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
172177–172200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 1977
IN VITRO PHENOBARBITAL RIA TEST
K772111 · DKP
Clinical Assays, Inc.
Immunology · 21d
Cleared Nov 28, 1977
OCULAR CEREBRAL VASCULAR MONITOR
K772130 · HKY
Digilab, Inc.
Ophthalmic · 17d
Cleared Nov 28, 1977
URINE SPECIMEN COLLECTING DEVICE
K772133 · FCN
Kendall Research Center
Gastroenterology & Urology · 14d
Cleared Nov 28, 1977
SYRINGE, IRRIGATION, PRE-FILLED
K772134 · KOA
Kendall Research Center
Gastroenterology & Urology · 14d
Cleared Nov 28, 1977
CATHETER, DISP., EXTERNAL, MALE
K772144 · EXJ
Medline Industries, Inc.
Gastroenterology & Urology · 13d
Cleared Nov 28, 1977
GW 35 GUIDE WIRE
K772147 · FIF
Sorensen Research
Hematology · 14d
Cleared Nov 28, 1977
DIALYSIS DRAINAGE UNIT, PERITONEAL
K772150 · FKX
C.R. Bard, Inc.
Gastroenterology & Urology · 14d
Cleared Nov 28, 1977
CENTRAL MONITORING SYSTEM
K772152 · DXG
Burdick Corp.
Cardiovascular · 13d
Cleared Nov 28, 1977
ELECTROSURGICAL GROUNDING PAD
K772160 · JOS
Ndm Corp.
General & Plastic Surgery · 12d
Cleared Nov 28, 1977
DIALYSIS MACHINES DM-346 & 346-1
K772163 · FIJ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 12d
Cleared Nov 28, 1977
SPECTROPHOTOMETER - SERIES AA-575
K772165 · JXR
Varian Assoc., Inc.
Toxicology · 12d
Cleared Nov 28, 1977
CATHETER SYSTEM, COPE/EISENBERG
K772175 · DQO
Victory Engineering Corp.
Radiology · 7d
Cleared Nov 23, 1977
CTR 100L
K771978 · JAK
Emi Medical, Inc.
Radiology · 37d
Cleared Nov 23, 1977
MYOTONE EMG MONITOR
K772005 · IKN
Micro Tronics Corp.
Neurology · 33d
Cleared Nov 23, 1977
BETA-HCG RIA
K772039 · JHI
Monitor Science Corp.
Immunology · 26d
Cleared Nov 23, 1977
INTUBATION PROCEDURE KIT
K772046 · BSR
American Hospital Supply Corp.
Anesthesiology · 26d
Cleared Nov 23, 1977
RESPIRATORY KIT
K772047 · CAH
American Hospital Supply Corp.
General Hospital · 26d
Cleared Nov 23, 1977
QUANTROLS HCG
K772086 · JHI
Organon, Inc.
Chemistry · 20d
Cleared Nov 22, 1977
UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS
K771102 · LFR
The Dow Chemical Co.
Chemistry · 155d
Cleared Nov 22, 1977
PRESSURE MONITOR MANOMETRIC SYS.
K771265 · KLA
Physio-Control Corp.
Gastroenterology & Urology · 132d
Cleared Nov 22, 1977
LATELET RETENTION COLUMN
K771523 · JBZ
Bd Becton Dickinson Vacutainer...
Hematology · 106d
Cleared Nov 22, 1977
THROMBO-SCREEN PLATELET ADHESION
K771678 · JBZ
Bay Area Hema. Onco. Clinic. & Res. L
Hematology · 81d
Cleared Nov 22, 1977
HILL TUBE
K771723 · KLA
Physio-Control Corp.
Gastroenterology & Urology · 70d
Cleared Nov 22, 1977
EVOKED RESPONSE SYS., MODEL 10
K771742 · GWK
Grass Instrument Co.
Neurology · 68d