14 results · 24ms · Sources: EU EUDAMED, US FDA

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DEPUY GLOBAL SHOULDER CROSSLINK GLENOID

FDA 510(k)
FDA Class 2 ·Orthopedic

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·24026704284331·BECKMAN RETRACTOR 12 1/4" 4X4 BLUNT

KMEDIC

FDA UDI
TELEFLEX INCORPORATED·14026704920829·

DELTA 32 AND DELTA 32 TACT

FDA 510(k)
FDA Class 2 ·Radiology

A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS

FDA 510(k)
FDA Class 2 ·Cardiovascular

INNOVA 4100

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

INNOVA 4100

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·September 3, 2010

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 11, 2013

ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION CORPORATION·Product code FRN·March 15, 2011

CONV PN SEC MACRO OL

FDA Adverse Event
Malfunction ·HOSPIRA, LTD·Product code FPA·May 22, 2008

FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

FDA Enforcement
Class II ·Terminated·BioFire Diagnostics, LLC·April 24, 2019

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