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
59425–59448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2007
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
K070880 · EWO
Etymotic Research, Inc.
Ear, Nose, Throat · 69d
Cleared Jun 07, 2007
ELECTRODE/EXTENSION CABLES, MODELS ATAR
K070926 · IKD
Oscor, Inc.
Physical Medicine · 65d
Cleared Jun 07, 2007
SACS EEG WORKSTATION A7
K071109 · GWQ
Sacs Medical AB
Neurology · 50d
Cleared Jun 07, 2007
MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002
K071140 · KCY
Top Spins, Inc.
Radiology · 44d
Cleared Jun 06, 2007
SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM
K070756 · MBL
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Jun 06, 2007
SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES
K070946 · HRS
Synthes (Usa)
Orthopedic · 63d
Cleared Jun 06, 2007
BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
K071141 · GKZ
Bd Biosciences
Hematology · 43d
Cleared Jun 06, 2007
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
K071142 · BSZ
Datex-Ohmeda
Anesthesiology · 43d
Cleared Jun 06, 2007
BD TRITEST CD3/CD4/CD45, MODEL 340383
K071143 · GKZ
Bd Biosciences
Hematology · 43d
Cleared Jun 05, 2007
ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN...
K060434 · CIX
Horiba Abx
Chemistry · 469d
Cleared Jun 05, 2007
ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981,...
K070417 · DYB
St Jude Medical
Cardiovascular · 113d
Cleared Jun 05, 2007
GENIE, MODEL CH-200
K070633 · FMF
Icu Medical, Inc.
General Hospital · 90d
Cleared Jun 05, 2007
DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300
K070878 · FLL
Rg Medical Diagnostics
General Hospital · 68d
Cleared Jun 05, 2007
AURALAY PIT & FISSURE SEALANT
K071158 · EBC
Denali Corporation
Dental · 41d
Cleared Jun 05, 2007
ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
K071249 · FTL
Ethicon, Inc.
General & Plastic Surgery · 32d
Cleared Jun 05, 2007
AMARIS/AMARIS FLOW
K071386 · EBF
Voco GmbH
Dental · 18d
Cleared Jun 05, 2007
UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
K071462 · ETW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 11d
Cleared Jun 04, 2007
SUNMED FOLEY CATHETERS
K062112 · EZL
Sunmed, Inc.
Gastroenterology & Urology · 315d
Cleared Jun 04, 2007
INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL
K070566 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 96d
Cleared Jun 04, 2007
OLYMPUS CK-MB REAGENT
K070835 · JHY
Olympus Life & Material Science...
Chemistry · 69d
Cleared Jun 04, 2007
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH...
K070951 · PNO
Boston Scientific
Cardiovascular · 61d
Cleared Jun 01, 2007
ARTELON CMC SPACER ARTHRO
K061954 · KYI
Artimplant AB
Orthopedic · 325d
Cleared Jun 01, 2007
OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP,...
K062636 · DZE
Implant Innovations, Inc.
Dental · 269d
Cleared Jun 01, 2007
IMDX SYSTEMS
K063699 · DJG
Novx Systems, Inc.
Chemistry · 170d