15 results · 21ms · Sources: EU EUDAMED, 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