FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134953–134976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1988
LAITINEN'S TRIGEMINUS STEREOGUIDE
K881132 · HAW
Sandstrom Trade & Technology, Inc.
Neurology · 146d
Cleared Aug 09, 1988
IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM
K881342 · LJT
Burron Medical, Inc.
General Hospital · 132d
Cleared Aug 09, 1988
FIBRINOGENTEST-O
K881685 · GIS
Diatech, Inc.
Hematology · 112d
Cleared Aug 09, 1988
SCOPIX VIDEO IMAGER
K882096 · LMC
Agfa-Gevaert, Inc.
Radiology · 83d
Cleared Aug 09, 1988
FOLEY-TEMP(TM)
K882130 · EYB
Mallinckroot, Inc.
Gastroenterology & Urology · 81d
Cleared Aug 09, 1988
BATTLE CREEK PILLOW
K882264 · IQK
Battle Creek Equipment Co.
Physical Medicine · 70d
Cleared Aug 09, 1988
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
K882334 · CFR
Abbott Laboratories
Chemistry · 64d
Cleared Aug 09, 1988
DERMAPIK
K882360 · SCL
Creative Scientific Equipment Corp.
General Hospital · 63d
Cleared Aug 09, 1988
HEARING AID, UNITRON MODEL UI5
K882375 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 62d
Cleared Aug 09, 1988
MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE
K882448 · LJS
Bd Becton Dickinson Vacutainer...
General Hospital · 56d
Cleared Aug 09, 1988
X-RAY MARKER
K882519 · JAC
Karlin Technology, Inc.
Radiology · 53d
Cleared Aug 09, 1988
MONOJECT(R) SNAP-OVER SAFETY CAP
K882614 · JKA
Sherwood Medical Co.
Chemistry · 46d
Cleared Aug 09, 1988
INTERTECH LARGE VOLUME WATER TRAP (LVW)
K882739 · BYH
Intertech Resources, Inc.
Anesthesiology · 39d
Cleared Aug 09, 1988
SAFETY, BLOOD COLLECTION TUBE HOLDER
K882880 · FMI
Ryan Medical, Inc.
General Hospital · 29d
Cleared Aug 09, 1988
ELGILOY
K883074 · EBL
Dale T. Dupuis
Dental · 26d
Cleared Aug 08, 1988
VERIMED MYO/PREMS
K874212 · IPF
Verimed Holdings, Inc.
Physical Medicine · 297d
Cleared Aug 08, 1988
CLEAR EYE GARTER SHIELD
K880489 · HOY
Eye Garter Company, Inc.
Ophthalmic · 186d
Cleared Aug 08, 1988
SOLID PHASE EXTRACTION TUBES
K881361 · DJY
Supelco, Inc.
Toxicology · 174d
Cleared Aug 08, 1988
TELSTETH TELEMETRIC STETHOSCOPE(TM)
K882119 · DXH
Quantsonics, Inc.
Cardiovascular · 81d
Cleared Aug 08, 1988
COTUBE HCG IRMA TEST
K882155 · JHI
Bio-Rad
Chemistry · 80d
Cleared Aug 08, 1988
REVISED DOUBLE ANTIBODY AMPHETAMINE
K882228 · DJP
Diagnostic Products Corp.
Toxicology · 81d
Cleared Aug 08, 1988
MAGNESIUM REAGENT SET
K882256 · JGJ
Tech-Neal Scientific, Inc.
Chemistry · 69d
Cleared Aug 08, 1988
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
K882340 · CEP
Serono Diagnostics, Inc.
Chemistry · 62d
Cleared Aug 08, 1988
REP HDL ELECTROPHORESIS METHOD
K882368 · LBT
Helena Laboratories
Chemistry · 61d