19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
FDA 510(k)
FDA Class 2
·Dental
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074025070·BONE SCREW 7022890 20 DEG ILC 8.5X90 SS
VALENTINE INTL. LTD.
FDA registration
VALENTINE INTL. LTD.·101 products·🇹🇼 Taiwan
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
INTRALASE 600C LASER KERATOME
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 23, 2019
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 13, 2019
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·May 11, 2018
TRIAGE PROFILER SOB PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019
TRIAGE PROFILER SOB PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019
TRIAGE D-DIMER TEST
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code GHH·October 2, 2019
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code GHH·September 17, 2019
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR INC.·Product code GHH·May 7, 2019
TRIAGE D-DIMER PANEL
FDA Adverse Event
Malfunction
·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·August 17, 2018
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·March 27, 2013
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·July 11, 2014
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·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