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
56305–56328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 2008
SYMPHONY GLUCOSE MANAGEMENT SYSTEM
K080639 · LZG
Animas Corp.
General Hospital · 110d
Cleared Jun 24, 2008
VISUAL FOOTCARE TECHNOLOGIES TEMPSTAT
K080816 · OIZ
Visual Footcare Technologies, LLC
General Hospital · 92d
Cleared Jun 24, 2008
ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION,...
K080879 · HTY
Bioretec, Ltd.
Orthopedic · 85d
Cleared Jun 24, 2008
IPLAN RT IMAGE
K080886 · LHN
Brainlab AG
Radiology · 85d
Cleared Jun 24, 2008
AVITA RADAR THERMO IR THERMOMETER, NT1 SERIES
K081160 · FLL
Avita Corporation
General Hospital · 62d
Cleared Jun 24, 2008
ECARD AND CCARD
K081471 · DXH
iRhythm Technologies, Inc.
Cardiovascular · 28d
Cleared Jun 24, 2008
DIGITAL RADIOGRAPHY CXDI-60G
K081648 · MQB
Canon, Inc.
Radiology · 12d
Cleared Jun 24, 2008
HD15 DIAGNOSTIC ULTRASOUND SYSTEM
K081661 · IYN
Philips Ultrasound, Inc.
Radiology · 11d
Cleared Jun 23, 2008
NUCLISENS EASYQ ENTEROVIRUS SYSTEM
K063261 · OAI
bioMerieux, Inc.
Microbiology · 602d
Cleared Jun 23, 2008
BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5
K073280 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 215d
Cleared Jun 23, 2008
SHARPS TRANSPORT TUBE, MODEL 50035
K073577 · MMK
Sharps Compliance, Inc.
General Hospital · 186d
Cleared Jun 23, 2008
LAMIN AIR
K080516 · BZD
Remgenic, LLC
Anesthesiology · 119d
Cleared Jun 23, 2008
CLEVER CHEK AUTO-CODE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4243
K081144 · NBW
Taidoc Technology Corporation
Chemistry · 62d
Cleared Jun 23, 2008
BIOGRAPH HD FAMILY
K081453 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 31d
Cleared Jun 23, 2008
INFX-8000C (INFINIX CC-I AND VC-I)
K081621 · JAA
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 23, 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
K081624 · MQB
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Jun 23, 2008
NOMAD PRO X-RAY SYSTEM
K081664 · EHD
Aribex, Inc.
Radiology · 10d
Cleared Jun 20, 2008
EPLEY OMNIAX
K071973 · LXV
Vesticon
Ear, Nose, Throat · 339d
Cleared Jun 20, 2008
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
K072985 · KYB
Duckworth & Kent, Ltd.
Ophthalmic · 241d
Cleared Jun 20, 2008
CERAMENT BONE VOID FILLER, MODEL A0210
K073316 · MQV
Bonesupport AB
Orthopedic · 207d
Cleared Jun 20, 2008
FREEDOM SCIENCES MOTION CONTROL MODULE (MCM)
K073330 · ITI
Freedom Sciences, LLC
Physical Medicine · 206d
Cleared Jun 20, 2008
PATIENT CABLE
K080112 · DSA
Med-Dyne
Cardiovascular · 156d
Cleared Jun 20, 2008
PALOMAR LUX 1540 HANDPIECE
K080244 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 141d
Cleared Jun 20, 2008
APEXPRO TELEMETRY SYSTEMS
K080251 · MHX
Ge Medical Systems Information...
Cardiovascular · 141d