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