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
78145–78168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2001
REPROCESSED DYONICS ARTHROSCOPIC BURS
K012652 · HRX
Alliance Medical Corp.
Orthopedic · 87d
Cleared Nov 08, 2001
REPROCESSED RF ARTHROSCOPY PROBES
K012679 · GEI
Sterilmed, Inc.
General & Plastic Surgery · 86d
Cleared Nov 08, 2001
REPROCESSED LASER PROBE
K012682 · GEX
Sterilmed, Inc.
General & Plastic Surgery · 86d
Cleared Nov 08, 2001
TULSA CONTRA ANGLES
K012720 · EFB
Dentsply Intl.
Dental · 85d
Cleared Nov 08, 2001
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · LYK
Smith & Nephew, Inc.
Cardiovascular · 86d
Cleared Nov 08, 2001
TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC...
K012725 · GEI
Endo-Therapeutics, Inc.
General & Plastic Surgery · 85d
Cleared Nov 08, 2001
MAROSIS PACS
K012844 · LLZ
Marotech, Inc.
Radiology · 77d
Cleared Nov 08, 2001
NEUROMOVE NM900
K012885 · IPF
Dan Med, Inc.
Physical Medicine · 72d
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