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

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ORTHOFIX SCREW

FDA 510(k)
FDA Class 2 ·Dental

PIVOX™ Oblique Lateral Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605558·SPACER 2113650 OLIF25 20MM 18 DEG 18X50

COMPREHENSIVE SHOULDER SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304456075·

Comprehensive® Shoulder System

FDA UDI
Biomet Orthopedics, LLC·00887868267949·

7400 RV2 MASK

FDA UDI
HANS RUDOLPH, INC.·00817136021461·7400 MEDIUM W/HG & 2730 NRB

Neo-SL

FDA UDI
Life Spine, Inc.·00190837036812·NEO SL 1-3 Level ACP Block

ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD

FDA 510(k)
FDA Class 2 ·Dental

NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM

FDA 510(k)
FDA Class 1 ·General Hospital

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FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWS·January 2, 2020

TINBN VANGUARD INT PS ANAT FM R 65MM

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code JWH·March 7, 2025

ALIGN S URETHRAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·BARD SHANNON LIMITED·Product code FTL·May 10, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 3, 2011

UNKNOWN LUMBAR IMPLANT

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·April 11, 2022

ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

FDA Adverse Event
Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

EMBLEM S-ICD Model A209

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025