19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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JAS CALCIUM (ARSENAZO) REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009659·Zirlux 16+ B3 100X10
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304073641·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304073658·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304073634·
READERS.COM
FDA UDI
FGX INTERNATIONAL INC.·00192304073627·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112410·Awl Tap, 4.5 mm, Fixed Sleeve
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 27, 2021
SATURN BLOOD GLUCOSE MONITORING TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FREELITE KAPPA FREE KIT
FDA 510(k)
FDA Class 2
·Immunology
STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·April 6, 2025
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·July 23, 2010
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·March 19, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 4, 2011
ENDURON 10D 54OD X 28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HRY·March 11, 2008
OMNILINK ELITE PERIPHERAL STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIO·July 17, 2015
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
FDA Enforcement
Class II
·Terminated·Abbott Vascular·February 22, 2017
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014