10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDI-CULT SPERM PREPARATION - MEDIUM;
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Capstone Control PTC Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169679689·SPACER 4991332 CONTROL PTC 0 DEG 13X32
CAPSTONE® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994387189·SPACER 2991332 CAPSTONE PEEK 13X32
CAPSTONE CONTROL™ Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169055605·SPACER 3991332 CAPSTONE IR 0 DEG 13X32
AIA-PACK RBC FOLATE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XACT Robotic System
FDA 510(k)
FDA Class 2
·Radiology
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 6, 2013
CAPSURE SP NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·February 15, 2011
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·August 8, 2014
Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.
FDA Enforcement
Class II
·Terminated·Integra Limited·May 22, 2019