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
45505–45528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 04, 2012
BIGBOSS CATHETER
K113589 · DQY
Bridgepoint Medical
Cardiovascular · 30d
Cleared Jan 04, 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
K113609 · LPH
Exactech, Inc.
Orthopedic · 29d
Cleared Dec 30, 2011
STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
K111068 · KYI
Skeletal Dynamics, LLC
Orthopedic · 256d
Cleared Dec 30, 2011
HANAROSTENT BILIARY (NNN)
K111149 · FGE
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 249d
Cleared Dec 30, 2011
MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES
K111403 · DQA
Masimo Corporation
Anesthesiology · 225d
Cleared Dec 30, 2011
MYOGUIDE SYSTEM MODEL 8008
K111985 · BXN
Intronix Technologies Corp.
Anesthesiology · 171d
Cleared Dec 30, 2011
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
K112522 · FGE
Flexible Stenting Solutions, Inc.
Gastroenterology & Urology · 121d
Cleared Dec 30, 2011
FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES
K112944 · INO
Fresenius Medical Care South Asia...
Physical Medicine · 87d
Cleared Dec 30, 2011
VISIA DYNAMIC REVIEW
K113337 · LNH
Mevis Medical Solutions AG
Radiology · 46d
Cleared Dec 30, 2011
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
K113373 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 44d
Cleared Dec 29, 2011
TRIMOTION INJECTOR
K102999 · OTZ
Kaneka Corp.
Ophthalmic · 447d
Cleared Dec 29, 2011
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY...
K112543 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 119d
Cleared Dec 29, 2011
SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING
K112778 · IYE
Varian Medical Systems
Radiology · 94d
Cleared Dec 29, 2011
VPAP TX
K112914 · MNS
Resmed, Ltd.
Anesthesiology · 87d
Cleared Dec 29, 2011
ELITTECH CLINICAL SYSTEMS ALP IFCC SL
K113269 · CJE
Elitechgroup
Chemistry · 55d
Cleared Dec 29, 2011
SOMATOM DEFINITION FLASH
K113342 · JAK
Siemens Medical Systems, Inc.
Radiology · 45d
Cleared Dec 29, 2011
MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM
K113381 · IYN
Samsung Medison Co., Ltd.
Radiology · 43d
Cleared Dec 29, 2011
LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS
K113559 · ODP
Ldr Spine USA, Inc.
Orthopedic · 28d
Cleared Dec 29, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
K113630 · MQB
Rayence Co., Ltd.
Radiology · 21d
Cleared Dec 29, 2011
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
K113680 · IYO
Soma Access Systems, LLC
Radiology · 14d
Cleared Dec 29, 2011
GE LOGIQ I, LOGIQ E AND VIVID E
K113690 · IYN
Ge Healthcare
Radiology · 14d
Cleared Dec 28, 2011
ARTS2 SPINAL FIXATION SYSTEM
K103573 · MNH
Advanced Medical Technologies
Orthopedic · 387d
Cleared Dec 28, 2011
ENDOWRIST ONE VESSEL SEALER
K110639 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 299d
Cleared Dec 28, 2011
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
K111618 · EWO
Natus Medical Incorporated
Ear, Nose, Throat · 201d