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
57937–57960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2007
STASILON FR
K072890 · QSY
Entegrion, Inc.
General & Plastic Surgery · 61d
Cleared Dec 10, 2007
LEGACY DENTAL IMPLANTS
K073033 · DZE
Implant Direct, LLC
Dental · 45d
Cleared Dec 10, 2007
PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
K073059 · LHN
Hitachi, Ltd., Power Systems Group
Radiology · 41d
Cleared Dec 10, 2007
VITEK 2 GRAM NEGATIVE PIPERACILLIN
K073083 · LON
bioMerieux, Inc.
Microbiology · 39d
Cleared Dec 07, 2007
ADVIA CHEMISTRY TOTAL BILIRUBIN_2
K063845 · JFM
Bayer Healthcare, LLC
Chemistry · 345d
Cleared Dec 07, 2007
AT HOME DRUG TEST MODELS, 9308T AND 9308X
K070009 · DIS
Phamatech, Inc.
Toxicology · 338d
Cleared Dec 07, 2007
ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0
K070021 · HRX
Jg Medical Products, LLC
Orthopedic · 338d
Cleared Dec 07, 2007
QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018
K070098 · DIS
Phamatech, Inc.
Toxicology · 331d
Cleared Dec 07, 2007
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY...
K070558 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 283d
Cleared Dec 07, 2007
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C....
K070582 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 281d
Cleared Dec 07, 2007
LIFE+CEL BATTERY
K071164 · MHX
Amco International Manufacturing &...
Cardiovascular · 225d
Cleared Dec 07, 2007
DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB
K071878 · GZJ
Med-Lectric Corporation
Neurology · 154d
Cleared Dec 07, 2007
STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
K072118 · NDN
Stryker Corp.
Orthopedic · 128d
Cleared Dec 07, 2007
AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB
K072137 · DXN
Avita Corporation
Cardiovascular · 127d
Cleared Dec 07, 2007
GUIDEWIRE, MODEL G-V220-3527S AND OTHERS
K072354 · OCY
Accellent, Inc.
Gastroenterology & Urology · 107d
Cleared Dec 07, 2007
COMPASS
K072374 · IYE
Scanditronix Wellhofer GmbH
Radiology · 106d
Cleared Dec 07, 2007
ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
K072393 · LSW
Phadia US, Inc.
Immunology · 102d
Cleared Dec 07, 2007
DM-EMG
K072513 · DWJ
Gvp Elettronica Srl
Cardiovascular · 92d
Cleared Dec 07, 2007
SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301
K072550 · KNT
Medevice, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 07, 2007
CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM
K072651 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 79d
Cleared Dec 07, 2007
HEMAWAY SEAT
K072690 · LRL
Hemaway, LLC
Gastroenterology & Urology · 74d
Cleared Dec 07, 2007
THE CROSSER SYSTEM
K072776 · PDU
Flowcardia, Inc.
Cardiovascular · 70d
Cleared Dec 07, 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K072840 · NKB
Endius, Inc.
Orthopedic · 64d
Cleared Dec 07, 2007
TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
K072892 · JJY
Biosite Incorporated
Chemistry · 58d