17 results · 21ms · Sources: EU EUDAMED, US FDA

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AIROS 8P Sequential Compression Device

FDA 510(k)
FDA Class 2 ·Cardiovascular

IPM WOUND GEL BIO

FDA 510(k)
FDA Unclassified ·Unknown

CANDELA GENTLE YAG LASER SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

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

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

ROTATING MULTIPLE CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 4, 2014

PRIME ZOOM STRETCHER, 30" LITTER

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code INK·August 16, 2011

COULTER AC*T DIFF HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·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

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

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

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