13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Kyphoplasty Balloon Catheter
FDA 510(k)
FDA Class 2
·Orthopedic
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046510803·Rotary FG gold diamond instrument for dental ap...
BriefCase
FDA 510(k)
FDA Class 2
·Radiology
SIGNA PET/MR
FDA 510(k)
FDA Class 2
·Radiology
TRIDENT 0 DEG X3 INSERT 32MM HEAD
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·May 1, 2019
NEXTAR SPINE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024
CURRENT RF DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
RESOLUTE INTEGRITY OTW
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·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
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 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