12 results · 20ms · Sources: EU EUDAMED, US FDA

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VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

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

Wrist Lacer

FDA UDI
MEDICAL SPECIALTIES INCORPORATED·00802357239269·

1ML 31GX6MM U-100 INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·April 21, 2021

METASURG NITINOL STAPLE IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

Spectra Wearable

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

RELION INSULIN SYRINGE

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMI·December 21, 2020

TENDRIL SDX

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

NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER INC·Product code JWH·August 18, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·July 12, 2013

RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver

FDA Enforcement
Class II ·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·April 20, 2016

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