20 results · 23ms · Sources: EU EUDAMED, US FDA

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TOMOTHERAPY TREATMENT SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Kerrison

FDA UDI
ELLIQUENCE, LLC·00846338005306·

DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000

FDA 510(k)
FDA Class 2 ·Orthopedic

MODIFICATION TO MEDSTATION

FDA 510(k)
FDA Class 2 ·Radiology

VAPR WEDGE ELECTRODE

FDA Adverse Event
Malfunction ·DEPUY MITEK·Product code GEI·March 24, 2006

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Malfunction ·LDR MEDICAL·Product code OVE·February 4, 2020

AVISTA MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 21, 2020

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X17MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code OVE·April 13, 2020

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H5MM 14X15.5MM

FDA Adverse Event
Malfunction ·LDR MEDICAL·Product code OVE·August 6, 2020

35 CM BIPOLAR LEAD

FDA Adverse Event
Injury ·GREATBATCH MEDICAL·Product code DTB·May 15, 2013

ASR ACETABULAR CUPS 52

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 9, 2011

HARMONIC ACE 36CM

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 13, 2008

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

SPIRALOK W/ ORTHOCORD VIOLET/BLUE, 5MM

FDA Adverse Event
Injury ·DEPUY MITEK·Product code MAI·March 16, 2007

SPIRALOK W/ ORTHOCORD VIOLET/BLUE, 5MM

FDA Adverse Event
Injury ·DEPUY MITEK·Product code MAI·March 16, 2007

SPACER, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

ROI-C IMPLANT, UNKNOWN SIZE

FDA Adverse Event
Injury ·LDR MÉDICAL·Product code OVE·September 21, 2021

ROI-C BI-PACK CAGE PRE-FILLED WITH BF+ BONE SUBSTITUTE H6MM 14X15,5MM

FDA Adverse Event
Malfunction ·LDR MÉDICAL·Product code OVE·August 17, 2022

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026