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
75841–75864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 06, 2002
PRIME ECG SYSTEM
K012414 · DPS
Meridian Medical Technologies, Inc.
Cardiovascular · 219d
Cleared Mar 06, 2002
TOWEL DRAPE, MODELS 4409, 4410
K012957 · KKX
Dynarex Corp.
General Hospital · 183d
Cleared Mar 06, 2002
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X
K013473 · MCW
Xtrak Medical, Inc.
Cardiovascular · 139d
Cleared Mar 06, 2002
REBILDA SC
K014111 · EBF
Voco GmbH
Dental · 82d
Cleared Mar 06, 2002
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
K020156 · MID
Axis-Shield Diagnostics, Ltd.
Immunology · 48d
Cleared Mar 06, 2002
ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES
K020359 · LYY
Ar Alliance Healthcare Sdn. Bhd.
General Hospital · 30d
Cleared Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
K020369 · JJX
Roche Diagnostics Corp.
Immunology · 30d
Cleared Mar 06, 2002
MICROSCAN SYNERGIES PLUS
K020511 · LON
Dade Microscan, Inc.
Microbiology · 19d
Cleared Mar 05, 2002
SPL-50 SPIROLYSER
K010761 · BZG
Fim Medical
Anesthesiology · 357d