22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
FDA 510(k)
FDA Class 2
·Radiology
SSW CARBIDE TRIMMING AND FINISHING
FDA UDI
Ss White Burs, Inc.·D6901600652·10 BLADE FINISHING CARBIDE SAFE END SE3 - 5 PACK
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319705353·Baby Webster Needle Holder 4-3/4 (11.9cm), extr...
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981168353·CORTICAL SHANK, Cannulated, 6.0 X 65
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987168357·CORTICAL SHANK, Cannulated, 6.0 X 65
Apelo® / Apelo® MIS
FDA UDI
ATLAS SPINE, INC.·M68111001600650·5.5mm x 65mm MIS Contoured Rod
MECTALIF ANTERIOR MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANC
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·July 5, 2019
SPAULDING IQ ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523129638·6.5 mm Implant Caddy Lid for 6.0 mm Rod
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 23, 2025
STANDARD CRANIOTOME, BLACKMAX
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GFF·June 10, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 13, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·December 16, 2022
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X25 ENHANCED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·April 17, 2019
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·September 3, 2019
MECTALIF ANTERIOR STAND-ALONE PLATE FLUSH H.12 MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·March 29, 2018
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·September 2, 2019
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCED
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code OVD·September 20, 2018