33 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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