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

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MULTIMICRO SURGICAL CAUTERY

FDA 510(k)
FDA Class 2 ·Ophthalmic

Greenwald Surgical Company, Inc.

FDA UDI
GRACE MANUFACTURING, INC.·10801334012298·McCrea Female Sound, Curved. 3/4-inch nominal b...

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100120·Counter Torque, Offset

ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10

FDA 510(k)
FDA Class 1 ·Microbiology

LC PROVIFILL

FDA 510(k)
FDA Class 2 ·Dental

ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM

FDA Adverse Event
Malfunction ·ZYNO MEDICAL, LLC·Product code FPA·December 9, 2020

NATURALYTE

FDA Adverse Event
Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014

HARMONIC ACE 36 CM

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·November 12, 2007

LAP-BAND ACCESS PORT KIT (UNK SIZE)

FDA Adverse Event
Injury ·ALLERGAN·Product code LTI·October 23, 2012

ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·April 8, 2021

BD¿ IV SET BN311 W/O PUMP T-TYPE

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FOZ·December 27, 2019

Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

FDA Enforcement
Class II ·Terminated·Synthes (USA) Products LLC·July 13, 2016

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024