23 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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SYLFIRM X
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994624987·PLATE 7200185 ATL VISION ELITE 85MM
ATLANTIS® Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000889623·PLATE 7200185 ATL VISION ELITE 85MM
Fungal Serology
FDA UDI
MICROBIOLOGICS INC.·10634853000213·Candida Antiserum, 2mL
VHS VARI-ANGLE HIP SCREW
FDA UDI
Biomet Orthopedics, LLC·00880304279254·
Vilex Jones Fracture Guidewire
FDA UDI
VILEX LLC·00841731123558·Wire, Guide 1.8x200mm Sgl Trocar
Vilex Jones Fracture Guidewire
FDA UDI
VILEX LLC·00841731123084·Wire, Guide 1.8x200mm Sgl Trocar
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114117·SIMCOE CORTEX EXTR 23GA 0.4MM TXT PK/10
DESS dental smart solutions
FDA UDI
TERRATS MEDICAL SL.·08435457200413·Conical BL
Initia Total Hip System
FDA UDI
KYOCERA CORPORATION·04547898307409·STDHO LINER 40-56/58
Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 1, 2016
MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·October 17, 2003
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 28, 2025
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
FDA Adverse Event
Injury
·ALCON - COUVREUR N.V./ALCON - BELGIUM·Product code LZP·November 17, 2022
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 10, 2011
SPIDERFX EMBOLIC PROTECTION DEVICE
FDA Adverse Event
Other
·EV3 INC.·Product code NTE·September 26, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 1, 2013
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·May 9, 2023