94 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
ArgenPMMA Multi 98x12-D4
FDA UDI
ARGEN CORPORATION, THE·D818120953·Crown And Bridge, Temporary, Resin
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704189·Castroviejo Micro Suturing Forceps 4" (10cm), w...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450299036·
MICROLIFE NON-CONTACT INFRARED FOREHEAD THERMOMETER, MODEL FR1DZ1
FDA 510(k)
FDA Class 2
·General Hospital
HEPARIN DOSE RESPONSE CARTRIDGE
FDA 510(k)
FDA Class 2
·Hematology
HAHN TAPERED IMPLANT Ø5.0 X 13 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·October 5, 2023
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 20, 2013
LAMITRODE TRIPOLE 16 LEAD, 60 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 9, 2011
ACCU-CHEK RAPID D INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·August 13, 2008
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 11, 2019
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·October 11, 2019
ENDURO MENISCAL COMPONENT F2 22MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code KRO·December 9, 2014
ENDURO MENISCAL COMPONENT F2 10MM
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO. KG·Product code KRO·January 14, 2015
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·April 29, 2019
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·May 15, 2013
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·January 31, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·January 17, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·January 3, 2020
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·February 4, 2020