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

FairFix Adjustable Button System

Medacta International S.A.

MDx-Chex for BCID2

Streck, Inc.

EchoPAC Software Only / EchoPAC Plug-in (v211)

GE Medical Systems Ultrasound and Primary Care Diagnostics

Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

Route 92 Medical, Inc.

TOSAMA Reusable Applicator

Tosama, D.O.O.

Ascension Silicone MCP; Ascension Silicone PIP

Ascension Orthopedics, Inc.

MR Diffusion Perfusion Mismatch V1.0

Olea Medical

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD

Boston Scientific Corporation

zirkon; structure; LFU shades, stains and glazes

Estetic Ceram AG

Neonav ECG Tip Location System

Navi Medical Technologies

T-FIX™ 3DSI Joint Fusion System

Cutting Edge Spine, LLC

Evo® sEEG System

Neuroone Medical Technologies Corp.

Glovmaster Nitrile Examination Glove Powder Free

Glovmaster Sdn. Bhd.

AnyPlus II Spinal Fixation System

GS Medical Co., Ltd.

Protect-It Custom Fit Dental Guard

Doc Brands, Inc.

RadiForce MX317W-PA

Eizo Corporation

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free

Srirungruang Global Co., Ltd.

iLet Dosing Decision Software

Beta Bionics, Inc.

EasyScreen Gastrointestinal Parasite Detection Kit

Genetic Signatures Limited

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

Biomet, Inc.

Medi Lift Essential Eye Mask

Ya-Man, Ltd.

SofWave System

Sofwave Medical, Ltd.

Rapid Aortic Measurements

Ischemaview, Inc.

InfaTherm Disposable Infant Warming Mattress

International Biomedical

Aneroid Sphygmomanometer; Single Patient Use Aneroid Sphygmomanometer

Cardicare Company, Ltd.

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)

Wuxi Jiajian Medical Instrument Co., Ltd.

XERF

Lutronic Corporation

IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straigh

Boston Scientific Corp

Viz Subdural+, Viz SUBDURAL PLUS

Viz. Ai, Inc.

Brainance MD

Advantis Medical Imaging Single Member P.C.

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