Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
166177–166200 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1980
T4-SQUIBB RIA KIT
K802456 · CDX
E. R. Squibb & Sons, Inc.
Chemistry · 23d
Cleared Oct 31, 1980
ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
K802461 · LCW
Immunotech Corp.
Immunology · 23d
Cleared Oct 31, 1980
MICRO-SURGICAL POWER INSTRUMENT SYSTEM
K802463 · ERL
Spire Medical, Inc.
Ear, Nose, Throat · 22d
Cleared Oct 31, 1980
OREAI-Q-TU TEST
K802464 · KHQ
Organon, Inc.
Chemistry · 22d
Cleared Oct 31, 1980
TSH RADIOIMMUNOASSAY KIT
K802467 · JLW
American Diagnostic Corp.
Chemistry · 22d
Cleared Oct 31, 1980
T3 UPTAKE TEST SYSTEM
K802468 · KHQ
American Diagnostic Corp.
Chemistry · 22d
Cleared Oct 31, 1980
MISTY NEBULIZER
K802477 · CAF
Airlife, Inc.
Anesthesiology · 26d
Cleared Oct 31, 1980
SURGICAL KNIVES & PROBES
K802479 · HXB
Eder Instrument Co, Inc.
Orthopedic · 24d
Cleared Oct 31, 1980
7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH
K802481 · DYG
Waters Assoc., Inc.
Cardiovascular · 24d
Cleared Oct 31, 1980
KEOFEED (R) EASY-FILL ENTERIC FEED BAG
K802482 · KNT
Health Development Corp.
Gastroenterology & Urology · 24d
Cleared Oct 31, 1980
MICRO-SUGICAL POWER INSTRUMENT SYSTEM
K802503 · EQJ
Spire Medical, Inc.
Ear, Nose, Throat · 14d
Cleared Oct 31, 1980
FOLEY CATHETER
K802516 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 16d
Cleared Oct 31, 1980
BASIN PACK
K802538 · FNY
Texas Medical Products, Inc.
General Hospital · 16d
Cleared Oct 31, 1980
COTTRELL 90/90 BACKTRAC
K802555 · HST
Lossing Orthopedic, Inc.
Neurology · 15d
Cleared Oct 31, 1980
SURCAN KNEE HOLDING DEVICE
K802558 · FWZ
Bend Orthopedic & Fracture Clinic
General & Plastic Surgery · 15d
Cleared Oct 31, 1980
HI VOLUME PUMPING CHAMBER
K802561 · JTB
Acacia, Inc.
Microbiology · 15d
Cleared Oct 31, 1980
TRANSETTE SYSTEM/COLLECTION & TRANSP
K802563 · JTW
Inolex Corp./Div of Biomedical
Microbiology · 15d
Cleared Oct 31, 1980
3MP-7 SCANNER RESPIRATORY MONITOR
K802565 · CAP
Bird Products Corp.
Anesthesiology · 14d
Cleared Oct 31, 1980
BETA LACTAMASE REAGENT DISK
K802566 · JTO
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 14d
Cleared Oct 31, 1980
FEEDING TUBES IN SILICONE 5,6,8&10 SIZES
K802585 · KNT
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 11d
Cleared Oct 31, 1980
ARTHROSCOPIC FAT PAD RETRACTOR
K802599 · GAD
The Anspach Effort, Inc.
General & Plastic Surgery · 10d
Cleared Oct 31, 1980
LEG BAG EXTENSION TUBE
K802606 · KNX
Associated Medical Products Co.
Gastroenterology & Urology · 10d
Cleared Oct 31, 1980
EMIT-STM OPIATE ASSAY
K802615 · DJE
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
EMIT-STM BENZODIAZEPINE ASSAY
K802616 · JXM
Syva Co.
Toxicology · 11d