16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
HYALEX® MTP Hemiarthroplasty Implant
FDA 510(k)
FDA Class 2
·Orthopedic
Vivid ZirDisc Zircon Zahn System
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724Q2500741·95x16mm 03HT (Translucent)
SpheRx
FDA UDI
Nuvasive, Inc.·00887517450951·SpheRx II Anterior Screwdriver, Fixed
Streck Viral Extraction Kit
FDA UDI
STRECK, INC.·00844509002376·The Streck® Viral Extraction Kit is intended fo...
AMC
FDA UDI
Advantage Medical Electronics, LLC·00849593023474·5 Lead GE Hyperbaric Chamber Cable (Inner)4'
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036159450·
SMITH'S PORTEX NEEDLE-PRO EDGE SAFETY DEVICE WITH
FDA Adverse Event
Malfunction
·SMITH'S MEDICAL ASD, INC·Product code FMF·February 8, 2007
Elevate Moisturizing Spray
FDA 510(k)
FDA Unclassified
·Unknown
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
FDA 510(k)
FDA Class 2
·Cardiovascular
IMP,TSV,4.1MM,SBM,8
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 7, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 8, 2025
COLIBRI
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·November 14, 2014
URETEX SUPPORT PP TRANSOBTUR2 KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·September 9, 2011
QUATTRODE
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·July 23, 2013
IMP,TSV,4.1MM,SBM,8
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 31, 2023
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013