19 results · 23ms · Sources: EU EUDAMED, US FDA

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DAMON 3 MODIFIED

FDA 510(k)
FDA Class 2 ·Dental

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450140437·

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 3, 2020

MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES

FDA 510(k)
FDA Class 2 ·Cardiovascular

SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET

FDA 510(k)
FDA Class 2 ·General Hospital

RAD-57 PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·July 26, 2023

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code LXH·March 31, 2017

TAXUS® LIBERTÉ® LONG

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 11, 2013

SELOX ST 60

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NVZ·March 15, 2011

SILICONE ADVANCED OPTIC-VIOLET SHIELD

FDA Adverse Event
Malfunction ·BAUSCH & LOMB·Product code HQL·May 22, 2008

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·December 29, 2024

ARCHITECT ANTI-TPO

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 11, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 16, 2025

ARCHITECT ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code JZO·May 23, 2025

ALINITY I ANTI-TPO REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·March 17, 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

Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016