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

Bifix Veneer LC, Bifix Veneer Try-In

Voco GmbH

Monkey Bars Pin to Bar External Fixation System

Paragon 28, Inc.

Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (40

Surgical Instrument Service and Savings, Inc.

CHENA-C Spacer System

Kahtnu Surgical, Inc.

Arthrex SutureTak Suture Anchor

Arthrex, Inc.

Glass Ceramics

Yilink (Tianjin) Biotechnology Co., Ltd.

XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter

Transit Scientific, LLC

Bullsai

Turing Medical Technologies, Inc.

SignalNED System (Model RE)

Forest Devices, Inc.

BD Epilor Syringe

Becton, Dickinson and Company

14F iSLEEVE Introducer Set

Boston Scientific Corporation

Legend® Acetabular Shell

Ortho Development Corp.

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA

Orthofix Srl

31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil

Rapid Biomedical GmbH

High speed air turbine handpiece

Foshan Topmed Dental Co., Ltd.

C-Stem AMT LE Prosthesis

Depuy Ireland UC

IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)

Shenzhen Huachuangtong Industrial Co., Ltd.

MIST IC

Imagine Milling Technologies, LLC

Ti Link Abutment

Izenimplant Co., Ltd.

OTTAVA™ Robotic Surgical System

Auris Health, Inc., part of Johnson & Johnson MedTech

CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)

GE Healthcare Finland Oy

Sclerotherapy & Endoscopic Needles

G-Flex Europe Sprl

Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing

Smith & Nephew Medical Limited

Sonio Suspect

Sonio

DESS Dental Smart Solutions

Terrats Medical SL

TELIGEN System

Medos International SARL

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems

Lumenis Be, Inc.

Saige-Dx (3.1.0)

DeepHealth, Inc.

IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 8

Philips Medizin Systeme Böblingen GmbH

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic)

Pegavision Corporation

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