178 results · 20ms · Sources: EU EUDAMED, US FDA

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SONATA MICRO HYBRID COMPOSITE

FDA 510(k)
FDA Class 2 ·Dental

Channels

FDA UDI
HENRY SCHEIN, INC.·10304040160791·Channels Flex 25mm 30.06

APC™ II Unitek™ Mini Uni-Twin

FDA UDI
3M UNITEK CORPORATION·00652221062437·Mini Uni-Twin(TM) Bracket APC(TM) II LL4 -11T/-...

Midway Select

FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717107221·Gutta Percha Points, Taper .04, Size #80, 60pcs...

APC™ PLUS Unitek™ Mini Uni-Twin

FDA UDI
3M UNITEK CORPORATION·00652221093455·Mini Uni-Twin(TM) Bracket APC(TM) PLUS LL4 -11T...

TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O

FDA 510(k)
FDA Class 1 ·General Hospital

JAX

FDA 510(k)
FDA Class 2 ·Orthopedic

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007

ETRIO

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·March 26, 2013

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·February 10, 2011

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 12, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 2, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 6, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

PANEL PHOENIX PMIC-110

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 30, 2026

Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

FDA Enforcement
Class II ·Terminated·Abbott Point Of Care Inc.·December 11, 2013