13 results · 21ms · Sources: EU EUDAMED, US FDA

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INION HEXALON BIODEGRADABLE ACL/PCL SCREW

FDA 510(k)
FDA Class 2 ·Orthopedic

ULTRAPOWER

FDA UDI
Conmed Corporation·10845854004951·ULTRAPOWER BUR, ACORN (MUSTARD) 5MM

SunMed

FDA UDI
SUNMED, LLC·10889483044018·INTRODUCER PORTED 15FR

TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2

FDA 510(k)
FDA Class 2 ·Orthopedic

COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES

FDA 510(k)
FDA Class 1 ·General Hospital

ULTRA DRIVE 6MM PLUG PULLER

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JDX·July 20, 2022

UNKNOWN EMPRINT GENERATOR

FDA Adverse Event
Injury ·COVIDIEN LP - SUPERDIMENSION INC·Product code NEY·November 22, 2023

OBTRYX SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 26, 2013

SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT)

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code DHR·March 17, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIQ·March 25, 2008

STOCKERT CORONARY PERFUSION CANNULAE

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA SRL·Product code DWF·March 7, 2019

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

The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014