13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF
FDA 510(k)
FDA Class 2
·Dental
ArgenPMMA Multi98x25-C4
FDA UDI
ARGEN CORPORATION, THE·D818123278·Crown And Bridge, Temporary, Resin
CRYO.S
FDA UDI
Greiner Bio - One GmbH·14039943000191·
WIRELESS IMAGE TRANSMITTER UNIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SCREW, UNKNOWN TYPE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019
SCREW, UNKNOWN TYPE
FDA Adverse Event
Malfunction
·ZIMMER BIOMET SPINE INC.·Product code KWP·June 17, 2019
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code ITJ·May 21, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 26, 2014
TACTILE GUIDANCE SYSTEM V. 2.0
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code HAW·June 3, 2011
HEMOCONCENTRATOR BC 20 PLUS
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code KDI·April 1, 2016
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
Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026