28 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CASPIAN SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Sasmar Vanilla
FDA UDI
Sasmar Pharmaceuticals SPRL·09337213008266·PERSONAL LUBRICANT
Ultra-Pro e™ Variable Angle Needle Guide
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436101964·Sterile needle guide with (14 x 147cm) telescop...
SAVANNAH
FDA UDI
SPINAL ELEMENTS·00840916150051·MISCELLANEOUS CADDY 4.00 X 7.40 X 1.13IN
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964074684·Endo Carry-On Procedure Kit
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964077876·Endo Carry-On Procedure Kit
SYRINGE 60ML E/T
FDA Adverse Event
Malfunction
·Product code FMF·August 24, 2021
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020
MANDREL GUIDEWIRE ASSEMBLY
FDA 510(k)
FDA Class 2
·Cardiovascular
TRANS FX ADJUSTABLE PIN TO BAR CLAMP
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 5, 2018
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 9, 2013
SOFTCLIX ® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·May 24, 2011
CARPENTIER-EDWARDS PORCINE AORTIC BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·August 4, 2008
SUBCUTANEOUS, UNIPOLAR LEAD
FDA Adverse Event
Malfunction
·MPRI·Product code LWS·May 21, 2025
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 13, 2016
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021