FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
9577–9600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 2023
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
K230428 · EOQ
Ambu A/S
Ear, Nose, Throat · 174d
Cleared Aug 10, 2023
ZenPro 40
K230268 · GEX
BLUECORE COMPANY Co., Ltd.
General & Plastic Surgery · 191d
Cleared Aug 10, 2023
ANNE One
K223711 · DRG
Sibel Health, Inc.
Cardiovascular · 241d
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