14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Bone Screws
FDA UDI
ORTHOFIX SRL·18033509850301·CORTICAL SCREW 160/50 MM STERILE SHAFT D 6 MM ...
R82
FDA UDI
R82 A/S·05707292787323·
SunTech
FDA UDI
SUNTECH MEDICAL, INC.·10840935109624·
NBP-ONE
FDA UDI
SUNTECH MEDICAL, INC.·10840935109198·
BPL
FDA UDI
SUNTECH MEDICAL, INC.·10840935109150·
Grasping forceps
FDA UDI
SOPRO-COMEG GmbH·04059082022086·
Bionet
FDA UDI
SUNTECH MEDICAL, INC.·10840935109266·
HET BIPOLAR ELECTROCAUTERY FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LARS AC Band Device
FDA 510(k)
FDA Class 2
·Orthopedic
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·November 30, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 2, 2014
IN TOUCH EU
FDA Adverse Event
Malfunction
·FLEXTRONICS EMS CANADA·Product code FNL·December 19, 2012
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