31 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SIGNA 7.0T
FDA 510(k)
FDA Class 2
·Radiology
Luna
FDA UDI
ULTRADENT PRODUCTS, INC.·00883205003003·Luna Opal MB Mini .018 LR4 (-12°T +2°A)
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551111436·HALO, 1203-5 VEST SMALL, ACRYLIC LINER, 1211-1 ...
Olecranon Plate
FDA UDI
I.T.S. GmbH·09120034303005·Olecranon Plate, 8 Hole
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C41432111180·Titanium TLIF Spacer, 32 x 11 x 11mm, 8 deg
OneLIF™
FDA UDI
Novapproach Spine LLC·G07001312111180·Retention Plate, Oblique-Only, Small, 11 mm - 1...
Savant Lumbar Interbody Fusion System
FDA UDI
CURITEVA, INC.·B648C40432111180·PEEK TLIF Spacer, 32 x 11 x 11mm, 8 deg
CORTAC®
FDA UDI
PMT CORPORATION·00650551063292·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 18 CO...
BD® BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·June 20, 2022
NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 8, 2002
CORTAC®
FDA UDI
PMT CORPORATION·00650551087861·SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 18 CO...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 5, 2025
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·October 23, 2008
SPRINTER LEGEND RX BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code LOX·August 5, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
BD¿ BLUNT FILL NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 15, 2022
Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm, P/N 7211118, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code HWC·August 21, 2007
Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026