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
78049–78072 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2001
STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G
K012856 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 84d
Cleared Nov 16, 2001
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
K012880 · KGO
Ssn Gloves (M) Sdn Bhd
General Hospital · 80d
Cleared Nov 16, 2001
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200...
K012896 · KGO
Ssn Gloves (M) Sdn Bhd
General Hospital · 80d
Cleared Nov 16, 2001
MEDSTAR 100 INTERFERENTIAL STIMLATOR
K013082 · LIH
Mednet Services, Inc.
Neurology · 63d
Cleared Nov 16, 2001
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
K013095 · CEO
Wiener Laboratories Saic
Chemistry · 60d
Cleared Nov 16, 2001
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA...
K013101 · JFJ
Wiener Laboratories Saic
Chemistry · 60d
Cleared Nov 16, 2001
VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
K013119 · JJX
Maine Standards Co.
Chemistry · 59d
Cleared Nov 16, 2001
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
K013203 · NBW
Polymer Technology Systems, Inc.
Chemistry · 52d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013206 · DFC
Roche Diagnostics Corp.
Chemistry · 52d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
K013249 · DER
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 16, 2001
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
K013274 · NEW
Cp Medical
General & Plastic Surgery · 46d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013440 · MNI
Scien'Tx USA, Inc.
Orthopedic · 30d
Cleared Nov 16, 2001
ISOLA POLYAXIAL WASHER
K013441 · KWP
Depuyacromed
Orthopedic · 30d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013444 · MNH
Scien'Tx USA, Inc.
Orthopedic · 30d
Cleared Nov 16, 2001
LONG LENGTH DYAX NAIL
K013468 · HSB
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Nov 16, 2001
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K013480 · DTZ
Cobe Cardiovascular, Inc.
Cardiovascular · 28d
Cleared Nov 16, 2001
DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
K013499 · GEX
Diomed, Inc.
General & Plastic Surgery · 25d
Cleared Nov 16, 2001
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
K013503 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 25d
Cleared Nov 16, 2001
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
K013557 · MBI
Walter Lorenz Surgical, Inc.
Orthopedic · 23d
Cleared Nov 16, 2001
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM
K013627 · IYN
Medison America, Inc.
Radiology · 11d
Cleared Nov 16, 2001
HILL-ROM PRIMAVIEW MONITOR SYSTEM
K013709 · FET
Hill-Rom, Inc.
Gastroenterology & Urology · 8d
Cleared Nov 15, 2001
DIMENSION HAIC ASSAY, MODEL DF105
K011852 · LCP
Dade Behring, Inc.
Chemistry · 156d
Cleared Nov 15, 2001
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY...
K012544 · JCT
Vascular Architects, Inc.
General & Plastic Surgery · 100d
Cleared Nov 15, 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 91d