10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
F&P Solo Mask Range
FDA 510(k)
FDA Class 2
·Anesthesiology
RBknee
FDA 510(k)
FDA Class 2
·Radiology
MEDUSA VASCULAR PLUG
FDA 510(k)
FDA Class 2
·Cardiovascular
2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HWC·May 19, 2017
RIATA ST OPTIM ACTIVE 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
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 12, 2013
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 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
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026