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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
107569–107592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1994
AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE
K941603 · KYB
Allergan Medical Optics
Ophthalmic · 96d
Cleared Jul 06, 1994
EMC MODEL NO. 322870 ENDOSTAT
K941721 · GEI
Emc Industries
General & Plastic Surgery · 90d
Cleared Jul 06, 1994
BODYWISE PREGNANCEY TEST
K941771 · LCX
Charlton Assoc.
Chemistry · 86d
Cleared Jul 06, 1994
SUNGLASSES
K941785 · HQY
K. L. Wings Co., Ltd.
Ophthalmic · 86d
Cleared Jul 06, 1994
V-PRIMER
K942017 · KLE
Parkell, Inc.
Dental · 71d
Cleared Jul 06, 1994
INFLUENZA A ANTIGEN TEST
K942172 · GNW
Neogenex
Microbiology · 62d
Cleared Jul 06, 1994
MEGABEAM DENTAL FIBER
K942182 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 63d
Cleared Jul 06, 1994
PURITAN-BENNETT NASAL CPAP MASK
K942246 · BYE
Puritan-Bennett
Anesthesiology · 58d
Cleared Jul 06, 1994
LAPAROSCOPIC SCISSORS (DISPOSABLE)
K942607 · GEI
O.R. Specialties, Inc.
General & Plastic Surgery · 35d
Cleared Jul 06, 1994
STERI-LUBE
K942672 · EFB
Petroleum Products of America
Dental · 30d
Cleared Jul 06, 1994
CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE
K942736 · DTJ
Carbomedics, Inc.
Cardiovascular · 26d
Cleared Jul 05, 1994
ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES
K911884 · DTL
Advance Medical Designs, Inc.
Cardiovascular · 1163d
Cleared Jul 05, 1994
AMD DENTIST AND HYGIENIST KITS
K925115 · EKJ
Advance Medical Designs, Inc.
Dental · 634d
Cleared Jul 05, 1994
STERILE BARRIER SLEEVE AND COVER
K930552 · MMP
Patient Safety Products, Inc.
General Hospital · 517d
Cleared Jul 05, 1994
NORMED TITANIUM MINIPLATE SYSTEM
K931539 · JEY
Normed Medizin-Technik GmbH
Dental · 463d
Cleared Jul 05, 1994
U. S. MEDICAL PS-3500 WARMER/INCUBATOR SCALE
K934677 · FMT
U.S. Medical Corp.
General Hospital · 280d
Cleared Jul 05, 1994
BILIBLANKET PLUS PHOTOTHERAPY SYSTEM
K934946 · LBI
Boc Health Care, Inc.
General Hospital · 260d
Cleared Jul 05, 1994
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF
K935487 · JAK
Shimadzu Corp.
Radiology · 232d
Cleared Jul 05, 1994
DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES
K941770 · KGO
Baxter Healthcare Corp
General Hospital · 85d
Cleared Jul 05, 1994
SDI COMPOSTIES
K941899 · EBF
Southern Dental Industries, Inc.
Dental · 77d
Cleared Jul 05, 1994
MRX-280
K942040 · JAK
Mrx Corp.
Radiology · 68d
Cleared Jul 05, 1994
SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM
K942493 · KLE
3M Company
Dental · 41d
Cleared Jul 05, 1994
CLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICE
K942576 · OCT
White Knight Healthcare
Gastroenterology & Urology · 35d
Cleared Jul 05, 1994
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
K942594 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d