12 results · 19ms · Sources: EU EUDAMED, US FDA

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NuVasive Reline System

FDA 510(k)
FDA Class 2 ·Orthopedic

ASO Ankle Stabilizer

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357231812·

CARESCAPE B650, E-musb

FDA 510(k)
FDA Class 2 ·Cardiovascular

Nerivio, FGD000075-4.7

FDA 510(k)
FDA Class 2 ·Neurology

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 4, 2014

SECURE II MED/SURG BED

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

COULTER® LH 750 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·July 12, 2013

DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic.

FDA Recall
Terminated ·BD Diagnostic Systems Lee Laboratories·Product code GTQ·August 8, 2007

dS Breast 7ch 3.0T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 4, 2024

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

Model Number L111, ESSENTIO DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025