4,237 results
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46ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Modo, Inc.
FDA registration
Modo, Inc.·6 products·🇺🇸 United States
Modo Inc.
FDA registration
Modo Inc.·5 products·🇺🇸 United States
MODO INC
FDA registration
MODO INC·10 products·🇺🇸 United States
HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./MODOS S.A.·Product code JXG·January 2, 2002
HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./MODOS S.A.·Product code JXG·June 8, 2001
Hospira Accessory Power Pack; a 4 outlet power strip with a custom pole clamp bracket to attach to the IV pole with the infusion pump; Distributed by: Hospira, Inc., 275 N. Field Drive, Lake Forest, IL 60045; part number 39003-04-01, Modo #HSP1700, Model Tripp-Lite PS-415-HG Accessory power pack used for use with medical devices.
FDA Recall
Terminated
·Hospira Inc.·Product code FRN·July 2, 2010
CURLIN 6000
FDA Adverse Event
Malfunction
·MOOD / ZEVEX, INC.·Product code FRN·October 30, 2024
ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. For in vitro diagnostic use in the calibration of A1c_3 (A1c_3 and A1c_3M) and Total Hemoglobin_3 (tHb_3 and tHb_3M) methods on ADVIA¿ Chemistry systems.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics·September 11, 2013
HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. MEDOS·Product code JXG·March 31, 2004
EXPEDIUM FENESTRATED SCREW OPEN CANNULA
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL / DEPUY, INC.·Product code MNI·April 17, 2019
HAKIM INLINE PROGRAMMABLE VALVE SG
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC. / MEDOS·Product code JXG·April 6, 2006
CODMAN BACTISEAL EVD CATHETER
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. / MEDOS·Product code JXG·July 30, 2009
NEUROMONITOR BASIC KIT
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC./MEDOS·Product code GWM·May 19, 2008
CODMAN CERTAS SIPHONGUARD
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÀRL/ DEPUY INC.·Product code JXG·September 26, 2017
CERTAS INLIN VLV ONLY W/SPHNGD
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC MEDOS·Product code JXG·November 5, 2013
CERTAS INLIN VLV ONLY W/SPHNGD
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC MEDOS·Product code JXG·November 5, 2013
CODMAN CERTAS INLINE VLV
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC MEDOS·Product code JXG·November 5, 2013
CODMAN VPV SYSTEM
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC MEDOS·Product code JXG·October 3, 2013
Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland), Inc.·November 14, 2012
NEUROMONITOR BASIC KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code GWM·December 1, 2016