15 results
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25ms
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Sources: EU EUDAMED, US FDA
AT WORK DRUG TEST, MODEL 9147T AWT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890108361·Zirlux Scanning Abut Straumman
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964152368·Endo Carry-on Procedure Kit contains Intercept ...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450096901·
OPTIQUE
FDA UDI
FGX INTERNATIONAL INC.·00031568560903·
OPTIQUE
FDA UDI
FGX INTERNATIONAL INC.·00024021560909·
BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
FDA 510(k)
FDA Class 1
·General Hospital
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·March 19, 2013
PENTA SURGICAL LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·March 3, 2011
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008
REVITAN, RASP, DISTAL, CURVED, 14/140
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 11, 2018
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
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019