FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
122689–122712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 27, 1991
BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS
K910196 · FGH
C.R. Bard, Inc.
Gastroenterology & Urology · 70d
Cleared Mar 27, 1991
X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110
K910308 · ITY
Inmark Corp.
Radiology · 62d
Cleared Mar 27, 1991
SUTURE REMOVAL KIT
K910361 · MCZ
Megadyne Medical Products, Inc.
General & Plastic Surgery · 57d
Cleared Mar 27, 1991
SLT MICROPLATE WASHER
K910740 · JJQ
Tecan U.S., Ltd.
Chemistry · 34d
Cleared Mar 26, 1991
NAMIC CONTRAST SAVINGS DELIVERY SYSTEM
K903493 · IZI
North American Instrument Corp.
Radiology · 235d
Cleared Mar 26, 1991
DEVILBISS MODEL 7352 SERIES
K904766 · BZD
Devilbiss Health Care, Inc.
Anesthesiology · 155d
Cleared Mar 26, 1991
L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC
K904901 · ITX
Parexel Intl. Corp.
Radiology · 147d
Cleared Mar 26, 1991
SMA 26 TRANSDUCER
K904902 · ITX
Parexel Intl. Corp.
Radiology · 147d
Cleared Mar 26, 1991
JETTA JR. HYDRO MASSAGE
K905599 · ILJ
Jetta Products, Inc.
Physical Medicine · 103d
Cleared Mar 26, 1991
ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)
K905785 · HRX
Orthoconcept, Inc.
Orthopedic · 97d