12 results
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35ms
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Sources: EU EUDAMED, US FDA
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
multiSTATION™
FDA UDI
LSI Solutions, Inc.·00850012846406·Cannula Adapter
miniARM® multiSTATION™ System
FDA UDI
LSI Solutions, Inc.·00850200006599·miniARM® CANNULA ADAPTOR KIT
ISODAN
FDA 510(k)
FDA Class 2
·Dental
OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SATELLITE SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code NVR·May 5, 2011
5MM, 33CM PEEK MONOPOLAR HANDLE 33CM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·April 26, 2013
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·April 22, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·July 24, 2008
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
FDA Enforcement
Class II
·Terminated·Care Essentials Pty., Ltd.·February 12, 2020
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021