17 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TRIMED CLAVICLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902163906·SLEEVE 9112509 SWITCHING SLEEVE 20MM
Biosens cartridges Clear
FDA UDI
PERFLEX LTD·07290110501594·box of 6 identical cartridges sealed in aluminu...
2530 BALLOON CONTROLLER
FDA UDI
HANS RUDOLPH, INC.·00874750008940·2530 INFL-3 BALLOON CNTRL 115V
T-Crystal cartridges Clear
FDA UDI
PERFLEX LTD·07290110500191·Box of 6 identical cartridges sealed in aluminu...
Disc Prep
FDA UDI
Life Spine, Inc.·00190837089962·
T-Crystal cartridges Clear
FDA UDI
PERFLEX LTD·07290110506094·5 identical cartridges sealed in a vacuum bag ;...
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
FDA 510(k)
FDA Class 2
·Neurology
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code OLO·April 25, 2014
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code NPJ·April 25, 2014
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·May 14, 2013
CLARION
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·May 25, 2011
SIMPLEX P TWIN PACK
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code LOD·August 7, 2008
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025