15 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GC Ortho Connect, GC Ortho Etching Gel
FDA 510(k)
FDA Class 2
·Dental
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120502·Guidewire 1.2x150mm Dbl Trocar
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120519·Guidewire 1.2x150mm Sgl Trocar
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828106993·GEN4 Direct Access
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100066·TEMPORAL SPECULUM CLOSED WIRE
VITALWARE VMS
FDA 510(k)
FDA Class 2
·Cardiovascular
TRINITY ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 11, 2024
MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·August 16, 2016
3006179046-2018-00103
FDA Adverse Event
Injury
·November 1, 2018
NX3 LIGHT CURE CEMENT
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
SETROX S 53
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code DTB·August 29, 2008
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·August 12, 2016
Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026