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

Filters: Cleared only ×
176,076 results
78961–78984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2001
PROPAQ ENCORE MODELS 202, 204, 206
K012451 · DRT
Welch Allyn Protocol, Inc.
Cardiovascular · 19d
Cleared Aug 20, 2001
MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
K012478 · CHL
I-Stat Corp.
Chemistry · 18d
Cleared Aug 17, 2001
ITI DENTAL IMPLANT SYSTEM
K003552 · DZE
Institut Straumann SA
Dental · 273d
Cleared Aug 17, 2001
SPEEDYBELL
K010735 · KNW
Biopsybell S.A.S.
Gastroenterology & Urology · 158d
Cleared Aug 17, 2001
22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022
K011575 · KNW
Imagyn Surgical
Gastroenterology & Urology · 87d
Cleared Aug 17, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 32d
Cleared Aug 17, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
K012280 · HWC
Triage Medical, Inc.
Orthopedic · 29d
Cleared Aug 17, 2001
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455 · DXQ
Welch Allyn, Inc.
Cardiovascular · 16d
Cleared Aug 17, 2001
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
K012461 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 16d
Cleared Aug 17, 2001
GSIBP BLOOD PRESSURE CUFF
K012553 · DXQ
Globalshop, Inc.
Cardiovascular · 9d
Cleared Aug 16, 2001
VERTEX SEALAND L/C ORTHODONTIC SEALANT
K010547 · KLE
Apex Dental Materials, Inc.
Dental · 174d
Cleared Aug 16, 2001
AIA-PACK BRCA, ST AIA PACK BRCA
K010796 · MOI
Tosoh Medics, Inc.
Immunology · 153d
Cleared Aug 16, 2001
AQUASENS FLUID MONITORING SYSTEM
K011069 · HIG
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 129d
Cleared Aug 16, 2001
HELIOSEAL CLEAR CHROMA
K011491 · EBC
Ivoclar North America, Inc.
Dental · 93d
Cleared Aug 16, 2001
INFANT OXYGEN TREATMENT HOOD
K011565 · CBF
Gulf Coast Hyperbarics, Inc.
Anesthesiology · 87d
Cleared Aug 16, 2001
HORIZONS INTERNATIONAL POLYPECTOMY SNARES
K011667 · FDI
Horizons Intl. Corp.
Gastroenterology & Urology · 78d
Cleared Aug 16, 2001
SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
K011765 · LZA
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 70d
Cleared Aug 16, 2001
MODIFICATION TO ENVOY PATIENT MONITOR
K011784 · DSI
Mennen Medical , Ltd.
Cardiovascular · 69d
Cleared Aug 16, 2001
FUTURA TOPCAP NON GAMMA-2
K011801 · EJJ
Ab Ardent
Dental · 69d
Cleared Aug 16, 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 48d
Cleared Aug 16, 2001
IMAGINE H.E.
K012156 · EIH
Wieland Edelmetalle GmbH & Co.
Dental · 36d
Cleared Aug 16, 2001
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS...
K012242 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Aug 16, 2001
PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM
K012379 · IZL
Trex Enterprises Corp.
Radiology · 21d
Cleared Aug 16, 2001
ABN ANEROID SPHYGMOMANOMETER
K012444 · DXQ
Pt. Sugih Instrumendo Abadi
Cardiovascular · 15d