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
106969–106992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1994
MINIPACK 3100/3000 MODIFICATION
K934385 · DXN
Pace Tech, Inc.
Cardiovascular · 335d
Cleared Aug 10, 1994
CHILDREN'S SUNGLASSES
K935264 · HQY
Agglo Corp. , Ltd.
Ophthalmic · 281d
Cleared Aug 10, 1994
ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE
K935625 · DYH
Wallace A. Erickson & Co.
Dental · 261d
Cleared Aug 10, 1994
DRUG RECONSTITUTION FILTER DEVICE
K941020 · FMF
Gelman Sciences, Inc.
General Hospital · 160d
Cleared Aug 10, 1994
MICRODONTIC LENS
K941716 · EIA
New Image Industries, Inc.
Dental · 125d
Cleared Aug 10, 1994
OTC DENTURE CLEANSER
K942203 · EFT
Combe, Inc.
Dental · 97d
Cleared Aug 10, 1994
IMAGE FULL POWER EXAMINATION/MINOR SURGERY TABLE
K942486 · FQO
Mdt Corp., Inc.
General & Plastic Surgery · 77d
Cleared Aug 10, 1994
ORTHALGENAT IMPRESSION MATERIAL
K942666 · ELW
Dentauraum, Inc.
Dental · 65d
Cleared Aug 10, 1994
CLEARFIL PHOTO BOND
K943165 · KLE
Kuraray Company, Ltd.
Dental · 40d
Cleared Aug 10, 1994
CLEARFIL LINER BOND SYSTEM
K943166 · KLE
Kuraray Company, Ltd.
Dental · 40d
Cleared Aug 10, 1994
CLEARFIL NEW BOND
K943167 · KLE
Kuraray Company, Ltd.
Dental · 40d
Cleared Aug 10, 1994
CLEARFIL AP-X
K943168 · EBF
Kuraray Company, Ltd.
Dental · 40d
Cleared Aug 10, 1994
CLEARFIL AP-X AND LINER BOND 2
K943169 · EBF
Kuraray Company, Ltd.
Dental · 40d
Cleared Aug 10, 1994
CLEARFIL LINER BOND 2
K943170 · KLE
Kuraray Company, Ltd.
Dental · 40d
Cleared Aug 10, 1994
SPECTACLE FRAMES
K943326 · HQZ
Buffard-La-Doye
Ophthalmic · 30d
Cleared Aug 10, 1994
BIO74-PF CROWN & BRIDGE ALLOY
K943487 · EJT
Jeneric/Pentron, Inc.
Dental · 22d
Cleared Aug 10, 1994
FACONNABLE EYEWEAR
K943567 · HQZ
Blink Designs, Inc.
Ophthalmic · 19d
Cleared Aug 10, 1994
ELMED PNEUMOPERITONEUM NEEDLES
K943624 · FHO
Henke-Sass, Wolf GmbH
Gastroenterology & Urology · 15d
Cleared Aug 09, 1994
ANAESTHESIA RECORD KEEPER
K923172 · BSZ
Datex Division Instrumentarium Corp.
Anesthesiology · 771d
Cleared Aug 09, 1994
VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)
K926321 · IYE
Varian Assoc., Inc.
Radiology · 601d
Cleared Aug 09, 1994
BRANEMARK SYSTEM DRILL CONTROLLER
K931785 · DZE
Nobelpharma USA, Inc.
Dental · 487d
Cleared Aug 09, 1994
EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM
K932208 · DWF
Baxter Healthcare Corp
Cardiovascular · 460d
Cleared Aug 09, 1994
RFA A-300
K934303 · IYE
Scanditronix, Inc.
Radiology · 342d
Cleared Aug 09, 1994
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
K935055 · DOE
Roche Diagnostic Systems, Inc.
Toxicology · 293d