10 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
JOE LUBE CONDOM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ENDOVASCULAR GUIDE WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC.·Product code DYB·March 29, 2024
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 19, 2021
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 26, 2013
ZERO PROFILE TWO-LEVEL ACP SIZE 32MM
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code NKB·April 29, 2011
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 24, 2008
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015