13 results
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NERVUS MONITOR
FDA 510(k)
FDA Class 2
·Neurology
Aztec
FDA UDI
Aztecmed/Ent LLC·B87110211850·McGee Anterior Pick 1mm long point
SPROTTE® Sono
FDA UDI
Pajunk GmbH Medizintechnologie·14048223027643·SPROTTE® Sono 25G x 3 1/2" (90mm), sterile, w...
SPROTTE®
FDA UDI
Pajunk GmbH Medizintechnologie·04048223114841·021185-29A
SPROTTE®
FDA UDI
Pajunk GmbH Medizintechnologie·04048223052792·021185-29A
ACCU-CHEK AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·March 25, 2021
PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROPUNCTURE INTRODUCER SET
FDA Adverse Event
Malfunction
·COOK MEDICAL INCORPORATED·Product code DYB·March 21, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 16, 2011
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·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