10 results
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26ms
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Sources: EU EUDAMED, US FDA
URINE COLLECTION BAG TYPE 2132V
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SURE-SNAP
FDA UDI
Gc Orthodontics America Inc.·E53580272900001·SURE-SNAP 2. MOLAR UPR LFT SZ 29
SYNTHES PROXIMAL HUMERAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
RIMCLOSE BONE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
REALSEAL
FDA Adverse Event
Injury
·SYBRONENDO·Product code KIF·May 9, 2014
LIGACLIP** ENDOSCOPIC CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 24, 2012
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 17, 2010
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
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015