18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Electric Breast Pump
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OsteoMed
FDA UDI
OSTEOMED LLC·00842528128923·2.4mm x 13mm Cannulated Lag Screw
FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
RI MSC (MIGRATION SEDIMENTATION CHAMBER)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·January 6, 2020
TRUWAVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025
MULTI-LINK 8
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·June 21, 2013
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·July 28, 2011
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 8, 2014
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·September 2, 2020
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025
TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 125°
FDA Adverse Event
Death
·STRYKER TRAUMA KIEL·Product code HSB·September 29, 2015
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
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
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014