21 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040095256·Maxima Hedstrom Files 31mm
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810134751·FILES HEDSTROM 15-40 31MM
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033505236·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033505243·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033505229·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033505205·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033505250·
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361012658·PedFuse Remind LES, Quad, 7.0mm x 75mm
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033505212·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm
D/C CORE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
CAAS II QVA
FDA 510(k)
FDA Class 2
·Radiology
AVISTA MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 4, 2019
PRECISION MONTAGE MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 24, 2023
SMALL HOHMANN RETRACTOR 8MM SHORT NARROW TIP 160MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GAD·March 20, 2013
SYNCHRON® LX20 PRO ANALYZER (W/O CAP PIERCER)
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·March 10, 2011
MARQUIS VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·March 10, 2008
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012