32 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenZ HT+ 98x16 ML A4B
FDA UDI
ARGEN CORPORATION, THE·D818130335·Dental porcelain/ceramic restoration kit
N/A
FDA UDI
Tyber Medical, LLC·M695M1303350·
selectSpacer
FDA UDI
Nucletron B.V.·08717213050013·seedSelectron Treatment Needles, Sterile / Pre-...
ORS VISUAL
FDA 510(k)
FDA Class 2
·Radiology
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
FDA 510(k)
FDA Class 1
·General Hospital
Truliant
FDA UDI
Exactech, Inc.·10885862314680·
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·February 3, 2023
TRULIANT TIB IMP CR INS STD SZ 3.5, 11 MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 6, 2023
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 28, 2026
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 22, 2013
PARADIGM REAL-TIME INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·May 9, 2011
TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 11, 2024
TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 17, 2022
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
FDA Enforcement
Class II
·Terminated·Exactech, Inc.·November 25, 2020
TRULIANT TIB IMP CR STD, SIZE 3.5, 10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 7, 2023
TRULIANT TIB IMP CRC INSERT SZ 3.5,12MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 13, 2023
TRULIANT TIB IMP CRC INSERT SZ 3.5, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 6, 2024
THREE PEG PATELLA 32MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 8, 2025