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
71761–71784 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2003
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K031692 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 81d
Cleared Aug 22, 2003
MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332
K032005 · FRN
Medtronic Minimed
General Hospital · 53d
Cleared Aug 22, 2003
ROCHE ONLINE TDM VALPROIC ACID
K032049 · LEG
Roche Diagnostics Corp.
Toxicology · 51d
Cleared Aug 22, 2003
CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200
K032068 · DTR
Cardiovention, Inc.
Cardiovascular · 50d
Cleared Aug 22, 2003
Trellis Reserve Infusion System
K032261 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 30d
Cleared Aug 22, 2003
VERSATREK
K032306 · MDB
Trek Diagnostic Systems, Inc.
Microbiology · 28d
Cleared Aug 22, 2003
VITEK 2 GRAM POSITIVE GATIFLOXACIN
K032314 · LON
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 22, 2003
ALTATEC CERAMIC ABUTMENT
K032448 · NHA
Altatec Biotechnologies
Dental · 14d
Cleared Aug 22, 2003
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA...
K032464 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 11d
Cleared Aug 22, 2003
SPIDERVIEW
K032466 · MWJ
Ela Medical, Inc.
Cardiovascular · 11d
Cleared Aug 22, 2003
VIATRONIX V3D EXPLORER, REVISION 1.2
K032483 · LLZ
Viatronix, Inc.
Radiology · 10d
Cleared Aug 22, 2003
EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K032503 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 9d
Cleared Aug 21, 2003
COLUMBUS (PS)
K030367 · JWH
Aesculap, Inc.
Orthopedic · 198d
Cleared Aug 21, 2003
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
K030574 · KMF
Glustitch, Inc.
General & Plastic Surgery · 178d
Cleared Aug 21, 2003
DENTAPORT ZX
K031204 · EKX
J. Morita USA, Inc.
Dental · 127d
Cleared Aug 21, 2003
SYNTHES (USA) CALVICLE HOOK PLATE
K031677 · HRS
Synthes (Usa)
Orthopedic · 83d
Cleared Aug 21, 2003
CENTURION SES EPIKERATOME
K031735 · HNO
Ciba Vision Corporation
Ophthalmic · 78d
Cleared Aug 21, 2003
BODYGUARD INFUSION SYSTEM
K031749 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 77d
Cleared Aug 21, 2003
SHIMADZU COLLIMATOR R-30H
K031771 · IZX
Shimadzu Corp.
Radiology · 73d
Cleared Aug 21, 2003
NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
K031885 · HBL
Image-Guided Neurologics, Inc.
Neurology · 64d
Cleared Aug 21, 2003
NPAC DIGITAL THERMOMETER, MODELS ET 300, 301, 350, 351
K031907 · FLL
Norm Pacific Automation Corp.
General Hospital · 62d
Cleared Aug 21, 2003
COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS
K031954 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 57d
Cleared Aug 21, 2003
LINVATEC 300W XENON LIGHT SOURCE
K031994 · GCT
Linvatec Corp.
Gastroenterology & Urology · 55d
Cleared Aug 21, 2003
TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
K032057 · DIO
Branan Medical Corp.
Toxicology · 50d