Inc.

Niti-S Biliary Speed D Stent

Taewoong Medical Co., Ltd.

EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)

Olympus Medical Systems Corp.

VerteLoc Spinal System

Signature Orthopaedics Pty, Ltd.

DD Hybridlayer (multicolored zirconia)

Dental Direkt GmbH

Nitrile Examination Glove, Pink Color; Nitrile Examination Glove, Black Color, Nitrile Examination Glove, White Color

Guangdong Kingfa Sci. & Tech.Co., Ltd.

HYALOMATRIX

Anika Therapeutics, Inc.

Needle Stimulator (CMNS6-1 PLUS, CMNS6-3)

Wuxi Jiajian Medical Instrument Co., Ltd.

YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff

Nihon Kohden Corporation

EnDrive (EnDriveUS)

Advanced Technology Research (A.T.R.) S.R.L.

Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)

Arc Trauma, LLC

32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open N

Neocoil, LLC

Vent Creativity Knee v1.0 (Hermes)

Vent Creativity

ExcelsiusGPS™ Instruments

Globus Medical, Inc.

CardIQ Suite

GE Medical Systems SCS

Alinity i STAT High Sensitivity Troponin-I

Abbott Laboratories Diagnostics Division

MSFX Mikron Cervical Anterior Plate System

Mikron Makina Sanayi VE Ticaret Ltd. Sti.

PlanOne 1

Cosylab Jsc, Control System Laboratory

eFOLDi Scooter, Lite

Suntech UK , Ltd.

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