21 results · 24ms · Sources: EU EUDAMED, 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