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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