13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vitality® Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Vanguard® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304271586·
STRAUMANN DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
YOBOSHI DENTAL UNIT
FDA 510(k)
FDA Class 1
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 14, 2025
TINBN VANGUARD INT PS ANAT FM R 65MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·March 7, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 18, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 29, 2011
OT VERIO IQ METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
T2 STRATOSPHERE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·July 1, 2020
XP-XP Tibial Tray - Interlok 75 mm Item # 195757
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-300V09 103-0601-300V11 103-0602-300V10 103-0601-350 103-0602-350 103-0601-350V01 103-0602-350V01 103-0601-350V06 103-0602-350V02
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20028871/NextSeq 550Dx HO FC Cart v2.5, 300 Cycles, REF: 20026365; CN NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20064341/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 20064344/CN NEXTSEQ 550Dx HO FLOW CELL V2.5, REF: 20062316; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (150 cycles) IVD, 20064345/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; CN NextSeq 550Dx Mid Output Reagent Kit v2.5 (300 cycles) IVD, 20064346/CN NEXTSEQ 550Dx MO FLOW CELL V2.5, REF: 20062530; /FLOWCELL, FIT FLUIDICS TESTING, REF: 15050205
FDA Enforcement
Class II
·Ongoing·Illumina, Inc.·December 10, 2025