13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SUPER EON PLUS FEMORAL STEMS
FDA 510(k)
FDA Class 2
·Orthopedic
RD® QUICK LOAD®
FDA UDI
LSI Solutions, Inc.·00850200006315·RD® QUICK LOAD® SURGICAL SUTURE, 2-0 POLYPROPYL...
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120209891·Carbide, cylinder flat, excavating and fissure bur
ENGLE DENTAL SYSTEMS, LLC
FDA registration
ENGLE DENTAL SYSTEMS, LLC·3 products·🇺🇸 United States
SPERM WASH MEDIUM, CAT# 2003/2005
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PROCLUDE
FDA 510(k)
FDA Class 1
·Dental
PARAPAC 'MEDIC' (K020899)
FDA Adverse Event
Death
·SMITHS MEDICAL INTERNATIONAL·Product code BTL·August 6, 2004
BIOMEDICS 1 DAY (52%) STRIP (OCUFILCON B)
FDA Adverse Event
Injury
·COOPERVISION CARRIBEAN CORPORATION·Product code MVN·August 29, 2019
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·March 20, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 16, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC INC·Product code KWP·March 28, 2008
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