19 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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E.S. PENCIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MESI mTablet ECG Diagnostic System, MESI mTablet ECG
FDA 510(k)
FDA Class 2
·Cardiovascular
SINGLE USE ORAL MASK, MODEL HC455A
FDA 510(k)
FDA Class 2
·Anesthesiology
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 1, 2014
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 9, 2012
LOCATOR OVERDENTURE IMPLANT SYSTEM (LODI)
FDA Adverse Event
Injury
·ZEST ANCHORS, INC.·Product code DZE·June 4, 2015
OSS-K DIAPHYSEAL SEGMENT 4CM W/SCREWS
FDA Adverse Event
Injury
·.·Product code JDI·May 5, 2017
OSS POROUS COATED BOWED IM STEM W/SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS AXLE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS POROUS COATED BOWED IM STEM W/SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS FEMORAL BUSHINGS
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS 16MM TIBIAL BEARING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS TIBIAL BUSHING
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS-K 67 MM MODULAR POROUS COATED W/PLUG TIBIAL BASE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS POROUS COATED IM STEM W/SCREW - 11.5 MM X 90 MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS SEGMENTAL FEMORAL - LEFT 7 CM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
OSS TM YOKE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·May 5, 2017
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 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026