15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032903·Baltic Denture System BDLoad ↓ Lw6 PLSEum4DFl B...
ANSPACH ANGLED MICRONOSE ATTACHMENT
FDA 510(k)
FDA Class 2
·Neurology
CHILLBUSTER
FDA 510(k)
FDA Class 2
·Cardiovascular
TEGO® CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·August 20, 2019
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014
G7 DUAL MOBILITY LINER 46MM G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code OQG·February 8, 2022
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 3, 2013
CAPSURE Z NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 29, 2011
PLUM XLM PUMP
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·April 23, 2008
VIVACIT-E DM BEARING 28X46MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWY·February 8, 2022
CER BIOLOXD OPTION HD 28MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·February 8, 2022
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024