18 results · 24ms · Sources: EU EUDAMED, US FDA

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Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS

FDA 510(k)
FDA Class 2 ·Neurology

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 23, 2023

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 5, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 6, 2026

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·August 25, 2011

NEXGEN LPS-FLEX FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER·Product code NJL·October 29, 2014

ENDEAVOR SPRINT RX

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code NIQ·July 12, 2013

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 21, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·January 7, 2025

CONTOUR® PLUS ELITE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 3, 2025

MENTOR SMOOTH ROUND MODERATE PROFILE

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FWM·May 14, 2018

CONTOUR® PLUS ELITE

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·May 15, 2025

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·February 20, 2025

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 23, 2023

bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

FDA Enforcement
Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018