3,182 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GXR-Series Diagnostic X-Ray System
FDA 510(k)
FDA Class 2
·Radiology
MITEK
FDA UDI
Medos International Sàrl·10886705029167·HD EP Arthroscope/Sinuscope compatible with Mit...
Ophthalmic Scissors
FDA UDI
KATENA PRODUCTS, INC.·00841668105207·HOLLAND DALK SICISSORS LEFT
Symmetry Charnley
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482061206·Symmetry® Blade; Charnley Retractor; Rounded; 1...
Portex
FDA UDI
ICU MEDICAL, INC.·15019517071443·
Maven Patient-Specific Instrumentation
FDA 510(k)
FDA Class 2
·Orthopedic
HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 10, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 9, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013
NI
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·July 24, 2019
NI
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·July 24, 2019
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OZO·November 6, 2019
CADD LEGACY 1 PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC·Product code FRN·May 28, 2019
AMS INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - MINNETONKA·Product code FHW·August 21, 2017
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·July 23, 2019
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 25, 2019
NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·June 23, 2019
NGAGE NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code FFL·February 25, 2019
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·November 13, 2019