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