196 results · 22ms · Sources: EU EUDAMED, 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