19 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Zimmer Segmental System Proximal Femoral Component
FDA 510(k)
FDA Class 2
·Orthopedic
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304270961·
AVANOS*
FDA UDI
Avanos Medical, Inc.·00193493944736·Quincke Needle
Halyard
FDA UDI
Avanos Medical, Inc.·10680651944730·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515027893·Alm Ret 4x4 prng, blunt, 4"
MobileLink Acetabular Cup System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575306848·Orthopaedic implant impactor - MobileLink Aceta...
MobileLink Acetabular Cup System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575306732·Orthopaedic implant impactor - MobileLink Aceta...
BiMobile Dual Mobility System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575306862·Orthopaedic implant impactor - General instrument
MobileLink Acetabular Cup System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575306718·Orthopaedic implant impactor - MobileLink Aceta...
MobileLink Acetabular Cup System - Instruments
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575306817·Orthopaedic implant impactor - MobileLink Aceta...
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
FDA 510(k)
FDA Class 2
·Dental
21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
FDA 510(k)
FDA Class 2
·Radiology
TROCAR Ø1.6
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWJ·June 21, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·July 28, 2011
BELT CLIP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·October 17, 2014
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·August 13, 2021
DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·July 27, 2022
COONS DILATOR
FDA Adverse Event
Malfunction
·COOK INC·Product code DRE·July 28, 2022
AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015