10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ZEE SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526799417·MANUMED ACTIVE WRIST LEFT SAND L
ERA® Implant Abutment Micro Angled Base, 6mm Cuff (C)
FDA UDI
STERNGOLD DENTAL LLC·00841549104862·Implant retained overdentures are an establishe...
COLLAGEN NERVE CUFF
FDA 510(k)
FDA Class 2
·Neurology
CUFFINK
FDA 510(k)
FDA Class 2
·Orthopedic
REALSEAL
FDA Adverse Event
Injury
·SYBRONENDO·Product code KIF·May 15, 2014
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
1.5X11MM HT X-DR SCREW
FDA Adverse Event
BIOMET MICROFIXATION·Product code HWC·August 24, 2010
SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567502281, 453567502282, 453567502283, 453567502284, 453567502285, 453567502286, 459801585212.
FDA Enforcement
Class I
·Ongoing·Philips North America Llc·July 3, 2024
Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·April 9, 2014