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
50425–50448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 14, 2010
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
K100271 · HRS
Howmedica Osteonics Corp.
Orthopedic · 105d
Cleared May 14, 2010
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K100294 · LYZ
Zibo Yinghao Medical Products Co., Ltd.
General Hospital · 101d
Cleared May 14, 2010
COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
K100521 · JOW
Mego Afek AC , Ltd.
Cardiovascular · 80d
Cleared May 14, 2010
ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION...
K100704 · FRN
Disetronic Medical Systems AG
General Hospital · 63d
Cleared May 14, 2010
COCR RODS
K100788 · NKB
Globus Medical, Inc.
Orthopedic · 53d
Cleared CT May 13, 2010
LENSAR LASER SYSTEM
K090633 · OOE
Lensar, Inc.
Ophthalmic · 430d
Cleared May 13, 2010
TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL...
K092164 · OQQ
Shenzhen Delicate Electronics Co., Ltd.
Radiology · 301d
Cleared May 13, 2010
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
K093123 · FTL
Biomerix Corporation
General & Plastic Surgery · 223d
Cleared May 13, 2010
BABI PLUS INFANT NASAL CANNULA SYSTEM
K093716 · BZD
A Plus Medical
Anesthesiology · 162d
Cleared May 13, 2010
SYNTHES T-PAL SPACER
K100089 · MAX
Synthes Spine
Orthopedic · 121d
Cleared May 13, 2010
DIAMOND ANTERIOR CERVICAL PLATE SYSTEM
K100265 · KWQ
Amendia, Inc.
Orthopedic · 104d
Cleared May 13, 2010
SPINEWAND SURGICAL DEVICE
K100353 · GEI
Arthrocare Corp.
General & Plastic Surgery · 90d
Cleared May 13, 2010
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM...
K100433 · LKQ
Siemens Healthcare Diagnostics
Microbiology · 86d
Cleared May 13, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100697 · LYZ
Shijiazhuang Universal Channel...
General Hospital · 63d
Cleared May 13, 2010
LEGION POROUS + HA TIBIAL BASEPLATES
K100897 · MBH
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared May 13, 2010
VARIAX ELBOW SYSTEM
K101056 · HRS
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared May 12, 2010
MINXRAY, MODEL: BPD60
K091255 · EHD
Minxray, Inc.
Radiology · 378d
Cleared May 12, 2010
EASYCELL CELL LOCATOR
K092116 · JOY
Medica Corp.
Hematology · 302d
Cleared May 12, 2010
NAVIGATOR CLINICAL GUIDENCE SYSTEM
K092219 · DXG
Applied Physiology Pty , Ltd.
Cardiovascular · 294d
Cleared May 12, 2010
MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER...
K092586 · HIS
Innolatex (Thailand) Limited
Obstetrics & Gynecology · 261d
Cleared May 12, 2010
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
K092789 · GCJ
Terumo Cardiovascular Systems Corp.
General & Plastic Surgery · 244d
Cleared May 12, 2010
BWF-5 MEDICAL LASER SERIES
K093087 · GEX
Litecure, LLC
General & Plastic Surgery · 223d
Cleared May 12, 2010
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · DKZ
Microgenics Corp.
Chemistry · 223d
Cleared May 12, 2010
PLANMECA PROMAX 3D MAX
K093590 · MUH
Planmeca Oy
Radiology · 174d