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
77281–77304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 2002
CENTRIFUGAL PUMP
K011838 · DWA
Stockert Instrumente GmbH
Cardiovascular · 238d
Cleared Feb 05, 2002
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
K012274 · LDD
Medtronic Physio-Control Corp.
Cardiovascular · 201d
Cleared Feb 05, 2002
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE...
K012463 · GXY
Everyway Medical Instruments Co.,Ltd
Neurology · 188d
Cleared Feb 05, 2002
VASCUPUNCTURE ACCESS WIRE
K012861 · DQX
Neometrics, Inc.
Cardiovascular · 165d
Cleared Feb 05, 2002
TRAPSYSTEM SET
K013692 · KNW
H.S. Hospital Service S.R.L.
Gastroenterology & Urology · 90d
Cleared Feb 05, 2002
ORTHOSIS HELMET MOLDING
K013700 · MVA
Precision Prosthetics & Orthotics, Inc.
Neurology · 89d
Cleared Feb 05, 2002
BECKER BAND CRANIAL REMOLDING ORTHOSIS
K013719 · MVA
Becker Orthopedic Appliance Co.
Neurology · 89d
Cleared Feb 05, 2002
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
K013891 · DZE
Institut Straumann AG
Dental · 74d
Cleared Feb 05, 2002
CANVAS N-VAS-D 2.0
K014011 · LNH
Vassol, Inc.
Radiology · 62d
Cleared Feb 05, 2002
CTL BODY / SPINE ARRAY COIL
K014086 · MOS
Usa Instruments, Inc.
Radiology · 56d
Cleared Feb 05, 2002
ERECAID CLASSIC SYSTEM
K020082 · LKY
Endocare, Inc.
Gastroenterology & Urology · 26d
Cleared Feb 05, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K020141 · KTT
Ebi, L.P.
Orthopedic · 20d
Cleared Feb 05, 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155 · KWP
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Feb 04, 2002
MEDIGROUP CATHETER EXTENDER/REPAIR KIT
K012502 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 185d
Cleared Feb 04, 2002
ADVANCED AIR PURIFICATION SYSTEM
K012549 · FRF
Healthway Products, Inc.
General Hospital · 181d
Cleared Feb 04, 2002
REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
K012676 · HWE
Adven Medical
Orthopedic · 174d
Cleared Feb 04, 2002
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
K012694 · HWE
Adven Medical
Orthopedic · 174d
Cleared Feb 04, 2002
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT...
K013254 · LZA
Top Quality Mfg., Inc.
General Hospital · 129d
Cleared Feb 04, 2002
EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
K013640 · FDS
Pentax Precision Instrument Corp.
Radiology · 91d
Cleared Feb 04, 2002
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 04, 2002
BERCHTOLD ELEKTROTOM 106 HITT
K013668 · GEI
Berchtold Corp.
General & Plastic Surgery · 90d
Cleared Feb 04, 2002
ENDO-GLIDE
K013701 · GCJ
Sonotech, Inc.
General & Plastic Surgery · 88d
Cleared Feb 04, 2002
TEMPFIL
K013895 · EBG
Sybron Dental Specialties, Inc.
Dental · 73d
Cleared Feb 04, 2002
VERAVIEWEPOCS, MODEL VE
K013955 · EHD
J. Morita USA, Inc.
Radiology · 66d