19 results · 21ms · Sources: EU EUDAMED, 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