31 results · 23ms · Sources: EU EUDAMED, 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