12 results
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26ms
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Sources: EU EUDAMED, US FDA
DIGISTIM II
FDA 510(k)
FDA Class 2
·Anesthesiology
EasyTouch
FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18221371·
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011822137100·Ortho-Cast Buccal tubes M-Series 22, -10° Torqu...
N.A.
FDA UDI
DENTAURUM GmbH & Co.KG·J011822137200·Ortho-Cast Buccal tubes M-Series 22, -10° Torqu...
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
OK Plus Indicator
FDA 510(k)
FDA Class 2
·General Hospital
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·November 7, 2012
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 1, 2010
A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·December 17, 2014
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
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025