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

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RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES

FDA 510(k)
FDA Class 2 ·Cardiovascular

ELEC-MATE E

FDA 510(k)
FDA Class 1 ·Dental

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 27, 2006

R90 SPACERS

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC INC.·Product code MQP·October 9, 2009

R90 SPACERS

FDA Adverse Event
Other ·WARSAW ORTHOPEDIC INC·Product code MAX·November 6, 2009

R90 SPACERS

FDA Adverse Event
Injury ·SOFAMOR DANEK DEGGENDORF GMBH·Product code MAX·December 21, 2009

EON

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 28, 2013

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·March 28, 2011

M SERIES

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 17, 2008

R90 SPACER

FDA Adverse Event
Malfunction ·MSD DEGGENDORF MFG·Product code NKB·August 5, 2011

Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

FDA Enforcement
Class II ·Terminated·Unomedical As·July 1, 2015

Spirit Plus Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

Spirit Select Bed, A-C Powered Hospital Bed

FDA Enforcement
Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

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

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013