11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MEDIP PRO
FDA 510(k)
FDA Class 2
·Radiology
GLO MOUTHGUARD BLACK (DZ) *
FDA UDI
Great Lakes Dental Technologies, Ltd.·D7751910261·GLO MOUTHGUARD BLACK (DZ) *
POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO
FDA 510(k)
FDA Class 2
·General Hospital
TDS ABUTMENT FOR NOBEL BIOCARE REPLACE
FDA 510(k)
FDA Class 2
·Dental
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 19, 2020
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·October 9, 2008
SYNCHROMED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 19, 2011
M2A MAGNUM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 26, 2013
CD HORIZON ASTUTE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code NQP·April 16, 2021
BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·April 22, 2020
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025