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

Infrared thermometer

Shenzhen Yolanda Technology Co., Ltd.

Medispine - Spinal Needle, Glospine - Spinal Needle

Global Medikit Limited

ME-APDS™; MAGENTIQ-COLO™

Magentiq Eye, Ltd.

miCOR System Lens Fragmentation System

Carl Zeiss Meditec Cataract Technology, Inc.

SimplGuide

Pendracare

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal

Prevest Denpro Limited

Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP

Shenzhen Root Innovation Technology Co., Ltd.

Hemosure Accu-Reader A100

W.H.P.M., Inc.

Artix Ballon Guiding Sheath

Inari Medical

Sterile High-pressure Angiographic Syringes for Single-use

Shenzhen Boon Medical Supply Co., Ltd.

FINDER Flu A&B/SARS-CoV-2 Test

Baebies, Inc.

Riva Cem Automix

Sdi Limited

Mpact Constrained Liner

Medacta International S.A.

ATLAAS (Atraumatic Left Atrial Appendage System) (AD)

Genesee Biomedical, Inc.

Cardio10

Bionet Co., Ltd.

IPL Hair Removal Device

Shenzhen Noble Smart Manufacturing Tech Co., Ltd.

FiteBac CC OrthoSeal

Largent Health, LLC

Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter

Zhejiang Curaway Medical Technology Co., Ltd.

Neodent Implant System – Custom Abutments

JJGC Indústria e Comércio de Materiais Dentários S.A.

Sparrow Ascent

Spark Biomedical, Inc.

Aptiva APS IgA Reagent

Inova Diagnostics, Inc.

Fixtemp® C&B 4:1

Dreve Denatmid GmbH

MSKai

Mskai

BELLUS-Q

Speclipse, Inc.

VEOS Spinal Fixation System

Spineway

Catalyst R1 Reverse Shoulder System

Catalyst Orthoscience, Inc.

UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniC

Beckman Coulter, Inc.

Self-Seal Sterilization Pouch and Roll

Guangdong Maidi Medical Co., Ltd.

InnoClip Disposable Clip Applier, InnoClip Clip Applier

Taiwan Surgical Corporation

RXS 1000

Rolence Enterprise, Inc.

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