23 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTELLIVUE PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COMPREHENSIVE SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304470743·
Comprehensive® Shoulder System
FDA UDI
Biomet Orthopedics, LLC·00887868268014·
2100 3 WAY STOPCOCK
FDA UDI
HANS RUDOLPH, INC.·00817136021515·2100C 3WAY STPCK 35OD, 3.2mmHB
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642105056·PS3 Screw 6.5mm x 55mm
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
SAPPHIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
11/13 S-ROM 40MM M SPEC+0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 15, 2013
TRILOGY 02
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 17, 2014
ADVANTAGE SERIES 29
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 24, 2011
E1 44-41 STD HMRL BRNG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 21, 2020
COMP RVS TRAY +10MM CO 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·April 21, 2020
COMP RVS HMRL TI TRAY 44MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·April 17, 2017
COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING 44MM STANDARD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code PAO·June 30, 2017
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
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 2026
MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NKM·July 7, 2017
BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Company·July 27, 2022