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
58657–58680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2007
STATIS DENTAL HANDPIECES
K071891 · EFB
Scican , Ltd.
Dental · 66d
Cleared Sep 13, 2007
DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL
K072150 · EBF
Novocol, Inc.
Dental · 41d
Cleared Sep 13, 2007
BRK TRANSSEPTAL NEEDLE
K072278 · DRC
St Jude Medical
Cardiovascular · 28d
Cleared Sep 13, 2007
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
K072387 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 20d
Cleared Sep 13, 2007
USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
K072405 · FED
Usgi Medical
Gastroenterology & Urology · 17d
Cleared Sep 13, 2007
CURE CATHETER
K072539 · EZD
Cure Medical, LLC
Gastroenterology & Urology · 3d
Cleared Sep 12, 2007
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
K063609 · DXH
Shl Telemedicine International , Ltd.
Cardiovascular · 282d
Cleared Sep 12, 2007
INTRAVASCULAR INTRODUCER SYSTEM
K063658 · DYB
Applied Medical Resources Corp.
Cardiovascular · 278d
Cleared Sep 12, 2007
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662
K070653 · FRO
Tyco Healthcare
General & Plastic Surgery · 187d
Cleared Sep 12, 2007
REPROCESSED ETHICON ETS ENDOSCOPIC LINEAR CUTTERS
K070859 · NLL
Sterilmed, Inc.
General & Plastic Surgery · 168d
Cleared Sep 12, 2007
TROJAN THINTENSITY BRAND MALE LATEX CONDOM
K071272 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 128d
Cleared Sep 12, 2007
POCKETCPR
K071321 · LIX
Bio-Detek, Inc.
Cardiovascular · 125d
Cleared Sep 12, 2007
MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C,...
K071437 · HWC
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 112d
Cleared Sep 12, 2007
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
K071644 · DLZ
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Sep 12, 2007
C350 POWERED WHEELCHAIR
K071650 · ITI
Permobil AB
Physical Medicine · 86d
Cleared Sep 12, 2007
SENTEC DIGITAL MONITORING SYSTEM
K071672 · DQA
Sentec AG
Anesthesiology · 85d
Cleared Sep 12, 2007
CPAP NASAL MASK WITH PILLOWS
K071773 · BZD
Lifesource
Anesthesiology · 75d
Cleared Sep 12, 2007
NEOPIP INFANT RESUSCITATOR
K072021 · BTM
Neoforce Group, Inc.
Anesthesiology · 51d
Cleared Sep 12, 2007
ELLIPSE JUVIA, MODEL 9EJU7465
K072023 · GEX
Ellipse A/S
General & Plastic Surgery · 51d
Cleared Sep 12, 2007
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
K072038 · LON
bioMerieux, Inc.
Microbiology · 49d
Cleared Sep 12, 2007
BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM
K072297 · DXC
Cardiva Medical, Inc.
Cardiovascular · 26d
Cleared Sep 12, 2007
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN...
K072308 · DTM
Sorin Group Italia S.R.L.
Cardiovascular · 26d
Cleared Sep 12, 2007
PORTRAIT STAND-OFF
K072394 · GEI
Rhytec Incorporated
General & Plastic Surgery · 16d
Cleared Sep 12, 2007
OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
K072418 · CAF
Respironics New Jersey, Inc.
Anesthesiology · 15d