11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
SHOWER MINI RD-7 SANITARY WASHER
FDA 510(k)
FDA Class 2
·Physical Medicine
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK
OEC(R) 9800, OEC(R) 9800 PLUS
FDA 510(k)
FDA Class 2
·Radiology
SURE CHECK PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROTASUL-S-30-HEAD 28 L
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·May 27, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
CUB CRIB
FDA Adverse Event
STRYKER MEDICAL QUEBEC, LP·Product code FMS·November 22, 2010
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·July 31, 2024
VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code LQM·January 24, 2018
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177. Used with vascular catheter. Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 31, 2016