13 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
FDA 510(k)
FDA Class 2
·Orthopedic
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 11, 2013
PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 27, 2008
ASR ACETABULAR IMPLANT 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 7, 2011
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·June 11, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·May 28, 2022
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 22, 2021
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 2012
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·August 8, 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