Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
78169–78192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 06, 2001
BERNOULLI VENTILATOR MANAGEMENT SYSTEM
K011861 · MOD
Cardiopulmonary Corp.
Anesthesiology · 145d
Cleared Nov 06, 2001
PF 5050 PRESSURE UNIT, MODEL PF 5050
K011899 · DPW
Perimed AB
Cardiovascular · 141d
Cleared Nov 06, 2001
SURESET INFUSION SET, MODEL 8023
K012429 · FPA
Applied Diabetes Research, Incorporated
General Hospital · 98d
Cleared Nov 06, 2001
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...
K012617 · DWF
Jostra AG
Cardiovascular · 85d
Cleared Nov 06, 2001
SICKLE-CHEX
K013316 · GHM
Streck Laboratories, Inc.
Hematology · 33d
Cleared Nov 06, 2001
MODIFICATION TO SKYLIGHT IMAGING SYSTEM
K013496 · KPS
Adac Laboratories
Radiology · 15d
Cleared Nov 05, 2001
TST CONTROL INTEGRATOR FOR STEAM STERILIZERS
K002937 · LRT
Albert Browne , Ltd.
General Hospital · 410d