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
152617–152640 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1984
ACUFEX SHOULDER HOLDER
K841388 · HST
Acufex Microsurgical, Inc.
Neurology · 43d
Cleared May 16, 1984
POTASSIUM CHLORIDE SOLUTION -2 MOLAR
K841417 · JGS
Reagent Laboratory, Inc.
Chemistry · 41d
Cleared May 16, 1984
SODIUM ELECTRODE RINSE SOLUTION 2
K841418 · JGS
Reagent Laboratory, Inc.
Chemistry · 41d
Cleared May 16, 1984
CORNING LACTATE DEHYDROPHORETIC ASSAY
K841433 · CFE
Corning Medical & Scientific
Chemistry · 40d
Cleared May 16, 1984
COMA TOXICOLOGY CONTROL
K841439 · DIF
American Dade
Toxicology · 40d
Cleared May 16, 1984
TOTAL PROTEIN REAGENT BIURET
K841466 · CEK
Reagents Applications, Inc.
Chemistry · 37d
Cleared May 16, 1984
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K841471 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 37d
Cleared May 16, 1984
DIRECT BILIRUBIN REAGENT
K841572 · CIG
Hi Chem, Inc.
Chemistry · 29d
Cleared May 16, 1984
INSULIN RADIOIMMUNOASSAY KIT
K841573 · CFP
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 29d
Cleared May 16, 1984
SUN BEDS
K841614 · FTC
Sunworld Corp.
General & Plastic Surgery · 75d
Cleared May 16, 1984
DUPONT THEOPHYLLINE DIT CALIBRATOR
K841655 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 23d
Cleared May 16, 1984
7200 MICROPROCESSOR VENTILATOR
K841757 · CBK
Puritan Bennett Corp.
Anesthesiology · 19d
Cleared May 16, 1984
STROLLER SPRINT
K841808 · BYJ
Cryogenic Assoc.
Anesthesiology · 15d
Cleared May 14, 1984
SPHYGOMANO METER
K833799 · DXN
Fraser Harlake, Inc.
Cardiovascular · 195d
Cleared May 14, 1984
ORTHO ENZYME IMMUNOASSAY HOME PREG.TEST
K834270 · LCX
Advanced Care Products
Chemistry · 158d
Cleared May 14, 1984
YD STRIP GP U20
K834386 · JIL
Yd Pharmaceutical Corp.
Chemistry · 152d
Cleared May 14, 1984
YD STRIP GPH U21
K834387 · JIL
Yd Pharmaceutical Corp.
Chemistry · 152d
Cleared May 14, 1984
SCRATCH & SNIFF FOR ANESTHESIA
K840431 · CAI
Dryden Corp.
Anesthesiology · 103d
Cleared May 14, 1984
FEMORAL CEMENT REMOVAL INSTRUMENT
K840735 · HWX
Amtech Scientific, Inc.
Orthopedic · 83d
Cleared May 14, 1984
KYOTEST 5V
K840827 · CEN
Kyoto Diagnostics, Inc.
Chemistry · 80d
Cleared May 14, 1984
KYOTEST 8V
K840828 · JMT
Kyoto Diagnostics, Inc.
Hematology · 80d
Cleared May 14, 1984
CHESTAC-25F SPIROMETER
K840908 · BZG
Medical Equipment Designs, Inc.
Anesthesiology · 75d
Cleared May 14, 1984
FRC 85 SERIES SPIROMETER
K840929 · BZG
Medical Equipment Designs, Inc.
Anesthesiology · 73d
Cleared May 14, 1984
ANESTHETIC GAS MONITOR SYS
K840966 · CCK
Marquest Medical Products, Inc.
Anesthesiology · 69d