17 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Light Cure Dental Adhesive
FDA 510(k)
FDA Class 2
·Dental
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446885948·SPECIAL, RSP IM HUMERAL OSTEOTOMY GUIDE, SUPERI...
HHM
FDA UDI
Oticon A/S·05707131355195·G300 SC, MINIRITE 312 2.4G C079 HHM
QUART ARTERIAL FILTER, MODEL HBF 140
FDA 510(k)
FDA Class 2
·Cardiovascular
VISUCAM
FDA 510(k)
FDA Class 1
·Radiology
CONTOUR® PLUS BLUE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 12, 2026
GE OEC 6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008
M2A MAGNUM MODULAR HEAD
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code KWA·August 5, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 2, 2013
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 3, 2025
CONTOUR® CARE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 23, 2026
BD CATHENA¿ SAFETY IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·May 19, 2022
CONTOUR® NEXT
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 8, 2025
CONTOUR® PLUS ELITE
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 8, 2025
HLM TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTM·July 6, 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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021