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
77545–77568 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO,...
K013073 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 55d
Cleared Nov 08, 2001
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
K013339 · DTB
Oscor, Inc.
Cardiovascular · 30d
Cleared Nov 08, 2001
EBI XFIX DFS SYSTEM
K013378 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Nov 08, 2001
LIFTLOC SAFETY INFUSION SET
K013394 · FPA
Specialized Health Products, Inc.
General Hospital · 24d
Cleared Nov 08, 2001
LIGHTSPEED 4.0 CT SCANNER SYSTEM
K013561 · JAK
GE Medical Systems
Radiology · 13d
Cleared Nov 07, 2001
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120,...
K010989 · MQP
Interpore Cross Intl.
Orthopedic · 218d
Cleared Nov 07, 2001
DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR
K011070 · GEX
Moor Instruments, Ltd.
General & Plastic Surgery · 212d
Cleared Nov 07, 2001
PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES
K011174 · GEX
Fotona D.D.
General & Plastic Surgery · 204d
Cleared Nov 07, 2001
BODY FAT ANALYZER, MODEL HBF-306
K011652 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 162d
Cleared Nov 07, 2001
REPROCESSED HARMONIC
K012571 · NLQ
Sterilmed, Inc.
General & Plastic Surgery · 90d
Cleared Nov 07, 2001
REPROCESSED ENDOSCOPIC TROCAR
K012578 · NLM
Sterilmed, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 07, 2001
REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS
K012598 · NUJ
Sterilmed, Inc.
General & Plastic Surgery · 89d
Cleared Nov 07, 2001
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
K012603 · NUJ
Alliance Medical Corp.
General & Plastic Surgery · 86d
Cleared Nov 07, 2001
REPROCESSED ATHROSCOPICS BURS
K012605 · HRX
Alliance Medical Corp.
Orthopedic · 86d
Cleared Nov 07, 2001
REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
K012611 · HRX
Alliance Medical, Inc.
Orthopedic · 86d
Cleared Nov 07, 2001
REPROCSSED LINVATEC SHAVERS
K012613 · HRX
Alliance Medical, Inc.
Orthopedic · 86d
Cleared Nov 07, 2001
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS
K012635 · HRX
Alliance Medical Corp.
Orthopedic · 86d
Cleared Nov 07, 2001
CONGRUENT BONE PLATE SYSTEM
K012655 · HRS
Acu Med, Inc.
Orthopedic · 86d
Cleared Nov 07, 2001
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS
K012700 · GEI
Vanguard Medical Concepts, Inc.
General & Plastic Surgery · 85d
Cleared Nov 07, 2001
DUR-8, MODELS DUR-8
K012925 · FGB
Circon Video
Gastroenterology & Urology · 68d
Cleared Nov 07, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
K012987 · JIX
Phoenix Diagnostics, Inc.
Chemistry · 62d
Cleared Nov 07, 2001
MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP
K013124 · DJJ
Branan Medical Corp.
Toxicology · 49d
Cleared Nov 07, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
K013195 · LTT
Trek Diagnostic Systems, Inc.
Microbiology · 43d
Cleared Nov 07, 2001
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
K013222 · MNI
Depuyacromed
Orthopedic · 41d