18 results · 32ms · Sources: EU EUDAMED, US FDA

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EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES

FDA 510(k)
FDA Class 2 ·Ophthalmic

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704508864·

APEX Revision Knee

FDA UDI
Omni Life Science, Inc.·00841690124603·Modular Offset Stem 17mm x 125mm 4mm

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

TECO ISE REAGENT SET FOR CX SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ELECTRODE, PACEMAKER, PERMANENT

FDA Adverse Event
Injury ·RICE CREEK MFG·Product code DTB·June 7, 2013

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

HARMONIC SCALPEL GENERATOR

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·September 10, 2008

COCR BALL HEAD 12/14 Ø 32 SIZE L +3.5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·July 25, 2017

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·April 25, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·January 4, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Injury ·COOK INC·Product code FGE·February 18, 2019

ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·July 26, 2019

NEEDLE 25X1-1/2 RB

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 5, 2019

IBALANCE UKA TIBIAL BEARING, SIZE 4, 8MM

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code JWH·February 24, 2016

Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 9, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022