12 results · 19ms · Sources: EU EUDAMED, US FDA

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TISSUE/POLYP TRAP SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

COCR BALL HEAD 12/14 32 SIZE S -3.5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·December 1, 2020

LED LAMP OR OTHER

FDA 510(k)
FDA Class 2 ·Ophthalmic

PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

FDA 510(k)
FDA Class 3 ·Orthopedic

CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 26, 2022

LINER: MPACT FLAT PE HC LINER Ø32/D

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·April 8, 2020

HEARTSTART MRX -EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·November 29, 2012

CORE MICRO DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·November 12, 2010

TX1 TISSUE REMOVAL SYSTEM - MICROTIP

FDA Adverse Event
Malfunction ·TENEX HEALTH·Product code LFL·February 24, 2014

IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code ERL·February 13, 2017

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

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