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
154129–154152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1984
MUELLER HINTON AGAR W/BLOOD & COFACTOR
K841138 · JTZ
Anaerobe Systems
Microbiology · 19d
Cleared Apr 04, 1984
SICKLE HB ASSAY
K841170 · GHM
Isolab, Inc.
Hematology · 16d
Cleared Apr 04, 1984
GENERAL NUTRIENT BROTH
K841203 · JSG
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
NON PROPAGATING TRANSPORT
K841205 · JSM
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
SELECTIVE & NON-DIFFERENTIAL
K841210 · JSJ
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
SINGLE BIOCHEMICAL TEST
K841212 · JSF
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
ANTIMICROBIAL SUSCEPT-CULTURE MEDIA
K841213 · JTZ
Smith River Biologicals
Microbiology · 23d
Cleared Apr 04, 1984
SHOPPED MEAT CARBOHYDRATE
K841219 · JSC
Anaerobe Systems
Microbiology · 13d
Cleared Apr 04, 1984
ANAEROBIC TRANSPORT MEDIUM
K841220 · JSL
Anaerobe Systems
Microbiology · 13d
Cleared Apr 04, 1984
BRAIN HEART INFUSION BROTH
K841221 · JSC
Anaerobe Systems
Microbiology · 13d
Cleared Apr 04, 1984
BACTEROIDES BILE ESCULIN GAR
K841222 · JSI
Anaerobe Systems
Microbiology · 13d
Cleared Apr 04, 1984
INJECTION CAP OR ADAPTOR
K841405
Medcare Disp Products, Inc.
General Hospital
Cleared Apr 03, 1984
ONE-PIECE SHUNT
K834593 · JXG
American Heyer Schulte
Neurology · 96d
Cleared Apr 03, 1984
CANAL AID
K840165 · ESD
Qualitone
Ear, Nose, Throat · 78d
Cleared Apr 03, 1984
MID-STREAM URINE COLLECTION SETS
K840709
Concord Laboratories, Inc.
Gastroenterology & Urology · 46d
Cleared Apr 02, 1984
MULTIPLE
K833259 · HQG
Sun House Products Co.
Ophthalmic · 195d
Cleared Apr 02, 1984
FIBERLAS 100 MEDICAL SYSTEM
K833499 · LNK
Fiberlase U.S.A.
Gastroenterology & Urology · 180d
Cleared Apr 02, 1984
SURGITEK ALL SILICONE INFECTION DOUBJ
K833782 · FAD
Surgitek
Gastroenterology & Urology · 157d
Cleared Apr 02, 1984
FLEXI-FLATE PENILE IMPLANT
K834347 · FAE
Surgitek
Gastroenterology & Urology · 111d
Cleared Apr 02, 1984
PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA
K834358 · FIQ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 111d
Cleared Apr 02, 1984
MC 2002 OSTOMY POUCHES & SKIN FLANGES
K840265 · EXB
Coloplast A/S
Gastroenterology & Urology · 70d
Cleared Apr 02, 1984
FILTRODER FILTERS
K840267 · EXB
Coloplast A/S
Gastroenterology & Urology · 70d
Cleared Apr 02, 1984
MC 2000 OSTOMY POUCHES
K840269 · EXB
Coloplast A/S
Gastroenterology & Urology · 70d
Cleared Apr 02, 1984
RAST ALLERGO SORBENT TEST
K840537 · DHB
Pharmacia, Inc.
Microbiology · 54d