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
61969–61992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 2006
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
K061269 · GXY
Excel Tech. , Ltd.
Neurology · 101d
Cleared Aug 14, 2006
ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
K061463 · DRF
Biosense Webster, Inc.
Cardiovascular · 80d
Cleared Aug 14, 2006
REFSTAR EXTERNAL REFERENCE PATCH
K061468 · DRF
Biosense Webster, Inc.
Cardiovascular · 80d
Cleared Aug 14, 2006
VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
K061483 · FMI
Greiner Bio-One North America, Inc.
General Hospital · 76d
Cleared Aug 14, 2006
PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE...
K061610 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 66d
Cleared Aug 14, 2006
PRESTIGE AMERITECH FACE MASK
K061716 · FXX
Prestige Ameritech
General Hospital · 56d
Cleared Aug 14, 2006
ARM BLOOD PRESSURE MONITOR, MODEL KP-7600
K061760 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 53d
Cleared Aug 14, 2006
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
K061885 · JIT
Dade Behring, Inc.
Chemistry · 42d
Cleared Aug 14, 2006
VERTE-STACK SPINAL SYSTEM
K062073 · MQP
Medtronic Sofamor Danek
Orthopedic · 24d
Cleared Aug 11, 2006
SAFETY SYRINGE
K053519 · MEG
Wuxi Yushou Medical Applicances Co.,...
General Hospital · 235d
Cleared Aug 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
K060620 · NBW
Roche Diagnostics Corp.
Chemistry · 156d
Cleared Aug 11, 2006
COAGUCHEK XS SYSTEM
K060978 · GJS
Roche Diagnostics
Hematology · 123d
Cleared Aug 11, 2006
BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003
K061099 · BZD
Hoffman Laboratories, LLC
Anesthesiology · 114d
Cleared Aug 11, 2006
STRAUMANN DENTAL IMPLANTS
K061176 · DZE
Institut Straumann AG
Dental · 106d
Cleared Aug 11, 2006
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)
K061332 · NFA
Boston Scientific Corp
Cardiovascular · 91d
Cleared Aug 11, 2006
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40
K061451 · KYI
Ascension Orthopedics, Inc.
Orthopedic · 78d
Cleared Aug 11, 2006
MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS
K061477 · NHA
Nobel Biocare AB
Dental · 73d
Cleared Aug 11, 2006
TRIATHLON METAL BACKED PATELLA
K061521 · MBH
Howmedica Osteonics Corp.
Orthopedic · 70d
Cleared Aug 11, 2006
ACON URINALYSIS REAGENT STRIPS
K061559 · CDM
Acon Laboratories Co.
Chemistry · 67d
Cleared Aug 11, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061579 · KWP
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Aug 11, 2006
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS
K061707 · MKJ
Philips Medical Systems
Cardiovascular · 56d
Cleared Aug 11, 2006
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
K061750 · JIX
Dade Behring, Inc.
Chemistry · 51d
Cleared Aug 11, 2006
JOSTRA HLM TUBING SETS WITH SAFELINE COATING
K061832 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 43d
Cleared Aug 11, 2006
NEURO II-SE, MODELS OR-MB-DR AND OR-DR
K061916 · LNH
Imris, Inc.
Radiology · 36d