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
149473–149496 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1985
DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/GLUCOSE A
K850092 · KIT
Sigma Chemical Co.
Pathology · 47d
Cleared Feb 27, 1985
CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS
K850157 · KPA
Shaban Mfg. Co.
Hematology · 43d
Cleared Feb 27, 1985
QUICK-LYTE
K850209 · JGS
Seragen Diagnostics, Inc.
Chemistry · 40d
Cleared Feb 27, 1985
GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER
K850260 · JQT
Gelman Sciences, Inc.
Chemistry · 36d
Cleared Feb 27, 1985
SPARCO PIGGY-BACK POLE-INTRAVENOUS TRANSPORT POLE
K850267
Sparco, Inc.
General & Plastic Surgery · 35d
Cleared Feb 27, 1985
PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS
K850333 · KPA
Shaban Mfg. Co.
Hematology · 30d
Cleared Feb 27, 1985
PRUITT-VASCULAR SHUNTS
K850356 · DWF
Ideas For Medicine, Inc.
Cardiovascular · 28d
Cleared Feb 27, 1985
ROCHE STANDARDS FOR CHLORIDE & CO2
K850396 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Feb 27, 1985
EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA
K850511 · KIT
Mediatech, Inc.
Pathology · 19d
Cleared Feb 27, 1985
DMEM-DULBECCO'S MINIMUM ESSENTIAL MEDIUM
K850512 · KIT
Mediatech, Inc.
Pathology · 19d
Cleared Feb 27, 1985
RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640
K850513 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
ALPHA MEM-ALPHA MINIMUM ESSENTIAL MED. W/O RIBOSID
K850514 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
HAM'S F-10-A SPEC. FORMULATION FROM DR. HAM
K850515 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
HAM'S F-12-A SPEDIFIC FORMULATION FORM DR. HAM
K850516 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
MED. 199 W/EARLE'S SALTS-MEDIUM 199 W/EARLES SALTS
K850517 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
NA PYRUVATE-SODIUM PYRUVATE
K850518 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
GLUTAMINE-1-GLUTAMINE
K850519 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
NEAA-NON-ESSENTIAL AMINO ACIDS
K850520 · KIT
Mediatech, Inc.
Pathology · 19d
Cleared Feb 27, 1985
MEM AA-MINIMUM ESSENTIAL MEDIUM AMINO ACIDS
K850521 · KIT
Mediatech, Inc.
Pathology · 19d
Cleared Feb 27, 1985
MEM VITAMINS-MINIMUM ESSENTIAL MEDIUM VITAMINS
K850522 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
EBSS-EARLE'S BALANCE SALT SOLUTION
K850523 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
HBSS-HANKS' BALANCED SALT SOLUTION
K850524 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE
K850525 · KIT
Mediatech, Inc.
Microbiology · 19d
Cleared Feb 27, 1985
EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION
K850526 · KIT
Mediatech, Inc.
Microbiology · 19d