14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK ULTRFLEX INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
HT III SA FIXTURE SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BONE SCREW Ø6,5 H.35MM
FDA Adverse Event
Malfunction
·LIMACORPORATE SPA·Product code LPH·June 16, 2021
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
LNCS DC-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·March 11, 2017
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2013
INTERNAL, TRAJECTORY GUIDE KIT (NAVIGUS)
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 11, 2011
EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code MAF·August 7, 2008
BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 16, 2019
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025