11 results · 34ms · Sources: EU EUDAMED, US FDA

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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