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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
37297–37320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2014
IKNEE DISTAL FEMORAL CUTTING GUIDE
K140689 · OLO
Evergreen Orthopedic Research Lab
Orthopedic · 156d
Cleared Aug 22, 2014
1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER,...
K140944 · MCW
Atheromed, Inc.
Cardiovascular · 130d
Cleared Aug 22, 2014
COMPACTCATH INTERMITTENT URINARY CATHETER
K140945 · EZD
Compactcath, Inc.
Gastroenterology & Urology · 130d
Cleared Aug 22, 2014
NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE
K140946 · MQV
Novabone Products, LLC
Orthopedic · 130d
Cleared Aug 22, 2014
CONSTELLATION VISION SYSTEM
K141065 · HQE
Alcon Research, Ltd.
Ophthalmic · 120d
Cleared Aug 22, 2014
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR
K141083 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 116d
Cleared Aug 22, 2014
VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE
K141288 · GEI
Applied Medical Resources
General & Plastic Surgery · 98d
Cleared Aug 22, 2014
MERCURY SPINAL SYSTEM
K141372 · NKB
Spinal Elements, Inc.
Orthopedic · 87d
Cleared Aug 22, 2014
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III...
K141446 · GWJ
Natus Medical Incorporated
Neurology · 81d
Cleared Aug 22, 2014
CVI42
K141480 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 79d
Cleared Aug 22, 2014
ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
K141509 · PGM
Medos Sarl
Orthopedic · 77d
Cleared Aug 22, 2014
MUSTANG BALLOON DIALATION CATHETER
K141597 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 70d
Cleared Aug 22, 2014
VAPRO INTERMITTENT CATHETER
K141642 · GBM
Hollister Incorporated
Gastroenterology & Urology · 64d
Cleared Aug 22, 2014
BREAST SPEEDER CX, GRID HOLDER CX
K142002 · MOS
Quality Electrodynamics, LLC
Radiology · 30d
Cleared Aug 22, 2014
X-PORTE ULTRASOUND SYSTEM
K142017 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d
Cleared Aug 21, 2014
IONSIL GEL
K132326 · FRO
Virchow Biotech Pvt, Ltd.
General & Plastic Surgery · 391d
Cleared Aug 21, 2014
ALARIS SYSTEM WITH GUARDRAILS SUITE MX
K133532 · FRN
Carefusion 303, Inc.
General Hospital · 276d
Cleared Aug 21, 2014
GEKO
K133638 · IPF
Firstkind Limited
Physical Medicine · 267d
Cleared Aug 21, 2014
ZL MICRODENT NATURAL LOCK IMPLANT SYSTEM
K133706 · DZE
Zl Microdent-Attachment GmbH & Co. KG
Dental · 261d
Cleared Aug 21, 2014
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
K140028 · DYB
Galt Medical Corp.
Cardiovascular · 227d
Cleared Aug 21, 2014
SB ANCHOR
K140600 · NHA
Osstem Implant Co., Ltd.
Dental · 164d
Cleared Aug 21, 2014
BELTER INFRA-RED EAR THERMOMETER
K140681 · FLL
Shenzhen Belter Health Measurement...
General Hospital · 156d
Cleared Aug 21, 2014
INTRAOSSEOUS FIXATION SYSTEM
K141004 · HTY
Orthohelix Surgical Designs, Inc.
Orthopedic · 125d
Cleared Aug 21, 2014
MEDLINE ANTI-EMBOLISM STOCKING
K141127 · DWL
Medline Industries, Inc.
General Hospital · 112d