38 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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S57D DIGITAL OPERATING ROOM CAMERA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004028·PowerChem Neoprene Exam Gloves, Small
CUSTOM PROCEDURE KIT
FDA UDI
MEDIVATORS INC.·40677964004405·The ENDO CARRY-ON Procedure Kit contains all of...
CURE 2.0 ACP
FDA UDI
SpineArt SA·07640332475485·DOUBLE BARREL DRILL GUIDE 2 - VARIABLE
CURE 2.0™ ACP
FDA UDI
MEDITECH SPINE, LLC·B1671000422000·
ESU Sensor
FDA UDI
I.C. MEDICAL, INC.·00817688021742·
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X (1,3 OR 6 STRIPS PER BOX)
FDA 510(k)
FDA Class 2
·Orthopedic
HARDYDISK CEFAMANDOLE, 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·September 10, 2014
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·May 6, 2024
SIEMENS : ARTISTE MV
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·July 30, 2010
CARDIOSAVE HYBRID, TYPE G PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·July 30, 2025
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·March 12, 2013
MAXIMO II CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·February 24, 2011
KYPHX HV-R BONE CEMENT
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC·Product code NDN·February 21, 2008
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 29, 2018
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code PQF·April 29, 2018
EVIS EXERA III DUODENOVIDEOSCOPE
FDA Adverse Event
Injury
·AIZU OLYMPUS CO., LTD.·Product code FDT·September 27, 2024
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·March 4, 2022
BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015