22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LEVO TINNITUS MASKING SOFTWARE DEVICE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017750·K-Wire, Double Ended, Trocar Point, Diameter 0....
SSW CARBIDE TRIMMING AND FINISHING
FDA UDI
Ss White Burs, Inc.·D6901408452·20 BLADE FINISHING CARBIDE 8902 - 5 PACK
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319705124·Babcock Forceps 7-3/4" (19.7cm), 9mm wide jaws
VITEK 2 ESBL TEST
FDA 510(k)
FDA Class 2
·Microbiology
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
MINIMAX STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025
MINIMAX RIGHT ANATOMICAL BROACH SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LXH·February 20, 2020
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2019
LANTUS SOLO STAR ULTRA FINE NEEDLE
FDA Adverse Event
Malfunction
·CANAMCARE·Product code NBW·May 24, 2013
TERUMO CENTRIFUGAL SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·May 5, 2008
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 31, 2011
MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2017
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 4, 2019
CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 4, 2019
CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·December 27, 2019
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2021
VITEK® 2 AST-N350
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 17, 2018
VITEK® 2 AST-N350
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LON·December 17, 2018
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014