196 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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INTERLOK BIO-MODULAR HUMERAL STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
Pure Grip
FDA UDI
HENRY SCHEIN, INC.·H65810325071·Pure Grip Small
Pure Grip
FDA UDI
HENRY SCHEIN, INC.·00304040005040·Pure Grip Small
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032507·Baltic Denture System BDLoad ↓ Lm6 PLSEum4DFl C...
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
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 1, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·March 29, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC.·Product code KWP·April 18, 2008
BD PHOENIX¿ NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 19, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 28, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 14, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·May 5, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code LON·May 27, 2026
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 20, 2026
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
BD PANEL PHOENIX NMIC-311
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·August 18, 2024