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
46585–46608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 2011
IP TEMP CEMENT
K111685 · EMA
Shofu Dental Corporation
Dental · 78d
Cleared Sep 02, 2011
AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS
K111810 · MLR
STERIS Corporation
General Hospital · 67d
Cleared Sep 02, 2011
MICROSUTURE ANCHORS
K112237 · HWC
Arthrex, Inc.
Orthopedic · 29d
Cleared Sep 02, 2011
DIGITAL RADIOGRAPHY
K112309 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 22d
Cleared Sep 01, 2011
VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION...
K103331 · JOJ
STERIS Corporation
General Hospital · 293d
Cleared CT Sep 01, 2011
ROMA (HE4 EIA + ARCHITECT CA 125 II)
K103358 · ONX
Fujirebio Diagnostics,Inc.
Immunology · 289d
Cleared Sep 01, 2011
SAPPHIRE NC
K103808 · LOX
Orbusneich Medical, Inc.
Cardiovascular · 246d
Cleared Sep 01, 2011
MEDIPLUS-FOAM AG
K110062 · FRO
Medipurpose Pte. , Ltd.
General & Plastic Surgery · 234d
Cleared Sep 01, 2011
ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE
K110565 · NHA
Biomet 3i, Inc.
Dental · 185d
Cleared Sep 01, 2011
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
K110729 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 169d
Cleared Sep 01, 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K110944 · LYZ
Wangda Plastic Co., Ltd.
General Hospital · 150d
Cleared Sep 01, 2011
GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
K111059 · HIN
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 136d
Cleared Sep 01, 2011
POLY-CHEM 90 TOTAL BILIRUBIN
K111143 · CIG
Polymedco, Inc.
Chemistry · 132d
Cleared Sep 01, 2011
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
K112199 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 31d
Cleared Sep 01, 2011
VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
K112213 · IYN
Ge Healthcare
Radiology · 30d
Cleared Sep 01, 2011
ALP 501 RB PUMP SYSTEM
K112311 · JOW
Currie Medical Specialties, Inc.
Cardiovascular · 21d
Cleared Sep 01, 2011
VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
K112349 · GCJ
Covidien, Formerly US Surgical A...
General & Plastic Surgery · 16d
Cleared Sep 01, 2011
EMG SUCTION UNIT
K112421 · JCX
Emg Technology Co., Ltd.
General & Plastic Surgery · 9d
Cleared Aug 31, 2011
MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL...
K101204 · CGA
Apex BioTechnology Corp.
Chemistry · 488d
Cleared Aug 31, 2011
TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE...
K101635 · NBW
Taidoc Technology Corporation
Chemistry · 447d
Cleared Aug 31, 2011
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G,...
K103747 · LBS
Elitechgroup Seppim S.A.S.
Chemistry · 251d
Cleared Aug 31, 2011
CMC CABLE FIX
K111032 · HTN
Instratek, Inc.
Orthopedic · 140d
Cleared Aug 31, 2011
MORPHEUS OX
K111314 · MNR
Widemed, Ltd.
Anesthesiology · 113d
Cleared Aug 31, 2011
MDRIVE
K111742 · MNR
Embla Systems
Anesthesiology · 71d