14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
FDA 510(k)
FDA Class 2
·Cardiovascular
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
FDA 510(k)
FDA Class 2
·Orthopedic
LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2025
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·May 6, 2010
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·November 5, 2010
PRISMAFLEX
FDA Adverse Event
Injury
·GAMBRO LUNDIA AB·Product code KDI·November 25, 2010
DRB1 SSP UNITRAY KIT WITH TAQ POLYMERASE
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORP·Product code MZI·January 23, 2014
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·April 29, 2013
ADAPTA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·May 10, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 29, 2008
VERSAFITCUP DM ACETABULAR SHELL Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 24, 2015
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