27 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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AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814701·GENUMEDI SILVER SIZE VII
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814589·GENUMEDI SAND SIZE VII
Zavation
FDA UDI
Zavation LLC·00842166196520·Whitney TLIF 25, 6deg 7mm
GUTTA PERCHA POINTS
FDA UDI
DiaDent Group International·08806383502467·Gutta Percha Points is used to root canal filin...
NIAGARA® Lateral Access System
FDA UDI
VB Spine LLC·10888857518025·Anterior Blade (Wide Short)
TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
FDA 510(k)
FDA Class 2
·Cardiovascular
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX)
FDA 510(k)
FDA Class 2
·Orthopedic
GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 29, 2022
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·May 1, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 2, 2012
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code OLO·April 25, 2014
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code NPJ·April 25, 2014
PROLENE POLYPROPYLENE MESH
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·May 9, 2013
ACETABULAR REAMER SHAFT
FDA Adverse Event
Malfunction
·GREATBATCH SA·Product code EJB·August 27, 2014
SYSTEM 6 SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 19, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·May 25, 2016
Plum LifeCare 5000 (Plum 1.6) with Dataport, list #s 02507-04-11, 02507-04-51; AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
FDA Recall
Terminated
·Hospira Inc·Product code FRN·August 11, 2009
ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 14, 2017
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·June 14, 2017