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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
85177–85200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1999
TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
K992122 · LYZ
Maxxim Medical
General Hospital · 22d
Cleared Jul 14, 1999
NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+...
K980380 · GWM
Diametrics Medical, Ltd.
Neurology · 527d
Cleared Jul 14, 1999
EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
K983660 · LHN
Brainlab, Inc.
Radiology · 268d
Cleared Jul 14, 1999
THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K984563 · IWB
Accuray, Inc.
Radiology · 203d
Cleared Jul 14, 1999
SOLAR 9500 INFORMATION MONITOR
K990068 · MHX
General Electric Medical Systems...
Cardiovascular · 187d
Cleared Jul 14, 1999
ELECTRO MECHANICAL LITHOTRIPTOR
K990341 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 161d
Cleared Jul 14, 1999
INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI...
K990847 · MQH
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 121d
Cleared Jul 14, 1999
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52,...
K990941 · MQK
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 114d
Cleared Jul 14, 1999
REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
K991114 · DZE
Lifecore Biomedical, Inc.
Dental · 104d
Cleared Jul 14, 1999
STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
K991291 · GEI
Conway Stuart Medical, Inc.
General & Plastic Surgery · 90d
Cleared Jul 14, 1999
BOVINE SERUM ALBUMIN (BSA)
K991338 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 86d
Cleared Jul 14, 1999
PVP (POLYVINYLPYRROLIDONE)
K991343 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 86d
Cleared Jul 14, 1999
SPIN SNAP-OFF SCREW
K991477 · HWC
New Deal, S.A.
Orthopedic · 77d
Cleared Jul 14, 1999
SMITH & NEPHEW SUTURE LOK
K991500 · OCW
Smith & Nephew Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Jul 14, 1999
PRO-PORTION CLEANER/DISINFECTANT
K991509 · LRJ
Sultan Chemists, Inc.
General Hospital · 75d
Cleared Jul 14, 1999
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
K991567 · FTM
Shelhigh, Inc.
General & Plastic Surgery · 70d
Cleared Jul 14, 1999
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING...
K991616 · LYY
Hartalega Sdn Bhd
General Hospital · 65d
Cleared Jul 14, 1999
26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER
K991622 · JDI
Stelkast Company
Orthopedic · 64d
Cleared Jul 14, 1999
DEPUY ROCKWOOD CLAVICLE PIN
K991649 · JDW
Depuy, Inc.
Orthopedic · 62d
Cleared Jul 14, 1999
COBREX HIP STEM, MODEL 01-128-XXXXX
K991869 · JDI
Implex Corp.
Orthopedic · 43d
Cleared Jul 14, 1999
REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
K992151 · LAS
Consolidated Technologies, Inc.
Toxicology · 20d
Cleared Jul 13, 1999
ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
K972772 · MJA
Trek Diagnostic Systems, Inc.
Microbiology · 719d
Cleared Jul 13, 1999
SCLERAL PLUGS, 19 AND 20 GAUGE
K990872 · LXP
Ophthalmic Consultants, Inc.
Ophthalmic · 119d
Cleared Jul 13, 1999
AHMED GLAUCOMA VALVE IMPLANT
K991072 · KYF
New World Medical, Inc.
Ophthalmic · 104d