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
77041–77064 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 07, 2001
SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF
K013255 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 40d
Cleared Nov 07, 2001
MODIFICATION TO DEPUY C-STEM SYSTEM
K013350 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Nov 07, 2001
MODIFICATION TO: STACKABLE CAGE SYSTEM
K013382 · MQP
Depuyacromed
Orthopedic · 26d
Cleared Nov 07, 2001
GEMINI IMAGING SYSTEM
K013521 · JAK
Adac Laboratories
Radiology · 15d
Cleared Nov 07, 2001
SOMATOM P30 CT SYSTEMS
K013522 · JAK
Siemens Medical Systems, Inc.
Radiology · 15d
Cleared Nov 07, 2001
QWIKSIM VIRTUAL SIMULATION SYSTEM
K013531 · KPQ
Impac Medical Systems, Inc.
Radiology · 15d
Cleared Nov 06, 2001
WATCH-PAT 100
K010739 · MNR
Itamar Medical (C.M.) 1997 , Ltd.
Anesthesiology · 239d
Cleared Nov 06, 2001
PSYCHEMEDICS RIA COCAINE ASSAY
K010868 · KLN
Psychemedics Corp.
Toxicology · 228d
Cleared Nov 06, 2001
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK
K011195 · HNO
Surgin Surgical Instrumentation, Inc.
Ophthalmic · 201d