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
147817–147840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 1985
VENUOS RESERVOIR BAG BMR-1900
K851401 · DTN
American Bentley
Cardiovascular · 77d
Cleared Jun 25, 1985
CK/LD ISOENZYMES CONTROLS(HUMAN)
K851520 · JJT
Seragen Diagnostics, Inc.
Chemistry · 71d
Cleared Jun 25, 1985
ELECTROLYTE ANALYZER
K851808 · CEM
Ionetics, Inc.
Chemistry · 71d
Cleared Jun 25, 1985
TANDEM E PAP
K851950 · JFH
Hybritech, Inc.
Chemistry · 53d
Cleared Jun 25, 1985
INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU
K851990 · JIX
Alpkem Corp.
Chemistry · 49d
Cleared Jun 25, 1985
CA BUFFER CA DYE
K852002 · CIC
Alpkem Corp.
Chemistry · 49d
Cleared Jun 25, 1985
MG REAGENT
K852005 · JGJ
Alpkem Corp.
Chemistry · 49d
Cleared Jun 25, 1985
PREGNANCY CARD TEST
K852066 · JHJ
Em Diagnostic Systems, Inc.
Chemistry · 46d
Cleared Jun 25, 1985
BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA
K852158 · LCQ
Bioprobe Intl., Inc.
Toxicology · 39d
Cleared Jun 25, 1985
ASSIST CLINICAL CHEMISTRY ANALYZER
K852262 · JJE
Cooper Biomedical, Inc.
Chemistry · 32d
Cleared Jun 25, 1985
TIPSEP DIGOXIN RIA
K852291 · DNL
Nuclear Diagnostics, Inc.
Toxicology · 27d
Cleared Jun 25, 1985
COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
K852317 · KLQ
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jun 25, 1985
COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
K852318 · LFT
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jun 25, 1985
COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS
K852319 · LAN
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jun 24, 1985
OMS SILICONE OIL INJECTOR
K844895 · LWL
Optical Micro Systems, Inc.
Ophthalmic · 189d
Cleared Jun 24, 1985
COROMETRICS 500 INFANT MONITOR
K850504 · BZQ
Ge Medical Systems Information...
Anesthesiology · 136d
Cleared Jun 24, 1985
LASERFLO BLOOD PERFUSION MONITOR 403
K851057 · DPW
Tsi, Inc.
Cardiovascular · 102d
Cleared Jun 24, 1985
MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR
K851152 · DWS
Cryomedics, Inc.
Cardiovascular · 95d
Cleared Jun 24, 1985
ELECTRA 800 AUTOMATIC COAGULATION TIMER
K851169 · KQG
Medical Laboratory Automation...
Pathology · 94d
Cleared Jun 24, 1985
PAPILLOTOME
K851652 · KNS
Microvasive
Gastroenterology & Urology · 63d
Cleared Jun 24, 1985
SAFESEAL REUSABLE URINAL SYSTEM
K851682 · EXJ
Dbt Medical , Ltd.
Gastroenterology & Urology · 62d
Cleared Jun 24, 1985
STOMAHESIVE SKIN BARRIER STERILE
K851840 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 59d
Cleared Jun 24, 1985
MEDICAL TOILET SEAT
K852049 · ILS
Pedro Aleman
Physical Medicine · 47d
Cleared Jun 24, 1985
DEVO/MC29 OXYGEN CONCENTRATOR MC29D
K852209 · CAW
The Devilbiss Co.
Anesthesiology · 34d