22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BARD AQUAGUIDE URETERAL CONDUIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Latitude
FDA UDI
TORNIER, INC.·00840338602244·Ulnar Base
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120304381·Diamond, cylinder flat, medium grit
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438
FDA 510(k)
FDA Class 3
·Cardiovascular
SMART RAD
FDA 510(k)
FDA Class 2
·Radiology
MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
FDA 510(k)
FDA Class 2
·General Hospital
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 14, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019
NAVLOCK UNIVERSAL GREEN TRACKER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 30, 2015
SCREW DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 5, 2019
EPIX UNIVERSAL CLIP APPLIER
FDA Adverse Event
APPLIED MEDICAL·Product code FZP·March 26, 2013
RESTORE PRIME ADVANCED
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 9, 2011
CRITICATH
FDA Adverse Event
Malfunction
·BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.·Product code DYG·April 16, 2008
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 18, 2019
CART 9734056 S7 STAFF SHRT 100-120V INTL
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·May 18, 2018
NAV THORACIC PROBE TIP
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC.·Product code OLO·August 27, 2014
LIFEWISE BLOOD PRESSURE MONITOR
FDA Adverse Event
Injury
·RADIOSHACK·Product code DXN·October 20, 2004
NEUROLOGICAL STEREOTAXIC INSTRUMENT
FDA Adverse Event
Injury
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·October 26, 2015
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 Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016