13 results
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36ms
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Sources: EU EUDAMED, US FDA
ONETOUCH REVEAL
FDA 510(k)
FDA Class 2
·General Hospital
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837044268·18mm Aileron Core Assembly
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837044275·Aileron Implant Core, Large
Aileron Posterior Fusion System
FDA UDI
Life Spine, Inc.·00190837044282·Aileron Implant Plate, Large
VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED
FDA 510(k)
FDA Class 2
·Anesthesiology
3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
CORTSCR Ø3.5 L36 SST
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·May 29, 2013
ARCTIC SUN
FDA Adverse Event
Injury
·MEDIVANCE·Product code DWJ·June 12, 2011
INFINITI VISION SYSTEM
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CTR.·Product code HQC·August 22, 2008
The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures
FDA Enforcement
Class II
·Terminated·Acumed LLC·May 7, 2014
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·February 28, 2018
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Enforcement
Class II
·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021