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
122089–122112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1991
CLAW (5MM/10MM) ATRAUMATIC GRASP/MICRO FORCEPS
K911180 · HTD
Northgate Technologies, Inc.
General & Plastic Surgery · 11d
Cleared Mar 29, 1991
YOURS TRULY ASYMMETRICAL BREAST FORM
K911247 · KCZ
Jobst Institute, Inc.
General & Plastic Surgery · 8d
Cleared Mar 28, 1991
SWIRL PROPHYLAXIS PASTE
K903986 · EJR
Bio-Medica Concepts
Dental · 211d
Cleared Mar 28, 1991
TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM
K905708 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 97d
Cleared Mar 28, 1991
MEGA DRESSING CHANGE KIT
K910363 · MCY
Megadyne Medical Products, Inc.
General & Plastic Surgery · 58d
Cleared Mar 28, 1991
WOUND CLOSURE KIT
K910365 · LRO
Megadyne Medical Products, Inc.
General & Plastic Surgery · 58d
Cleared Mar 28, 1991
MEGA GENERAL PURPOSE INSTRUMENT KIT
K910366 · KDD
Megadyne Medical Products, Inc.
General & Plastic Surgery · 58d
Cleared Mar 28, 1991
INCISION AND DRAINAGE KIT
K910369 · KDD
Megadyne Medical Products, Inc.
General & Plastic Surgery · 58d
Cleared Mar 28, 1991
AVD INTIMAX CHOLANGIOGRAPHY CATHETER
K910493 · FGE
Applied Vascular Devices, Inc.
Gastroenterology & Urology · 51d
Cleared Mar 28, 1991
SURGICAL CLIPPER
K910524 · LWK
Baxter Healthcare Corp
General & Plastic Surgery · 49d
Cleared Mar 28, 1991
COMBINED MALAR IMPLANT
K910655 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 42d
Cleared Mar 28, 1991
SURGICAL TISSUE POUCH
K910914 · KGY
Cook Urological, Inc.
General & Plastic Surgery · 23d
Cleared Mar 27, 1991
MP4, MP4SI, IT4 INCUBATORS
K901157 · FMZ
Mediprema
General Hospital · 379d
Cleared Mar 27, 1991
MC II (TM), MODEL 7200S
K903161 · GZJ
Medical Devices, Inc.
Neurology · 252d
Cleared Mar 27, 1991
MINI-MICRON CIRCUIT
K903499 · CAF
Medical Industries America, Inc.
Anesthesiology · 236d
Cleared Mar 27, 1991
CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
K904189 · LJC
Ciba Corning Diagnostics Corp.
Microbiology · 196d
Cleared Mar 27, 1991
STRUNG TELFA NON-ADHERENT SPONGE
K904514 · HBA
American Silk Sutures, Inc.
Neurology · 176d
Cleared Mar 27, 1991
CHF-B20 CHOLEDOCHOSCOPE
K904799 · FBN
Olympus Corp.
Gastroenterology & Urology · 154d
Cleared Mar 27, 1991
SIF-SW
K904800 · FDA
Olympus Corp.
Gastroenterology & Urology · 154d
Cleared Mar 27, 1991
G-TUBE DRESSING CHANGE TRAY
K905123 · MCY
Continental Medical Laboratories, Inc.
General & Plastic Surgery · 133d
Cleared Mar 27, 1991
THORA-KLEX CHEST DRAINAGE UNIT
K905448 · GCX
Davol, Inc.
General Hospital · 112d
Cleared Mar 27, 1991
OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY
K905646 · LJT
Norfolk Medical
General Hospital · 100d
Cleared Mar 27, 1991
POST SURGICAL KIT/POST BIOPSY KIT
K910011 · MCY
Dermatological Research Laboratories,...
General & Plastic Surgery · 84d
Cleared Mar 27, 1991
ORTHOCONCEPT ARTHROSCOPIC PUMP
K910164 · HRX
Orthoconcept, Inc.
Orthopedic · 71d