25 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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D2RF DIGITAL DYNAMIC REMOTE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383502573·Gutta Percha Points is used to root canal filin...
BD DIRECTIGEN EZ FLU A+B ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
ROK
FDA 510(k)
FDA Class 2
·Dental
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973677·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970072·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970102·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970089·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970119·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970034·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970096·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973004·
TERUMO PERFUSION SYSTEM 8000
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 2, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 19, 2014
DUAL COOLER/HEATER
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DWC·May 20, 2011
BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·Product code FOZ·June 25, 2021
DYNAFORCE
FDA Adverse Event
Malfunction
·CROSSROADS EXTREMITY SYSTEMS·Product code JDR·September 29, 2022
GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 3+ RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 12, 2017
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
Model Number L211 PROPONENT DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025