11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vertos mild Device Kit (MDK-0002)
FDA 510(k)
FDA Class 2
·Orthopedic
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114292·SINSKEY IOL HOOK STR (BX/3)
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776365998·Alligator Max Grasping Frcp 3.5mm. 130mm WL
IdentiTi
FDA UDI
ALPHATEC SPINE, INC.·00190376367101·IdentiTi ALIF SA, T25 Removal Driver, Straight
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI
FDA 510(k)
FDA Class 2
·General Hospital
CAPIOX CARDIOTOMY RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
ASR UNI FEMORAL IMPL SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 4, 2011
TOTAL ASR FEM IMP SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·November 6, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
ACCESS HIGH SENSITIVITY TROPONIN I REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·January 13, 2023
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
FDA Enforcement
Class II
·Terminated·Epocal·August 21, 2013