10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PYXIS 3D Titanium Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
SET, ADMINISTRATION, INTRAVASCULAR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016
OSUNG MND
FDA UDI
OSUNG MND Co., Ltd.·08800075615596·A rotary cutting device made of high-grade stee...
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1
FDA 510(k)
FDA Class 2
·Neurology
INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET
FDA 510(k)
FDA Class 2
·General Hospital
IDENTITY SR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2008
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 18, 2011
GROSHONG CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) S
FDA Adverse Event
Injury
·C. R. BARD INC. (BASD)·Product code LJS·July 10, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026