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
58753–58776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2007
IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP
K071299 · NFJ
Digital Healthcare, Ltd.
Ophthalmic · 114d
Cleared Aug 31, 2007
VISUALASE THERMAL THERAPY SYSTEM
K071328 · GEX
Biotex, Inc.
Radiology · 112d
Cleared Aug 31, 2007
IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX
K071470 · FTL
Implantech Associates, Inc.
General & Plastic Surgery · 94d
Cleared Aug 31, 2007
MOTIVA MONITOR DEVICE CONNECTIVITY, MODEL# 453564036921
K071564 · DRG
Philips Medical Systems
Cardiovascular · 85d
Cleared Aug 31, 2007
OASIS RELEASE 1.0
K071584 · LLZ
Segami Corporation
Radiology · 81d
Cleared Aug 31, 2007
BIOSIGN CENTRAL STATION
K071606 · MWI
Obs Medical
Cardiovascular · 80d
Cleared Aug 31, 2007
VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900
K071660 · OBJ
Volcano Corporation
Cardiovascular · 74d
Cleared Aug 31, 2007
DENTAL MATRIX BAND
K071858 · DZN
Fly Cast Technologies, Inc.
Dental · 57d
Cleared Aug 31, 2007
ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS)
K071863 · HTY
Bioretec, Ltd.
Orthopedic · 56d
Cleared Aug 31, 2007
DAR-9400F
K072006 · IZI
Shimadzu Corp.
Radiology · 39d
Cleared Aug 31, 2007
MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
K072108 · FLL
Tecnimed S.R.L.
General Hospital · 30d
Cleared Aug 31, 2007
DOMINATOR
K072127 · HWC
Biocomposites, Ltd.
Orthopedic · 29d
Cleared Aug 31, 2007
JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE
K072172 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 25d
Cleared Aug 30, 2007
VERTEFIX PEDICLE SCREW SPINAL SYSTEM
K063453 · MNI
Elite Surgical Supplies (Pty), Ltd.
Orthopedic · 288d
Cleared Aug 30, 2007
EASYRA CLINICAL CHEMISTRY ANALYZER
K070057 · CGA
Medica Corp.
Chemistry · 237d
Cleared Aug 30, 2007
DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000
K070206 · GQW
Diagnostic Hybrids, Inc.
Microbiology · 220d
Cleared Aug 30, 2007
STORZ SLX-F2 STORM TOUCH
K070579 · LNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 182d
Cleared Aug 30, 2007
SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
K071072 · LZA
Shanghai China Star Corp
General Hospital · 136d
Cleared Aug 30, 2007
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT...
K071427 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 99d
Cleared Aug 30, 2007
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS...
K071538 · FOZ
Arrow International, Inc.
General Hospital · 86d
Cleared Aug 30, 2007
QUICKBRIDGE TM CYLINDER AND CAP
K071551 · NHA
Biomet 3i, Inc.
Dental · 85d
Cleared Aug 30, 2007
FORTAGEN ORAL MEMBRANE
K071555 · NPL
Organogenesis, Inc.
Dental · 84d
Cleared Aug 30, 2007
MODIFICATION TO EZ HUBER SAFETY INFUSION SET
K071846 · FPA
Pfm Medical, Inc.
General Hospital · 56d
Cleared Aug 30, 2007
IPS INLINE POM SYSTEM
K071848 · EIH
Ivoclar Vivadent, Inc.
Dental · 56d