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

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PreView-III™ Anterior Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

Patellavator Knee Orthosis

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357236275·

ET SMARTFIT ABUTMENT

FDA 510(k)
FDA Class 2 ·Dental

ESSEX ENDOSCOPE, MODEL SXD-1000

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

H-MAX S STEM

FDA Adverse Event
Injury ·Product code KWY·April 17, 2026

RIATA ST PASSIVE FIXATION

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

GYNECARE TVT RETROPUBIC SYSTEM

FDA Adverse Event
Injury ·ETHICON INC.·Product code OTN·July 12, 2013

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

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

FDA Enforcement
Class II ·Ongoing·Abbott Medical·January 1, 2025