FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38329–38352 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2014
MATRICEL DENTAL BARRIER MEMBRANE
K123697 · NPL
Matricel GmbH
Dental · 448d
Cleared Feb 24, 2014
PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM
K131252 · CBK
Covidien
Anesthesiology · 298d
Cleared Feb 24, 2014
DALTON LIFT CHAIR
K131909 · INO
Dalton Instrument Corp.
Physical Medicine · 243d
Cleared Feb 24, 2014
AIR-FLOW HANDY 3.0 PERIO
K132480 · EFB
E.M.S Electro Medical Systems S.A
Dental · 200d
Cleared Feb 24, 2014
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS,...
K133404 · DGC
Phadia AB
Immunology · 110d
Cleared Feb 24, 2014
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
K133447 · NAJ
Celonova Biosciences, Inc.
Obstetrics & Gynecology · 104d
Cleared Feb 24, 2014
NEODENT IMPLANT SYSTEM
K133510 · DZE
Jj Industria E Comercio DE Materiais...
Dental · 102d
Cleared Feb 24, 2014
WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
K133615 · EZD
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 91d
Cleared Feb 24, 2014
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT...
K133625 · MOF
Codman & Shurtleff, Inc.
Neurology · 90d
Cleared Feb 24, 2014
EXTRIMILOCK ANKLE PLATING SYSTEM
K133691 · HRS
Osteomed LP
Orthopedic · 84d
Cleared Feb 21, 2014
AXIOM REG
K131066 · DZE
Anthogyr Sas
Dental · 311d
Cleared Feb 21, 2014
MEDLINE BIOPSY VALVE
K131426 · OCX
Medline Industries, Inc.
Gastroenterology & Urology · 280d
Cleared Feb 21, 2014
FREEDOM PCK COMPONENTS
K131481 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 275d
Cleared Feb 21, 2014
POLAROID CONTACTSPOD
K131783 · LRX
Viopti, Ltd.
Ophthalmic · 249d
Cleared Feb 21, 2014
OXYGEN GENERATOR LIQUEFIER - (OGL)
K131990 · CAW
Essex Cryogenics of Missouri, Inc.
Anesthesiology · 238d
Cleared Feb 21, 2014
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
K132039 · EQN
Jedmed Instrument Co.
Ear, Nose, Throat · 234d
Cleared Feb 21, 2014
NOVOHIP TOTAL HIP SYSTEM
K132158 · LPH
Novosource, Inc.
Orthopedic · 224d
Cleared Feb 21, 2014
STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT...
K132219 · NHA
Straumann USA, LLC
Dental · 219d
Cleared Feb 21, 2014
OMNI PATENT MONITORS
K132229 · MWI
Infinium Medical
Cardiovascular · 218d
Cleared Feb 21, 2014
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
K132402 · DQA
Nonin Medical, Inc.
Anesthesiology · 204d
Cleared Feb 21, 2014
FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER
K132457 · FLL
Biocare Asia Corporation , Ltd.
General Hospital · 199d
Cleared Feb 21, 2014
FLAATZ 600 SERIES (FLAATZ 600/601)
K132842 · MQB
Drtech Corp.
Radiology · 164d
Cleared Feb 21, 2014
LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE...
K132874 · JAQ
Nucletron B.V.
Radiology · 161d
Cleared Feb 21, 2014
ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1...
K132935 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 156d