19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271821·
FX V 135 stem
FDA UDI
FX SOLUTIONS·03701037315170·FX V 135 stem TA6V Ø36/10 cementless Ti/HA
ZenFlex CM
FDA UDI
Kerr Corporation·00195062145667·.20/.06/21mm ZenFlex CM NiTi FILE REFILL PACK
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575182312·Shell/Insert Adapter; 20° inclination, + 8 / 1...
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575182329·Shell/Insert Adapter; 20° inclination, + 8 / 1...
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575182282·Shell/Insert Adapter; 20° inclination, + 8 / 1...
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575182299·Shell/Insert Adapter; 20° inclination, + 8 / 1...
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575190294·Shell/Insert Adapter; 20° inclination, + 8 / 1...
MobileLink Acetabular Cup System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575182305·Shell/Insert Adapter; 20° inclination, + 8 / 1...
FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
FDA 510(k)
FDA Class 2
·Dental
CLEARVIEW EXACT II INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 22, 2013
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 8, 2011
INTIMA II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 31, 2018
T2 STRATOSPHERE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020
I-STAT CHEM8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024
MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·October 4, 2023