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

Small Volume 0.2mL Syringe

Prosum Medical Limited

Steam Sterilizer (2545D)

Ningbo Ican Machines Co., Ltd.

Orthoscan TAU Mini C-Arm

Ziehm-Orthoscan, Inc.

Viz SDH

Viz. Ai, Inc.

8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

Shenzhen Beacon Display Technology Co., Ltd.

ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)

Sofradim Production

Oscar Peripheral Multifunctional Catheter system

Biotronik, Inc.

ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System

Spinecraft, LLC

CP Relief Wand Rx - TENS/NMES

N & C Holdings, LLC

Plus Medical Chemotherapy Gown

Foshan Nanhai Plus Medical Co, Ltd.

EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III

Olympus Medical Systems Corp.

ProtekDilate Vascular Access Kit

Sorin Group Italia S.R.L.

XC11 ICE System, USA

Yorlabs, Inc.

Digital Radiography System (ManntiX B, ManntiX K)

Shenzhen Browiner Tech Co., Ltd.

Omnifix Syringe NRFit

B.Braun Medical, Inc.

Dayspring Lite

Koya Medical, Inc.

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

Specific Diagnostics, LLC

Disposable Extension Set

Shandong Ande Healthcare Apparatus Co., Ltd.

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter

Silk Road Medical, Inc.

Nutrifit

Vygon USA

Aesculap Slim Clip Applier

Aesculap, Inc.

LUTRONIC GENIUS

Cynosure Lutronic Technology Corporation

Neowise

Cefla S.C.

Arthrex Virtual Implant Positioning (VIP) System

Arthrex, Inc.

Disposable Nitrile Examination Gloves (Powder free, Blue)

Leping Shengde Medical Technology Company Limited

HexaPLUS S OneDrill Implant System

Osseofuse International, Inc.

Blue Topaz Sacroiliac Screw System

Osseus Fusion Systems, LLC

Polyshield Safety IV Catheters

Poly Medicure Limited

HandPICO

Vydence Medical Industria E Comercio Ltda

SyMRI

Syntheticmr AB

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