14 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
FDA 510(k)
FDA Class 3
·Cardiovascular
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057370663·STRETCHER PAD 28" W X 3.5" H X 78" L STANDARD
MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
RAINBOW R1 25L SENSOR
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·June 19, 2015
AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·May 30, 2023
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·April 26, 2013
STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 21, 2011
PREMIUM SURGICLIP M-11.5 TITANIUM
FDA Adverse Event
Injury
·PONCE- USS·Product code GDO·July 23, 2008
AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 25, 2022
AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 20, 2023
L.C. 5000/CE 2-CHANNEL PUMP (50/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FPA·August 22, 2013
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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