23 results · 30ms · Sources: EU EUDAMED, 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