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
153289–153312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 02, 1984
MONITOR 5590- ANALYZER 5595EC
K840565 · CCL
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 54d
Cleared Apr 02, 1984
AMIKACIN REAGENT TEST KIT
K840647 · LDN
Beckman Instruments, Inc.
Immunology · 47d
Cleared Apr 02, 1984
PULMONARY FUNCTION SYS-3000
K840711 · BZC
Med-Science Electronics, Inc.
Anesthesiology · 45d
Cleared Apr 02, 1984
BIOSPAL 3000S
K840811 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 41d
Cleared Apr 02, 1984
BIOSPAL 2400S
K840812 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 41d
Cleared Apr 02, 1984
BIOSPAL 1200S
K840813 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 45d