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

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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