22 results · 24ms · Sources: EU EUDAMED, 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