33 results · 23ms · Sources: EU EUDAMED, US FDA

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Clear-Jet Injection Catheter

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

FDA 510(k)
FDA Class 2 ·General Hospital

SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE

FDA 510(k)
FDA Class 2 ·Anesthesiology

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 8, 2015

TENDRIL ST

FDA Adverse Event
Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·July 27, 2011

PARAGON ADMINISTRATION SET

FDA Adverse Event
Malfunction ·I-FLOW, LLC·Product code FRN·June 14, 2013

ACCOLADE SYSTEM

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·September 30, 2008

BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 40

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2024

VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 58

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 28, 2023

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 5, 2025

BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE M 0

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·June 1, 2023

VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 11, 2022

CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

FDA Enforcement
Class II ·Terminated·Med Tec Inc·September 6, 2017

CUP: MPACT ACETABULAR SHELL 56 MULTI-HOLE

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·July 21, 2020

MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 26, 2023

DOUBLE MOBILITY LINER

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·February 11, 2025

COBAS 8000 E602 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LTJ·January 9, 2015

BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 7, 2023

SMS STEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 12, 2026

CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø58

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 10, 2020