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
79585–79608 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 15, 2001
CRYOCARE CARDIAC SURGICAL SYSTEM
K011040 · OCL
Endocare, Inc.
Cardiovascular · 71d
Cleared Jun 15, 2001
OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE
K011183 · GCJ
Advanced Surgical Concepts (Asc)
General & Plastic Surgery · 58d
Cleared Jun 15, 2001
MODIFICATION TO THE BOLD SCREW
K011262 · HWC
New Deal, S.A.
Orthopedic · 51d
Cleared Jun 15, 2001
EXCEL FRACTURE CEMENTED HIP STEM
K011367 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 42d
Cleared Jun 15, 2001
OMNILINK .035 BILIARY STENT SYSTEM
K011506 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Jun 15, 2001
EEG MIS MONITOR MODEL # A-2000
K011534 · OLW
Aspect Medical Systems, Inc.
Neurology · 28d
Cleared Jun 15, 2001
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
K011572 · KPS
Digirad Corp.
Radiology · 25d
Cleared Jun 15, 2001
OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL...
K011622 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jun 15, 2001
EXETER HIP SYSTEM WITH V40 TAPER
K011623 · JDI
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jun 14, 2001
COMOACT ULTRASONIC NEBULIZER, MODEL 3060
K002543 · CAF
San UP S.A.
Anesthesiology · 302d
Cleared Jun 14, 2001
PULSECO HEMODYNAMIC MONITOR CM71
K010049 · DXG
Lidco, Ltd.
Cardiovascular · 160d
Cleared Jun 14, 2001
COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH
K010055 · DRE
Cook Vascular, Inc.
Cardiovascular · 157d
Cleared Jun 14, 2001
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
K010093 · CBK
Drager Medizintechnik GmbH
Anesthesiology · 154d
Cleared Jun 14, 2001
PORTABLE INSTENSIVE CARE UNIT
K010207 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 142d
Cleared Jun 14, 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
K011035 · JIX
Dade Behring, Inc.
Chemistry · 70d
Cleared Jun 14, 2001
BCI 3403 SLEEP SCREENING PULSE OXIMETER
K011156 · DQA
Bci, Inc.
Anesthesiology · 59d
Cleared Jun 14, 2001
GILB, MODEL 8010
K011200 · EMA
3M Company
Dental · 56d
Cleared Jun 14, 2001
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
K011409 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 37d
Cleared Jun 14, 2001
BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
K011446 · KGO
Barriermed, Inc.
General Hospital · 34d
Cleared Jun 14, 2001
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138
K011523 · DXN
Rossmax International , Ltd.
Cardiovascular · 28d
Cleared Jun 14, 2001
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129,...
K011526 · MJN
Micro Therapeutics, Inc.
Cardiovascular · 28d
Cleared Jun 13, 2001
MEMODYN STAPLE
K002695 · JDR
Telos Medical Equipment
Orthopedic · 288d
Cleared Jun 13, 2001
YOUNG-HEALTH SUPER EAR THERMOMETER
K002727 · FLL
Young Health Ind. Co., Ltd.
General Hospital · 286d
Cleared Jun 13, 2001
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL...
K003259 · LGD
Beckman Coulter, Inc.
Microbiology · 238d