21 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GLOBAL FX POROUS-COATED HUMERAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040013687·Zirlux 16+ C2 98.5X16
MEGA PLUS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809763501937·Dual Locking Wrench
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K01109N0·Cervical Trial, 14 x 11, 9mm, 0 Degree, No Taper
ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PJUR EROS WATER FORMULATION
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 1, 2006
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQY·March 27, 2007
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code DQY·December 28, 2006
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code DQY·March 5, 2007
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 28, 2006
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 27, 2012
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MNI·April 16, 2013
ULTRA-THIN SDS BALLOON CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORP.·Product code DQY·April 12, 2007
BREG POST-OP SHOE
FDA Adverse Event
Malfunction
·BREG, INC.·Product code IQI·March 19, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·March 8, 2011
TENDRIL SDX
FDA Adverse Event
Injury
·TELECTRONICS PACING SYSTEMS·Product code DTB·March 10, 2008
TECA CONCENTRIC NEEDLES
FDA Adverse Event
Malfunction
·NATUS MANUFACTURING LIMITED·Product code IKT·January 2, 2024
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