18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REGENEROSS ALLOGRAFT PLUS MINERLIZED
FDA 510(k)
FDA Class 2
·Dental
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605541·SPACER 2113645 OLIF25 20MM 18 DEG 18X45
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304470750·
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868267895·
Bernafon
FDA UDI
Bernafon AG·05711584058329·SPEAKER UNIT, 1 L MEDIUM
ARGISTAR YELLOW LF
FDA UDI
ARGEN CORPORATION, THE·D818113645·Gold based noble metal
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136021416·7450 V2 MED W/HG & 2730 NRB
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295007043·GLOBAL ANCHOR PEG GLENOID SIZE 56mmXL CEMENTED
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN DEPUY LOCKING SCREWS
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HWC·May 6, 2011
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·May 15, 2013
TRIOLOGY 100`
FDA Adverse Event
Malfunction
·RESPIRONICS INC.,·Product code CBK·September 17, 2014
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·August 17, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·April 8, 2025
TI-SU03 GC
FDA Adverse Event
Injury
·NAKANISHI INC. (NSK)·Product code EFB·May 26, 2015
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