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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
76345–76368 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 2002
DERMASTAR ER:YAG LASER SYSTEM
K014057 · GEX
Asclepion-Meditec AG
General & Plastic Surgery · 88d
Cleared Mar 08, 2002
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
K014072 · KWY
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 88d
Cleared Mar 08, 2002
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
K014263 · JEY
Stryker Instruments
Dental · 71d
Cleared Mar 08, 2002
SALUTE, MODEL 3022
K014286 · GDW
Onux Medical, Inc.
General & Plastic Surgery · 71d
Cleared Mar 08, 2002
EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN...
K020094 · IOR
Regulatory Insight, Inc.
Physical Medicine · 56d
Cleared Mar 08, 2002
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL...
K020100 · IOR
Regulatory Insight, Inc.
Physical Medicine · 56d
Cleared Mar 08, 2002
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR
K020188 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 49d
Cleared Mar 08, 2002
SERRALENE, MODEL CATALOG NO 1S
K020265 · GAW
Serral, S.A. DE C.V.
General & Plastic Surgery · 42d
Cleared Mar 08, 2002
STERN MICRO ERA ATTACHMENT SYSTEM
K020391 · DZE
Sterngold
Dental · 30d
Cleared Mar 08, 2002
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
K020403 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared Mar 08, 2002
SAS VALUE HCG
K020438 · JHI
Sa Scientific, Inc.
Chemistry · 25d
Cleared Mar 08, 2002
MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE
K020470 · FZP
Bypass , Ltd.
General & Plastic Surgery · 24d
Cleared Mar 08, 2002
BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR
K020472 · IOR
Taiwan Armada Enterprise Co., Ltd.
Physical Medicine · 24d
Cleared Mar 08, 2002
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K020594 · ERL
Gyrus Ent LLC
Ear, Nose, Throat · 14d
Cleared Mar 08, 2002
SANARUS VISICA TREATMENT SYSTEM
K020605 · GEH
Sanarus Medical, Inc.
General & Plastic Surgery · 11d
Cleared Mar 07, 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 213d
Cleared Mar 07, 2002
OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND...
K012891 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 191d
Cleared Mar 07, 2002
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
K013168 · GGP
American Diagnostica, Inc.
Hematology · 167d
Cleared Mar 07, 2002
COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS
K014035 · GEX
Cooltouch Corp.
General & Plastic Surgery · 90d
Cleared Mar 07, 2002
TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE...
K014041 · HCG
Cordis Neurovascular
Neurology · 90d
Cleared Mar 07, 2002
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
K014075 · DQX
Baylis Medical Co., Inc.
Cardiovascular · 86d
Cleared Mar 07, 2002
NON-EUGENOL TEMPORARY CEMENT
K020158 · EMB
J. Morita USA, Inc.
Dental · 49d
Cleared Mar 07, 2002
MEDELA SYMPHONY BREAST PUMP, MODEL 024
K020518 · HGX
Medela, Inc.
Obstetrics & Gynecology · 16d
Cleared Mar 07, 2002
VIATRONIX V3D COLON
K020658 · LLZ
Viatronix, Inc.
Radiology · 6d