20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTAS SYSTEM FROM RESTORATION ROBOTICS
FDA 510(k)
FDA Class 2
·Neurology
IVAS BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Orthopedic
VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
FDA 510(k)
FDA Class 2
·Cardiovascular
EASYSPINE SCREW, UNKOWN SIZE OR TYPE
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·August 17, 2020
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·July 31, 2017
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·June 10, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·May 21, 2013
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 26, 2014
BD VACUTAINER® SERUM BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 19, 2022
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE ROD, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE SCREW, UNKNOWN
FDA Adverse Event
Injury
·LDR MEDICAL·Product code NKB·March 24, 2020
EASY SPINE ROD, UNKNOWN
FDA Adverse Event
Malfunction
·LDR MEDICAL·Product code NKB·March 24, 2020
EASYSPINE SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code NKB·July 9, 2019
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·September 15, 2015
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·May 12, 2017
BREAS VIVO 60
FDA Adverse Event
Malfunction
·BREAS MEDICAL AB·Product code NOU·May 12, 2017
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025