15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NaturalLine Abutment
FDA 510(k)
FDA Class 2
·Dental
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837087722·
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869607759·TELIX K Ti Cage 14x32mm 5°
EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FLEXIBLE SILICONE DRILL DRIVER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HTW·March 12, 2018
FLEXIBLE SILICONE DRILL DRIVER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code HTW·March 12, 2018
GREENLIGHT HPS BPH FIBER OPTIC
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 30, 2013
4R ELEV.
FDA Adverse Event
Malfunction
·INTEGRA, YORK - IMILTEX·Product code EMJ·June 21, 2011
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·September 5, 2008
Precise Digital Accelerator Delivery of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 26, 2012
Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 20, 2013
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 12, 2014