18 results · 20ms · Sources: EU EUDAMED, US FDA

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XIA SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033520567·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033520536·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033520529·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033520550·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033520543·

EZ2C

FDA UDI
FGX INTERNATIONAL INC.·00193033520574·

SCS DT-02 TRANSVERSE CONNECTOR

FDA 510(k)
FDA Class 2 ·Orthopedic

SPAZZ

FDA 510(k)
FDA Class 1 ·Physical Medicine

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 13, 2014

AXIOM ARISTOS VX PLUS

FDA Adverse Event
Injury ·SIEMENS SHANGHAI MEDICAL EQUIPMENT LTD·Product code MQB·April 7, 2021

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 20, 2013

CLEAR, PVC CONTRAST INJECTION LINE

FDA Adverse Event
Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXJ·February 4, 2011

INFINITI VISION SYSTEM

FDA Adverse Event
Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 14, 2008

IMPELLA CP

FDA Adverse Event
Death ·ABIOMED, INC.·Product code OZD·April 4, 2025

Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901

FDA Enforcement
Class II ·Ongoing·Smith & Nephew, Inc.·April 29, 2020

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022