FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
78361–78384 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 15, 2001
3T L. V. CONTROL VALVE
K001245 · MJJ
3t Medical Systems, LLC
Cardiovascular · 484d
Cleared Aug 15, 2001
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL...
K002992 · IKT
Medtronic Functional Diagnostics A/S
Neurology · 324d
Cleared Aug 15, 2001
NURSE'S ASSISTANT O.R. CONTROL SYSTEM
K010754 · GCJ
Valmed Corp.
General & Plastic Surgery · 155d
Cleared Aug 15, 2001
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
K011210 · JOH
Rusch Intl.
Anesthesiology · 118d
Cleared Aug 15, 2001
AMEDA HYGIENIKIT
K011519 · HGY
Hollister, Inc.
Obstetrics & Gynecology · 90d
Cleared Aug 15, 2001
HADGEL, 4 GRAM/SYRINGE
K011544 · LYA
Seikagaku Corp.
Ear, Nose, Throat · 89d
Cleared Aug 15, 2001
VHS PEDIATRIC HIP SCREW SYSTEM
K011603 · KTT
Walter Abendschein, M.D.
Orthopedic · 83d
Cleared Aug 15, 2001
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
K011679 · POV
Embryotech Laboratories, Inc.
Hematology · 77d