10 results
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19ms
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Sources: EU EUDAMED, US FDA
URINE COLLECTION BAG TYPE AP2090V
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Leica Biosystems
FDA UDI
Leica Biosystems Richmond, Inc.·20849832026765·Microbiopsy Cassettes, Blue
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 21, 2014
AIR SHIELDS
FDA Adverse Event
Malfunction
·HILL-ROM·Product code FMZ·September 20, 2012
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 17, 2010
SHAFT FOR TREPHINE ATTACHMENTS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWK·August 23, 2013
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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