16 results · 24ms · Sources: EU EUDAMED, US FDA

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S12X WITH ESAX OPTION

FDA 510(k)
FDA Class 2 ·Neurology

SILMAX CONTOUR CARVING BLOCK IMPLANT

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ALWAYS DUETS

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

IMPL TAPERED SP 3.7MM 12M M OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

IMPL TAPERED SP 3.7MM 12M M OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 12, 2024

IMPL TAPERED SP 4.8MM 8MM OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

INFINION 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 28, 2023

M-1 COT - BASE HIGH LOAD 28

FDA Adverse Event
Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 29, 2013

DIALOG PLUS

FDA Adverse Event
Other ·B. BRAUN MEDICAL INC.·Product code KDI·April 28, 2011

7700

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 23, 2008

PLATE,FIXATION,BONE

FDA Adverse Event
Malfunction ·SYNTHES USA·Product code HRS·May 9, 2014

IMPL TAPERED SP 3.7MM 10M M OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 27, 2023

IMPL TAPERED SP 4.8MM 8MM OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·March 3, 2023

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

cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015