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
77185–77208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2002
BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230
K013904 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 78d
Cleared Feb 12, 2002
WATERLASE MILLENNIUM
K013908 · MXF
Biolase Technology, Inc.
Dental · 78d
Cleared Feb 12, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
K014261 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 47d
Cleared Feb 12, 2002
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
K020083 · HRX
Tuta Healthcare Pty Limited
Orthopedic · 33d
Cleared Feb 12, 2002
E-SCAN XQ
K020164 · LNH
Biosound Esaote, Inc.
Radiology · 26d
Cleared Feb 12, 2002
HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
K020232 · CGA
Hypoguard USA, Inc.
Chemistry · 29d
Cleared Feb 12, 2002
NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA
K020295 · JWH
Implex Corp.
Orthopedic · 15d
Cleared Feb 12, 2002
MODIFICATION TO VISTA STEREOSCOPE SYSTEM
K020301 · FET
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 14d
Cleared Feb 12, 2002
P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM
K020362 · CAW
On Site Gas Systems, Inc.
Anesthesiology · 8d
Cleared Feb 11, 2002
INCLUDER CLAMP
K010694 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 340d
Cleared Feb 11, 2002
STONELITH, MODEL V5
K011106 · LNS
Pck Electronic Industry and Trade Co,...
Gastroenterology & Urology · 306d
Cleared Feb 11, 2002
PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY
K011275 · LCL
Psychemedics Corp.
Toxicology · 291d
Cleared Feb 11, 2002
MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
K012052 · JXG
Medtronic PS Medical
Neurology · 224d
Cleared Feb 11, 2002
PORTEX RING PESSARY PVC-NON STERILE
K012277 · HHW
Sims Portex , Ltd.
Obstetrics & Gynecology · 207d
Cleared Feb 11, 2002
SOLAR 8000M SYSTEM
K012467 · DSI
General Electric Medical Systems...
Cardiovascular · 194d
Cleared Feb 11, 2002
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · JOW
Sterilmed, Inc.
Cardiovascular · 185d
Cleared Feb 11, 2002
BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS...
K012811 · MQH
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 173d
Cleared Feb 11, 2002
PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
K013223 · CAW
Litton Systems, Inc.
Anesthesiology · 137d
Cleared Feb 11, 2002
LUMEND FRONTRUNNER CTO CORONARY CATHETER
K013284 · DQY
Lumend, Inc.
Cardiovascular · 132d
Cleared Feb 11, 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K013479 · LPN
Allergan, Inc.
Ophthalmic · 115d
Cleared Feb 11, 2002
TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH)
K013635 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 98d
Cleared Feb 11, 2002
MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
K013722 · IYN
Hitachi Medical Corp.
Radiology · 94d
Cleared Feb 11, 2002
TEKNO-MEDICAL OBSTETRICAL FORCEPS
K013747 · HDA
Tekno Medical Optik-Chirurgie GmbH & Co.
Obstetrics & Gynecology · 90d
Cleared Feb 11, 2002
CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)
K013748 · GEX
Candela Corp.
General & Plastic Surgery · 90d