16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771
FDA 510(k)
FDA Class 2
·Clinical Toxicology
LEONE SPA
FDA UDI
LEONE SPA·08033707065715·INTRAORAL ELASTICS 4,5 oz 5/16" blue
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702356984·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE/DOTTED SILIC...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702501445·ELVAREX 3/KNEE HIGH/PROFILE-CLOSED TOE-ELEPHANT...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702657098·ELVAREX FORTE 3/KNEE HIGH/SLANT-OPEN TOE-ELEPHA...
COALESCE
FDA UDI
VERTERA, INC.·B1422000000909000·9x23x9MM COALESCE-Straight, Parallel
STS-T LITHOTRIPTER, MODEL STS-T
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 2, 2019
MEDSTONE LITHOTRIPTOR
FDA Adverse Event
Malfunction
·HEALTHTRONICS, INC.·Product code LNS·June 12, 2017
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014
ALUMINA C-TAPER EHAD 36MM/+5
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code LZO·May 12, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 27, 2020
COBAS LIAT SYSTEM
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code OCC·April 21, 2021
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020