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
85753–85776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 1999
MODIFICATION OF:BIODERM FOAM WOUND DRESSING
K990955 · KMF
Bioderm, Inc.
General & Plastic Surgery · 57d
Cleared May 18, 1999
SIGNADRESS DUODERM DRESSING
K990964 · KGN
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 56d
Cleared May 18, 1999
TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001...
K991324 · KHJ
Heinz Kurz
Ear, Nose, Throat · 29d
Cleared May 18, 1999
STAPES PROSTHESES
K991394 · ETB
Grace Medical, Inc.
Ear, Nose, Throat · 27d
Cleared May 18, 1999
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 11d
Cleared May 17, 1999
CVS PERSONAL LUBRICANT
K983216 · HIS
San-Mar Laboratories, Inc.
Obstetrics & Gynecology · 245d
Cleared May 17, 1999
MANOMETRIC ASSEMBLIES
K983665 · KLA
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 210d
Cleared May 17, 1999
ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS...
K983720 · MSE
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 208d
Cleared May 17, 1999
SYNERGY IOM SYSTEM
K984052 · IKN
Oxford Instruments Medical Systems
Neurology · 185d
Cleared May 17, 1999
LATEX EXAMINATION GLOVES (POWDERED)
K984229 · LYY
Sama Kejuruteraan Sdn.Bhd.
General Hospital · 173d
Cleared May 17, 1999
TOTALBOND
K990381 · EMA
Parkell, Inc.
Dental · 98d
Cleared May 17, 1999
ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND...
K990474 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 90d
Cleared May 17, 1999
INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
K990585 · ETY
Idem (Int'L Dist. of Electronics For...
Ear, Nose, Throat · 83d
Cleared May 17, 1999
CONMED ABC PROBE FOR FLEXIBLE ENDOSCOPES
K990586 · GEI
Conmedcorp
General & Plastic Surgery · 83d
Cleared May 17, 1999
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
K990652 · ETY
Idem (Int'L Dist. of Electronics For...
Ear, Nose, Throat · 77d
Cleared May 17, 1999
BQ/BM INTEGRATED LASER DELIVERY SYSTEM
K990665 · HQF
American Laser Corp.
Ophthalmic · 76d
Cleared May 17, 1999
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9)
K990669 · LTZ
Dongkuk Techco Rubber Industries Sdn....
Obstetrics & Gynecology · 76d
Cleared May 17, 1999
ORTHO-GLOW GLITTER
K990699 · EBI
Harry J. Bosworth Co.
Dental · 75d
Cleared May 17, 1999
GALLINI BYCUT NEEDLE
K990716 · KNW
Gallini U.S., LLC
Gastroenterology & Urology · 74d
Cleared May 17, 1999
NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE
K990840 · LZA
Terang Nusa Sdn Bhd
General Hospital · 63d
Cleared May 17, 1999
NUGARD NITRIL NITRILE EXAMINATION GLOVE
K990841 · LZA
Terang Nusa Sdn Bhd
General Hospital · 63d
Cleared May 17, 1999
TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION...
K990848 · LXT
Immedica, Inc.
Orthopedic · 63d
Cleared May 17, 1999
PRE POWDERED LATEX EXAMINATION GLOVES
K990879 · LYY
Apl Products Sdn. Bhd.
General Hospital · 62d
Cleared May 17, 1999
JACKSON ESOPHAGEAL DILATOR
K990935 · KNQ
Pilling Weck Surgical
Gastroenterology & Urology · 59d