14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
FDA 510(k)
FDA Class 2
·Radiology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809866247·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...
SOAR Retractor System
FDA UDI
SPINEOLOGY INC.·M7403042605·26mm x 50mm Portal Tube
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981183042·15x13x05mm Rasp, Flat
REPROCESSED ATHROSCOPICS BURS
FDA 510(k)
FDA Class 2
·Orthopedic
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO., (BD)·Product code JKA·August 15, 2019
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 2, 2013
EXPRESS VASCULAR LD PREMOUNTED STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·April 6, 2011
VITALITY DS VR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
NCB, DF PLATE, RIGHT, 13 HOLES, 324 MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·June 11, 2018
Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part: ONE SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx90'' 1-PATIENT HOSE 22mmIDx18'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 84'' w/CUFF 1/4''ID 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code CBK·December 6, 2004
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
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015