15 results · 20ms · Sources: EU EUDAMED, US FDA

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CD HORIZON Spinal System

FDA 510(k)
FDA Class 2 ·Orthopedic

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·December 13, 2023

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·December 15, 2023

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·December 14, 2023

OrthoMedFlex

FDA UDI
ORTHOMEDFLEX LLC·M7161121522480·Bridgeback Acetabular Reamer, Size 48mm

Acetabular Reamers

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039028·

DORSAL NAIL PLATE, ANATOMICAL

FDA 510(k)
FDA Class 2 ·Orthopedic

EXCELLA II SPINAL SYSTEM MODEL EC2-00

FDA 510(k)
FDA Class 2 ·Orthopedic

STEM: AMISTEM H HA COATED STD STEM SIZE 3

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 28, 2023

PELVICOL ACELLULAR COLLAGEN MATRIX

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TISSUE·Product code FTL·March 5, 2013

EON RECHARGEABLE IPG

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 22, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

Precise Treatment Table. To be used as part of radiation therapy treatment process.

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·April 17, 2013

All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·March 12, 2014

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023