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

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176,076 results
60361–60384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2007
EXCEL CONTRA ANGLE HANDPIECE
K061897 · EGS
Orthosource, Inc.
Dental · 226d
Cleared Feb 14, 2007
ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT
K062069 · NHA
Atlantis Components, Inc.
Dental · 208d
Cleared Feb 14, 2007
IMMUNOCARD STAT! EHEC, MODEL 751630
K062546 · GMZ
Meridian Bioscience, Inc.
Microbiology · 168d
Cleared Feb 14, 2007
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K062569 · DXC
Datascope Corp.
Cardiovascular · 167d
Cleared Feb 14, 2007
MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
K063544 · KWQ
K2m, Inc.
Orthopedic · 82d
Cleared Feb 14, 2007
SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT
K063697 · KNW
PAJUNK GmbH Medizintechnologie
Gastroenterology & Urology · 63d
Cleared Feb 14, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML
K063824 · LON
Becton, Dickinson & CO
Microbiology · 50d
Cleared Feb 14, 2007
UNIBLATE ELECTROSURGICAL DEVICE
K070101 · GEI
Rita Medical Systems, Inc.
General & Plastic Surgery · 35d
Cleared Feb 13, 2007
BODIHEALTH SYSTEM
K052836 · GZJ
Usa Laser Therapeutics, Inc.
Neurology · 495d
Cleared Feb 13, 2007
COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS
K062200 · MQV
Collagen Matrix, Inc.
Orthopedic · 196d
Cleared Feb 13, 2007
CINCH BONE ANCHOR SYSTEM
K062739 · MBI
Sapphire Medical, Inc.
Orthopedic · 153d
Cleared Feb 13, 2007
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 125d
Cleared Feb 13, 2007
ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)
K063203 · ITI
Imc-Heart Way LLC
Physical Medicine · 113d
Cleared Feb 13, 2007
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K063860 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 47d
Cleared Feb 13, 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVE
K070187 · LYZ
Hong DI Plastic Products Co., Ltd.
General Hospital · 22d
Cleared Feb 12, 2007
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
K061252 · DYH
Primus Consulting
Dental · 284d
Cleared Feb 12, 2007
MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
K062953 · FIE
Medisystems Corp.
Gastroenterology & Urology · 136d
Cleared Feb 12, 2007
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28,...
K063441 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 12, 2007
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K063549 · LYC
Novabone Products, LLC
Dental · 80d
Cleared Feb 12, 2007
PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500
K070287 · EBA
Photonic Optische Gerate GmbH & Cokg
Dental · 14d
Cleared Feb 09, 2007
S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
K062012 · NKB
Aesculap, Inc.
Orthopedic · 207d
Cleared Feb 09, 2007
ELECTROPULSE - LOW BACK PAIN
K062532 · NUH
Pain Relief Technologies
Neurology · 165d
Cleared Feb 09, 2007
OK METER BLOOD GLUCOSE MONITORING SYSTEM
K063026 · NBW
Ok Biotech Co., Ltd.
Chemistry · 130d
Cleared Feb 09, 2007
DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
K063114 · FPK
Coeur, Inc.
General Hospital · 121d