21 results · 22ms · Sources: EU EUDAMED, 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