30 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SEXTANT SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009
AirLife™
FDA UDI
AIRLIFE·10889483569559·AirLife™ Adult Dual Dial Venturi Style Mask Wit...
AirLife™
FDA UDI
VYAIRE MEDICAL, INC.·10190752116504·AirLife™ Adult Dual Dial Venturi Style Mask Wit...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001255·artVeneer life lower anteriors, UBL, B3
OptiLIF Endo, Direct Visualization System
FDA UDI
SPINEOLOGY INC.·M7401001255·TF Endo Head
LIFEPAK® 15 monitor/defibrillator
FDA UDI
PHYSIO-CONTROL, INC.·00883873911648·15AABBABBABBBAAAAAAAAAABLP15 MONITOR/DEFIB
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361008446·PedFuse Respond, CNL, 6.0mm x 55mm
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494462849·Cannulated Tibial Reamer
D 10.5mm, WL 180mm
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL 4300 PSARRAY EEG ELECTRODE SET
FDA 510(k)
FDA Class 2
·Neurology
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962156308·HIP ARTHROSCOPE SHEATH, W/2 STOPCOCK, 5.5MM, BL...
0009613348-2026-001255
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·January 23, 2026
CARE-FUSION
FDA Adverse Event
Other
·CAREFUSION RESPIRATORY CARE·Product code BYF·June 24, 2010
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 14, 2018
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·February 24, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 22, 2008
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
FDA Recall
Open, Classified
·Physio-Control, Inc.·Product code MKJ·September 29, 2023
LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
FDA Enforcement
Class II
·Ongoing·Physio-Control, Inc.·November 22, 2023