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
152305–152328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1984
FOSTER 757 SCAVENGER
K841507 · CBN
Colson Equipment, Inc.
Anesthesiology · 64d
Cleared Jun 14, 1984
BLOOD GAS CONTROL, LEVEL I(ACIDOSIS
K841783 · JJS
Bionostics, Inc.
Chemistry · 45d
Cleared Jun 14, 1984
VARIAN 2000 LIQUID CHROMATOGRAPHY ANALY
K841890 · KZR
Varian Assoc., Inc.
Toxicology · 38d
Cleared Jun 14, 1984
FRASER HARLAKE EMERG. CARE SUCTION SYS
K841903 · BTA
Fraser Harlake, Inc.
General & Plastic Surgery · 38d
Cleared Jun 14, 1984
SIGMS PROCED. 228 UV LACTATE DEHYDRO
K841917 · CFJ
Sigma Diagnostics, Inc.
Chemistry · 36d
Cleared Jun 14, 1984
SIGMA PROCED. 245 ALKALINE PHOSPHATASE
K841918 · CJE
Sigma Diagnostics, Inc.
Chemistry · 36d
Cleared Jun 14, 1984
MWI 888 & 666 DOUBLE LUMEN SUBCLAVIAN
K842342
Med-West, Inc.
Gastroenterology & Urology
Cleared Jun 13, 1984
ORTHO* SERUM ELISA TEST SYSTEM
K833636 · DAK
Ortho Diagnostic Systems, Inc.
Immunology · 240d
Cleared Jun 13, 1984
SILVERTORQUE CARDIAC CATHETERS
K840763 · DQO
Surgimed Corp.
Cardiovascular · 111d
Cleared Jun 13, 1984
CRAFTMATIC ELECTRIC ADJUSTABLE BED
K840787 · LLI
Contour, Inc.
General Hospital · 145d
Cleared Jun 13, 1984
CENTRAL VENOUS ACCESS CATHETER CVAC-XX
K841587 · DQY
Gish Biomedical, Inc.
Cardiovascular · 107d
Cleared Jun 13, 1984
IMMU-TEC
K841862 · DCK
Medilab Corp.
Immunology · 40d
Cleared Jun 13, 1984
MONO-TEC
K841863 · KTN
Medilab Corp.
Immunology · 40d
Cleared Jun 11, 1984
CARDIOSEARCH RIGHT ATRIAL CATH-
K833873 · DQY
Cardio Search, Inc.
Cardiovascular · 216d
Cleared Jun 11, 1984
HEPARINOMETER
K834024 · KFF
Western Laboratories Corp.
Chemistry · 202d
Cleared Jun 11, 1984
ANGIOSCOPY CATHETER
K834547 · LYK
American Edwards Laboratories
Cardiovascular · 167d
Cleared Jun 11, 1984
SUCTION DEVICE-PHARYNEAL DEVICE
K840669 · JOL
Lipsky-Dale Medical Products
General Hospital · 132d
Cleared Jun 11, 1984
SILVERTORQUE VISCERAL CATHETER
K840761 · DQY
Surgimed Corp.
Cardiovascular · 109d
Cleared Jun 11, 1984
PORTA PAK 90
K840900 · LDD
Medical Research Laboratories, Inc.
Cardiovascular · 104d
Cleared Jun 11, 1984
SCANLAN COLORMARK SKIN MARKER
K841085 · FZZ
Scanlan Intl., Inc.
General & Plastic Surgery · 90d
Cleared Jun 11, 1984
DESERET HEPARIN COATED FLOW CATH
K841251 · DYG
Parke-Davis Co.
Cardiovascular · 77d
Cleared Jun 11, 1984
TUBE TENDER
K841296 · KRI
The Anspach Effort, Inc.
Cardiovascular · 73d
Cleared Jun 11, 1984
DESERET HEPARIN COATED FLOW DIRECTED
K841317 · DYG
Parke-Davis Co.
Cardiovascular · 70d
Cleared Jun 11, 1984
TEMPERATURE CONTROL & MONITOR
K841402 · DWC
Sams, Inc.
Cardiovascular · 69d