44 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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SYNGO CT DYNAMIC ANGIO
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
Tyber Medical, LLC·M695M1203310·
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331601·IN-OVATION® C Roncone 018 UL/ 3-3 CS HK
IN-OVATION® C
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100331101·IN-OVATION® C Base Rx 018 UL/3-3 CS HK
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PASCO MIC AND MIC/ID PANELS
FDA 510(k)
FDA Class 2
·Microbiology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 28, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 21, 2017
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 17, 2023
PENUMBRA SMART COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·December 11, 2015
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 10, 2011
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
BALL HEADS: COCR BALL HEAD 12/14 32 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·January 8, 2021
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 1 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·February 27, 2014
VERSAFITCUP CC TRIO ACETABULAR SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 26, 2026
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 20, 2024
VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 23, 2017
CUP: VERSAFITCUP CC TRIO Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 2, 2019