30 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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STERILIZATION MATS
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814794·GENUMEDI EXTRA WIDE SILVER SIZE VI
HOWARD BONE RASPATORY
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896052369·HOWARD BONE RASPATORY DOUBLE ENDED SINGLE-SIDED...
PMT CORPORATION
FDA UDI
PMT CORPORATION·00650551002741·2.2mm Drill With 2.4mm Shaft - 203mm Length Non...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A103226150·10mm H x 32mm W x 26mm L x 15 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A10322680·10m H x 32mm W x 26mm L x 8 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A103226120·10mm H x 32mm W x 26mm L x 12 degrees ALIF
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
AMISTEM H FEMORAL STEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·February 28, 2013
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 2, 2024
GALAXY G3 MINI 1.5MM X 3CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·February 3, 2022
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 24, 2016
RESTORATION ADM X3 INS 28/48
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·May 9, 2013
PULSE GEN MODEL 103
FDA Adverse Event
Death
·CYBERONICS INC·Product code LYJ·September 19, 2014
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 25, 2011
DELTAXSFT10 1.5MM X 1CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·September 22, 2021
MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018