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
50905–50928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 15, 2010
OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER
K093232 · DYB
Great Batch Medical
Cardiovascular · 152d
Cleared Mar 12, 2010
COAXIAL APPLICATOR SYSTEM
K091722 · FMF
Biomet, Inc.
General Hospital · 274d
Cleared Mar 12, 2010
VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS
K092265 · MEH
Medacta International S.A.
Orthopedic · 226d
Cleared Mar 12, 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
K092322 · LFX
Roche Diagnostics
Microbiology · 220d
Cleared Mar 12, 2010
C. ALBICANS/C. GLABRATA PNA FISH
K092784 · NZS
Advandx, Inc.
Microbiology · 183d
Cleared Mar 12, 2010
SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY...
K092922 · IYN
Sonoscape Company Limited
Radiology · 170d
Cleared Mar 12, 2010
SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
K092950 · DQA
Solaris Medical Technology, Inc.
Anesthesiology · 169d
Cleared Mar 12, 2010
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES
K093213 · HPT
Carl Zeiss Meditec, Inc.
Ophthalmic · 150d
Cleared Mar 12, 2010
VCARE DX
K093556 · LKF
Conmed Corporation
Obstetrics & Gynecology · 115d
Cleared Mar 12, 2010
ZR DENTAL BLOCK
K093571 · EIH
Ams Co., Ltd.
Dental · 114d
Cleared Mar 12, 2010
LIQUICHEK OPIATE CONTROL
K093577 · DIF
Bio-Rad Laboratories
Chemistry · 114d
Cleared Mar 12, 2010
ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED...
K093795 · FLL
Actherm, Inc.
General Hospital · 92d
Cleared Mar 12, 2010
LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
K093815 · OMG
Millipore Corporation
Microbiology · 88d
Cleared Mar 12, 2010
EZLASE 3 LASER SYSTEM
K093852 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 86d
Cleared CT Mar 12, 2010
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP...
K093881 · DQA
GE Healthcare Finland Oy
Anesthesiology · 84d
Cleared CT Mar 12, 2010
DIDGET WORLD REPORTS
K093930 · NBW
Bayer Healthcare, LLC
Chemistry · 80d
Cleared Mar 12, 2010
RAYSTATION VERSION 1.0
K100552 · MUJ
Raysearch Laboratories AB
Radiology · 14d
Cleared Mar 11, 2010
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L
K091656 · KDL
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 275d
Cleared Mar 11, 2010
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
K092181 · MID
Instrumentation Laboratory CO
Immunology · 233d
Cleared Mar 11, 2010
PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS
K092474 · KWQ
K2m, Inc.
Orthopedic · 211d
Cleared Mar 11, 2010
840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION
K092847 · CBK
Covidien, Formerly Nellcor Puritan...
Anesthesiology · 176d
Cleared Mar 11, 2010
SAVIEW 58 UV
K092852 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 176d
Cleared Mar 11, 2010
WELL LEAD ENDOBRONCHIAL TUBES
K092886 · CBI
Well Lead Instruments
Anesthesiology · 171d
Cleared Mar 11, 2010
PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
K092980 · LKF
Panpac Medical Corporation
Obstetrics & Gynecology · 164d