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

Xpert Wrist

Newclip Technics

LINQ II™ Insertable Cardiac Monitor (ICM)

Medtronic, Inc.

21HQ513D

Lg Electronics.Inc

Feeding Tube

Anhui Tiankang Medical Technology Co., Ltd.

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System w

Thermo Fisher Scientific

DRPx Locking Distal Radius Plate System

Orthopaedic Implant Company

A’TOMIC™ Nitinol Fixation System

Rmr Ortho, LLC

syngo Application Software

Siemens Medical Solutions USA, Inc.

14HQ721G-B

Lg Electronics.Inc

InVision™ 3T Recharge Operating Suite

Imris Imaging, Inc.

Atalante

Wandercraft SAS

Alio

Alio, Inc.

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

ViVi® Toga Premium

Thi Total Healthcare Innovation GmbH

Quantum Mitohormesis (QMT) (M2101)

Quantumtx Pte. , Ltd.

ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

Olympus Medical Systems Corporation

EMPOWR Acetabular® Liner Extension

Encore Medical L.P.

Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P

Cochlear

Cryopush Cold Compression Device (A02-P-001)

Chengdu Cryo-Push Medical Technology Co.,Ltd

neo315

Neoscan Solution GmbH

Custom-made Invisible Aligners

Zhejiang Yinchili Medical Technology Co., Ltd.

ROSA® Shoulder System

Orthosoft Inc (D/B/A Zimmer Cas)

Sonicaid Team3

Huntleigh Healthcare , Ltd.

CareSuperb COVID-19/Flu A&B Antigen Combo Home Test

Access Bio, Inc.

CO2 Laser Therapy System (Model: LFS-D9U)

Sanhe Lefis Electronics Co., Ltd.

uMI Panvivo

Shanghai United Imaging Healthcare Co., Ltd.

8mm Monopolar Curved Scissors

Intuitive Surgical, Inc.

Bio-Medicus Life Support Catheter and Introducer

Medtronic, Inc.

CaRi-Plaque

Caristo Diagnostics , Ltd.

Flowflex COVID-19 Antigen Home Test

ACON Laboratories, Inc.

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