Search FDA 510(k) Devices

5,449 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
1417–1440 of 3,347
Cleared Aug 10, 2023
GEM Premier 7000 with IQM3
K223608 · CHL
Instrumentation Laboratory Company
Chemistry · 251d
Cleared Aug 10, 2023
SuperBall Meniscal Repair System
K223500 · GAT
Arcuro Medical , Ltd.
General & Plastic Surgery · 262d
Cleared Aug 10, 2023
ArtiFascia
K223445 · GXQ
Nurami Medical , Ltd.
Neurology · 269d
Cleared Aug 10, 2023
HAVAb IgG II
K222850 · LOL
Abbott Laboratories
Microbiology · 323d
Cleared Aug 10, 2023
ID NOW COVID-19 2.0
K221925 · QWR
Abbott Diagnostics Scarborough, Inc.
Microbiology · 405d
Cleared Aug 10, 2023
Accu-Chek Solo micropump system with interoperable technology
K213134 · QFG
Roche Diabetes Care GmbH
Chemistry · 682d
Cleared Aug 10, 2023
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
K213131 · NBW
Roche Diabetes Care GmbH
Chemistry · 682d
Cleared Aug 09, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K232039 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 30d
Cleared Aug 09, 2023
Medline UNITE® REFLEX® Nitinol Staple System
K231885 · JDR
Medline Industries, LP
Orthopedic · 43d
Cleared Aug 09, 2023
VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
K231525 · NIG
Ortho-Clinical Diagnostics
Immunology · 75d
Cleared Aug 09, 2023
Intense Pulsed Light System
K231394 · ONF
Smedtrum Medical Technology Co., Ltd.
General & Plastic Surgery · 86d
Cleared Aug 09, 2023
Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles,...
K231376 · MBI
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Aug 09, 2023
Conductive Silicone Rubber Electrode
K231167 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 106d
Cleared Aug 09, 2023
Conductive carbon film electrode
K231164 · GXY
Guangzhou Xinbo Electronic Co., Ltd.
Neurology · 106d
Cleared Aug 09, 2023
Zimmer® Natural Nail® System Cephalomedullary Nails
K231114 · HSB
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 112d
Cleared Aug 09, 2023
Polyisoprene Surgical Gloves
K230304 · KGO
Puyang Linshi Medical Supplies Co., Ltd.
General Hospital · 187d
Cleared Aug 09, 2023
Air Smart Extra Spirometer
K222443 · BZG
Feellife Health, Inc.
Anesthesiology · 362d
Cleared Aug 08, 2023
Efai Pacs Picture Archiving and Communication System Pro
K232100 · LLZ
Ever Fortune.Ai, Co., Ltd.
Radiology · 25d
Cleared Aug 08, 2023
Ceribell Instant EEG Headband
K232052 · GXY
Ceribell, Inc.
Neurology · 29d
Cleared Aug 08, 2023
Disposable Medical Examination Nitrile Gloves
K232008 · LZA
Raxwell Industrial, LLC
General Hospital · 33d
Cleared Aug 08, 2023
Arthrex TightRope II
K231857 · MBI
Arthrex, Inc.
Orthopedic · 46d
Cleared Aug 08, 2023
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
K230620 · DQO
Gentuity, LLC
Cardiovascular · 155d
Cleared Aug 08, 2023
Visual-ICE Cryoablation System
K230551 · GEH
Boston Scientific Corporation
Orthopedic · 161d
Cleared Aug 08, 2023
LW Implant System
K223924 · DZE
Ossvis Co., Ltd.
Dental · 221d