FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

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

Filters: Cleared only ×
175,230 results
125569–125592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1990
OSSEOTITE IRRIGATION UNIT
K901600 · EFS
Collagen Corp.
Dental · 76d
Cleared Jun 21, 1990
ACE WIRE TENSION CLAMP
K901984 · JEC
Buckman Co., Inc.
Orthopedic · 50d
Cleared Jun 21, 1990
PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.
K902268 · ILO
Seabrook Medical Systems, Inc.
Physical Medicine · 31d
Cleared Jun 21, 1990
ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
K902269 · ILO
Seabrook Medical Systems, Inc.
Physical Medicine · 31d
Cleared Jun 21, 1990
MODIFIED QM300 RHEUMATOID FACTOR TEST
K902462 · DHR
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 17d
Cleared Jun 21, 1990
BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902484 · DFH
Beckman Instruments, Inc.
Immunology · 16d
Cleared Jun 21, 1990
BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902485 · DEH
Beckman Instruments, Inc.
Immunology · 16d
Cleared Jun 21, 1990
THE COMPANION NON-ELECTRIC LIFT CHAIR
K902600 · INN
Innovative Medical Engineering, Inc.
Physical Medicine · 9d
Cleared Jun 20, 1990
SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG
K900482 · GWF
Axon Systems, Inc.
Neurology · 139d
Cleared Jun 20, 1990
SPECTACLE FRAME
K900732 · HQZ
Seiko Corp.
Ophthalmic · 124d
Cleared Jun 20, 1990
SUNGLASS, NON-PRESCRIPTION
K900764 · HQY
Seiko Optical Products of America, Inc.
Ophthalmic · 120d
Cleared Jun 20, 1990
ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE
K901134 · KNT
Fresenius Pharma
Gastroenterology & Urology · 100d
Cleared Jun 20, 1990
ASI HEMOSTASIS CATHETER
K901336 · GBM
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 20, 1990
ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.
K901397 · MCC
Gen-Probe, Inc.
Microbiology · 86d
Cleared Jun 20, 1990
CONTINUUM KNEE SYSTEM (CKS)
K901457 · JWH
Techmedica, Inc.
Orthopedic · 84d
Cleared Jun 20, 1990
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4
K901475 · CDX
Baxter Healthcare Corp
Chemistry · 85d
Cleared Jun 20, 1990
MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER
K901481 · GEX
Nidek, Inc.
General & Plastic Surgery · 83d
Cleared Jun 20, 1990
PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE
K901531 · DNP
Pioneering Technologies, Inc.
Toxicology · 90d
Cleared Jun 20, 1990
SUNGLASSES STYLE #(1137)
K901570 · HQY
Zaks Stores, Inc.
Ophthalmic · 78d
Cleared Jun 20, 1990
SUNGLASSES STYLE #(CM-1989)
K901571 · HQY
Zaks Stores, Inc.
Ophthalmic · 78d
Cleared Jun 20, 1990
CANNULATED INTERFERENCE SCREW SYSTEM
K901616 · HWC
Smith & Nephew Dyonics, Inc.
Orthopedic · 75d
Cleared Jun 20, 1990
ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444
K901735 · HRX
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 64d
Cleared Jun 20, 1990
DRYSLIDE, BETA-LACTAMASE
K901784 · JTO
Difco Laboratories, Inc.
Microbiology · 64d
Cleared Jun 20, 1990
MICROMATE 196 MODEL A961960
K901808 · JTC
Packard Instrument Co., Inc.
Microbiology · 61d