19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PMMA Block
FDA 510(k)
FDA Class 2
·Dental
HHM
FDA UDI
Oticon A/S·05707131357236·G500 SC, MINIRITE R LI-ION 2.4G C057 HHM
CODMAN
FDA UDI
Cerenovus, Inc.·10886704001645·CODMAN SLIM-LINE Aneurysm Clip Sharp Right Angl...
NA
FDA UDI
Synthes GmbH·10886982142504·2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 13MM
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512770·"An absorbent paper points is an endodontic pap...
SYSMEX R-500
FDA 510(k)
FDA Class 2
·Hematology
CINESCAN S
FDA 510(k)
FDA Class 2
·Radiology
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2022
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 30, 2011
GE OEC 6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·June 28, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 9, 2012
CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 10, 2024
INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022
INSPIRE 7F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL.·Product code DTZ·March 12, 2024
INSPIRE 7F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·June 24, 2025
INSPIRE 7F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·February 5, 2025
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