9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 5, 2024
BONUS MECHANICAL WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
HF MODULE WITH TRANSDUCERS
FDA 510(k)
FDA Class 2
·Radiology
SYNFRAME GUIDE ROD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 22, 2013
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 13, 2011
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·July 3, 2008
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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