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
58801–58824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2007
ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT
K072196 · LJS
AngioDynamics, Inc.
General Hospital · 20d
Cleared Aug 24, 2007
LORENZ BIOTECH APTIVA, VERSION 2.13
K061828 · GZJ
Lorenz Biotech S.P.A.
Neurology · 422d
Cleared Aug 24, 2007
LATITUDE ELBOW PROTHESIS
K070787 · JDB
Tornier
Orthopedic · 155d
Cleared Aug 24, 2007
TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS
K071010 · EIH
Schutz-Dental GmbH
Dental · 137d
Cleared Aug 24, 2007
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
K071029 · DQX
Stereotaxis, Inc.
Cardiovascular · 135d
Cleared Aug 24, 2007
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
K071263 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 109d
Cleared Aug 24, 2007
GSO GS1 SPACER
K071274 · MQP
Gold Standard Orthopedics, LLC
Orthopedic · 109d
Cleared Aug 24, 2007
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
K071336 · QEZ
Possis Medical, Inc.
Cardiovascular · 105d
Cleared Aug 24, 2007
PMAX NEWTRON XS
K071424 · ELC
Satelec - Acteon Group
Dental · 93d
Cleared Aug 24, 2007
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP
K071476 · JEC
Synthes (Usa)
Orthopedic · 87d
Cleared Aug 24, 2007
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
K071530 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 80d
Cleared Aug 24, 2007
ETOH FLEX REAGENT CARTRIDGE (DF22)
K071811 · DIC
Dade Behring, Inc.
Toxicology · 52d
Cleared Aug 24, 2007
AMS MINIARC SLING SYSTEM
K071902 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 45d
Cleared Aug 24, 2007
IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01
K071913 · DHB
Phadia AB
Immunology · 44d
Cleared Aug 24, 2007
CHISON, MODEL 8300
K072210 · IYO
Chison Medical Imaging Co., Ltd.
Radiology · 15d
Cleared Aug 23, 2007
SMALL VOLUME SYRINGE
K062865 · FMF
Alcon Laboratories
General Hospital · 332d
Cleared Aug 23, 2007
SPINEASSIST SYSTEM
K063607 · HAW
Mazor Surgical Technologies , Ltd.
Neurology · 262d
Cleared Aug 23, 2007
R-PORT LAPAROSCOPIC ACCESS DEVICE
K070158 · GCJ
Advanced Surgical Concepts
General & Plastic Surgery · 218d
Cleared Aug 23, 2007
SC PROFI FINE PEN NEEDLE, MODELS
K070988 · FMI
Shinchang Medical Co., Ltd.
General Hospital · 139d
Cleared Aug 23, 2007
DOCTOR'S LIGHT LED DENTAL CURING LIGHT
K071908 · EBZ
Good Doctors Co., Ltd.
Dental · 44d
Cleared Aug 23, 2007
WOUNDSTAT, MODEL TC1001
K071936 · QSY
Traumacure, Inc.
General & Plastic Surgery · 41d
Cleared Aug 23, 2007
THROMCAT THROMBECTOMY CATHETER SYSTEM
K072195 · MCW
Kensey Nash Corp.
Cardiovascular · 16d
Cleared Aug 23, 2007
DURAGEN XS DURAL REGENERATION MATRIX
K072207 · GXQ
Integra Lifesciences Corp.
Neurology · 15d
Cleared Aug 23, 2007
PEDI CO2 EASY
K072220 · CCK
Westmed, Inc.
Anesthesiology · 13d