11 results
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19ms
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Sources: EU EUDAMED, US FDA
3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802
FDA 510(k)
FDA Class 2
·Radiology
DELTAVEN
FDA UDI
DELTA MED SPA·08032248385252·Safety I.V Catheter in PUR with closed system ,...
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124467·Modular Offset Stem 15mm x 75mm x 2mm
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209109715·KIT, WALK - BLK - CUSTOM
AXIOS Stent and Delivery System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANSPACH KNOTLESS ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
FDA Enforcement
Class II
·Ongoing·Delta Med SpA·August 25, 2021
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·November 30, 2012
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Injury
·TANDEM DIABETES CARE INC.·Product code LZG·June 17, 2015
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
FDA Recall
Open, Classified
·Delta Med SpA Via Guido Rossa 20 Viadana Italy·Product code FOZ·June 21, 2021