12 results · 23ms · Sources: EU EUDAMED, US FDA

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LIFENET EXCHANGE SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

GOLD CORE POST SOLDER

FDA 510(k)
FDA Class 2 ·Dental

RENAL GUIDING SHEATH

FDA 510(k)
FDA Class 2 ·Cardiovascular

NONE - SEE PHYSICIAN COMMENTS IN H10.

FDA Adverse Event
Injury ·Product code JWH·October 16, 2013

COLORADO 2 SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·January 22, 2009

COLORADO 2 SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 23, 2012

ELECTRODE, PACEMAKER, PERMANENT

FDA Adverse Event
Death ·MPRI·Product code DTB·April 11, 2013

PINN MAR NEUT 32IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·April 7, 2011

PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 27, 2008

TSRH SPINAL SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 24, 2016

Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

FDA Recall
Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

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