12 results
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19ms
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Sources: EU EUDAMED, US FDA
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Hegar Dilator
FDA UDI
MEDGYN PRODUCTS, INC.·M803030839·Hegar Dilator 17-18mm
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
FDA UDI
TENON MEDICAL, INC.·B74240308390·10mm Bone Tamp Head
VASCO TIP BI 9/52 S
FDA Adverse Event
Injury
·VASCO MED·Product code DTB·June 2, 1999
CENTRAL VENOUS CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
CLS VARUS STEM/CLS 135 STEM
FDA 510(k)
FDA Class 2
·Orthopedic
COMPLETE
FDA Adverse Event
Injury
·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·April 17, 2020
TERUMO CENTRIFUGAL SYSTEM
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DWA·March 28, 2013
COOK
FDA Adverse Event
Malfunction
·COOK INCORPORATED·Product code DYB·March 22, 2011
OCUSCAN RXP
FDA Adverse Event
Injury
·ALCON-IRVINE TECHNOLOGY CENTER·Product code IYO·April 17, 2008
Nerve Block Tray Catalog Number: 3764R2
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 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