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
170833–170856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1978
DIGITAL IMAGE MEMORY/PROCESSOR
K781056
Quantex Corp.
Radiology · 52d
Cleared Aug 14, 1978
CUTTER/COMPUR MINI CENTRIFUGE
K781059 · GKF
Cutter Laboratories, Inc.
Hematology · 49d
Cleared Aug 14, 1978
MONOJECT ENDOSSEOUS DENTAL IMPLANT
K781060 · DZE
Sherwood Medical Industries
Dental · 49d
Cleared Aug 14, 1978
DROPPERS, SOLUTION, IODINE
K781061 · JTS
Marion Laboratories, Inc.
Chemistry · 49d
Cleared Aug 14, 1978
DROPPER, SOLUTION TRICHROME, CEPTI-SEAL
K781062 · HYW
Marion Laboratories, Inc.
Chemistry · 49d
Cleared Aug 14, 1978
T3 STANDARDS IN HUMAN SERUM
K781069 · JIT
Pcl-Ria, Inc.
Chemistry · 49d
Cleared Aug 14, 1978
STANDARDS, HORMONE, THYROID STIMULATING
K781071 · JIT
Pcl-Ria, Inc.
Chemistry · 49d
Cleared Aug 14, 1978
STATTEK-GLUCOSE LOW LEVEL
K781075 · CGA
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Aug 14, 1978
CHEMISTRY ANALYZER
K781076 · JJE
Johns Scientific, Inc.
Chemistry · 47d
Cleared Aug 14, 1978
INSULIN AUTOPAK
K781086 · CFP
Micromedic Systems
Toxicology · 46d
Cleared Aug 14, 1978
HDL CENTRIFIKIT
K781093 · LBR
Beckman Instruments, Inc.
Chemistry · 45d
Cleared Aug 14, 1978
INOCULUM STDIZING SYS., INOCUPAC
K781097
3M Company
Microbiology · 42d
Cleared Aug 14, 1978
SURGICAL GOWNS AND DRAPES
K781099 · FYA
Convertors
General Hospital · 42d
Cleared Aug 14, 1978
DELTA TEST AMYLASE/LIPASE CONTS. I,II
K781100 · JJT
Bd Becton Dickinson Vacutainer...
Chemistry · 42d
Cleared Aug 14, 1978
ULTRAMATE 990
K781114 · EIA
Litton Dental Products
Dental · 42d
Cleared Aug 14, 1978
ECA HEME BUFFER
K781119 · JBD
Electrophoresis Corp. of America
Chemistry · 42d
Cleared Aug 14, 1978
HEMOLYSE
K781121 · GGK
Electrophoresis Corp. of America
Hematology · 42d
Cleared Aug 14, 1978
PC-CALIBRATOR
K781133 · KRY
Streck Laboratories, Inc.
Hematology · 39d
Cleared Aug 14, 1978
INGROWN TOENAIL APPLIANCE, OR
K781135
Barmore, Barbara
Orthopedic · 38d
Cleared Aug 14, 1978
SPECTROPHOTOMETER
K781138 · JJQ
Bausch & Lomb, Inc.
Chemistry · 39d
Cleared Aug 14, 1978
IMMUNOFLUORESCENCE TEST KIT
K781143
Microbiological Assoc.
Immunology · 35d
Cleared Aug 14, 1978
CPK-L TUBE
K781149 · CGS
Bd Becton Dickinson Vacutainer...
Chemistry · 34d
Cleared Aug 14, 1978
QUANTIMUNE HTSH IRMA HUMAN THYROID
K781170 · JLW
Bio-Rad
Immunology · 31d
Cleared Aug 14, 1978
CLINIRIA T-3 UPTAKE TEST
K781180 · KHQ
Miles Laboratories, Inc.
Chemistry · 31d