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
77425–77448 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 23, 2002
VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)
K011625 · DXN
Vasocor, Inc.
Cardiovascular · 243d
Cleared Jan 23, 2002
EXEL COMFORTPOINT INSULIN PEN NEEDLE
K011757 · FMI
Exelint Intl. Co.
General Hospital · 231d
Cleared Jan 23, 2002
BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE
K011967 · FOZ
Bd
General Hospital · 212d
Cleared Jan 23, 2002
INTRAORAL LENS OPTION TO SPECTROSHADE
K012744 · EIA
Mht Optic Research AG
Dental · 160d
Cleared Jan 23, 2002
PORTABLE INTENSIVE CARE UNIT
K012766 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 159d
Cleared Jan 23, 2002
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO...
K013303 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 111d
Cleared Jan 23, 2002
SCI-PHARM POST SECURE
K013555 · EMA
Scientific Pharmaceuticals, Inc.
Dental · 90d
Cleared Jan 23, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K013558 · KWQ
Blackstone Medical, Inc.
Orthopedic · 90d
Cleared Jan 23, 2002
PRECISION PLUS TUNA OFFICE SYSTEM
K014224 · GEI
Vidamed, Inc.
General & Plastic Surgery · 28d
Cleared Jan 23, 2002
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING...
K020019 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 20d
Cleared Jan 22, 2002
DIOMED 15 DIODE LASER
K012398 · GEX
Diomed, Ltd.
General & Plastic Surgery · 179d
Cleared Jan 22, 2002
VANGUARD REPROCESSED INFLATION DEVICES
K012480 · MAV
Vanguard Medical Concepts, Inc.
Cardiovascular · 173d
Cleared Jan 22, 2002
CROSSTEX ISOLITE EARLOOP FACE MASKS-BLUE, PINK, CROSSTEX ISOFLUID EARLOOP...
K012602 · FXX
Crosstex Intl.
General Hospital · 162d
Cleared Jan 22, 2002
UNIGLOVE LANO-E POWDER-FREE LATEX EXAMINATION GLOVES
K013163 · LYY
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 123d
Cleared Jan 22, 2002
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K013262 · LYY
Great Glove (Thailand) Co. , Ltd.
General Hospital · 113d
Cleared Jan 22, 2002
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
K013465 · LCP
Diabetes Technologies, Inc.
Hematology · 96d
Cleared Jan 22, 2002
PUMP TUBING
K013578 · DWE
Terumo Cardiovascular Systems Corp.
Cardiovascular · 85d
Cleared Jan 22, 2002
BODY ARRAY COIL
K013594 · MOS
Usa Instruments, Inc.
Radiology · 84d
Cleared Jan 22, 2002
PREMIER III PHASED ARRAY CTL SPINE COIL
K013595 · MOS
Usa Instruments, Inc.
Radiology · 84d
Cleared Jan 22, 2002
MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
K013620 · IZF
Medstone Intl., Inc.
Radiology · 78d
Cleared Jan 22, 2002
WEINMANN SOMNOMASK
K013738 · BZD
Gottlieb Weinmann Geraete Fuer...
Anesthesiology · 70d
Cleared Jan 22, 2002
V-GNATHOS SUPRA
K013769 · EJT
Metalor Technologies USA
Dental · 70d
Cleared Jan 22, 2002
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN...
K013793 · LYY
Shen Wei (Usa), Inc.
General Hospital · 69d
Cleared Jan 22, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE AND PROTEIN CLAIM, TESTED FOR...
K013794 · LYY
Shen Wei (Usa), Inc.
General Hospital · 69d