28 results · 22ms · Sources: EU EUDAMED, US FDA

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Pain Therapy Device(Model: P.T.S-X)

FDA 510(k)
FDA Class 2 ·Physical Medicine

Zavation

FDA UDI
Zavation LLC·00197157002794·CIF 14x18, 7 deg, -11

IWL2020 Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INFINITY CENTRALSTATION WITH INFINITY M300

FDA 510(k)
FDA Class 2 ·Cardiovascular

CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·January 29, 2021

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 23, 2026

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

XIA DEFORMITY UNI-PLANAR SCREW 5.5 X 45MM

FDA Adverse Event
Injury ·STRYKER SPINE BORDEAUX·Product code NKB·August 17, 2011

TOTAL ASR ACET IMP SIZE 62

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.8010379·Product code KWA·July 16, 2013

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 13, 2024

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 13, 2025

MPACT ACETABULAR SYSTEM IMPLANTS

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LPH·November 5, 2025

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 18, 2025

FOLYSIL TIEMANN CATH 5/15ML

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code EZL·October 24, 2018

FOLYSIL TIEMANN CATH 5/15ML

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code EZL·October 24, 2018

FOLYSIL TIEMANN CATH 5/15ML

FDA Adverse Event
Injury ·COLOPLAST A/S·Product code EZL·October 24, 2018

MECTACER BIOLOX DELTA FEMORAL BALL HEAD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·August 27, 2025

AMISTEM-P COLLARED

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 14, 2025

MPACT ACETABULAR SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 6, 2026

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

FDA Enforcement
Class II ·Ongoing·Philips Medical Systems Nederland B.V.·May 14, 2025