15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEUROMED ELECTROANALGESIC DELIVERY SYSTEMS
FDA 510(k)
FDA Class 2
·Neurology
Clear Readers
FDA UDI
Diversified Products, Inc.·00842894127827·
NOBELACTIVE INTERNAL RP 4.3X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 17, 2020
NOBELACTIVE INTERNAL NP 3.5X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·September 9, 2020
NOBELACTIVE INTERNAL NP 3.5X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·September 9, 2020
NOBELACTIVE INTERNAL RP 4.3X8.5MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·August 17, 2020
GORE-TEX VASCULAR GRAFT; GORE-TEX STRETCH VASCULAR GRAFT
FDA 510(k)
FDA Class 2
·Cardiovascular
FMP METAL/METAL ACETABULAR INSERT
FDA 510(k)
FDA Class 3
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2025
CRE? WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KOG·April 29, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 13, 2011
*
FDA Adverse Event
Product code GEI·July 29, 2008
BARRX
FDA Adverse Event
Injury
·COVIDIEN LP BARRX·Product code GEI·April 7, 2021
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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