11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717108788·Midway Select Probe CP11 Single End Color Coded...
MEDIPLAST AB
FDA registration
MEDIPLAST AB·4 products·🇸🇪 Sweden
MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
FDA 510(k)
FDA Class 2
·Cardiovascular
PINN SECTOR W/ GRIPTION 54MM
FDA Adverse Event
Injury
·DEPUY·Product code LPH·March 18, 2013
APEX MONORAIL
FDA Adverse Event
BOSTON SCIENTIFIC·Product code LOX·March 1, 2011
PUMP MMT-715NAP PRDGM INS V2.1 PL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·March 27, 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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022