19 results
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36ms
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Sources: EU EUDAMED, US FDA
CENTRIFICHEM HDL CHOLESTEROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACUMED
FDA UDI
Acumed LLC·10806378046889·4.3mm QR Drill, Long
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209117314·
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016159·ROD CONNECTOR, PARALLEL CLOSED 16mm OFFSET, Ø 5...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016135·ROD CONNECTOR, PARALLEL CLOSED 12mm OFFSET, Ø 5...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016166·ROD CONNECTOR, PARALLEL CLOSED 18mm OFFSET, Ø 5...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016128·ROD CONNECTOR, PARALLEL CLOSED 10mm OFFSET, Ø 5...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016142·ROD CONNECTOR, PARALLEL CLOSED 14mm OFFSET, Ø 5...
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KYMCO FORU, MODEL EQ40
FDA 510(k)
FDA Class 2
·Physical Medicine
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 16, 1998
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 8, 2014
CUSTOM PAK
FDA Adverse Event
Malfunction
·ALCON - HOUSTON·Product code KYG·October 17, 2012
LIFEPAK CR(R) PLUS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·May 28, 2015
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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
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