11 results
·
34ms
·
Sources: EU EUDAMED, US FDA
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Nice-Temp™ Temporary Material
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310238803·Safco Temp A1 refill pack
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
FDA 510(k)
FDA Class 2
·Cardiovascular
DAYLITE XENON LIGHT SOURCES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD INTERLINK¿ BLUNT PLASTIC CANNULA
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·September 24, 2018
3.2MMX40MM RNGLC+ ACET DRL BIT
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HTW·August 7, 2019
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYE·March 27, 2013
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Death
·W.L. GORE & ASSOCIATES·Product code MIH·March 14, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·April 4, 2008
ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code DHA·January 7, 2012
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