14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Clear Guide SCENERGY
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
Synthes GmbH·10886982143266·2.0MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...
OsteoMed
FDA UDI
OSTEOMED LLC·00842528125588·1.6mm Rainbow Drill, Long Cannula
VASOTRAX
FDA 510(k)
FDA Class 2
·Cardiovascular
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Widex
FDA UDI
Widex A/S·05706069773774·Widex EVOKE E-FS, Telecoil, RC coil
LINER: MPACT FLAT PE HC LINER Ø28/B
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 16, 2023
ACRYSOF MULTIPIECE IOL
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. - HUNTINGTON·Product code HQL·June 6, 2018
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 17, 2014
COMP RVS CNTRL SCR 6.5X25MM ST
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWS·July 2, 2013
KYPHON XPEDE
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NDN·June 22, 2021
HEARTWARE VENTRICULAR ASSIST SYSTEM-PUMP
FDA Adverse Event
Injury
·HEARTWARE, INC.·Product code DSQ·May 1, 2018
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