16 results
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26ms
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Sources: EU EUDAMED, US FDA
MODIFIED ENDOBRONCHIAL TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
SureStep™ Foley Tray System Bard® All Silicone Foley Catheter Tray
FDA UDI
C. R. Bard, Inc.·00801741104589·SureStep® Foley Tray System (Bard Silicone Fole...
Bard® Urine Meter Tray with Bardex® All Silicone Foley Catheter
FDA UDI
C. R. Bard, Inc.·00801741020193·Bard® Urine Meter Tray with Bard EZ-Lok®Samplin...
OMEGA
FDA UDI
Stryker GmbH·07613154482498·Basic Cortical Screw Rack
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978079981·TEMPLATE 902-116 16MM
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981142230·Mariner Implant Tray, Lateral Connector Caddy
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123137·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 150mm
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707051730·.022 U6L DBT/NC -10T 5 OFF
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
EASYCELL CELL LOCATOR
FDA 510(k)
FDA Class 2
·Hematology
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 8, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR-REDWOOD CITY·Product code MGB·November 10, 2010
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 24, 2014
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
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024