88 results
·
31ms
·
Sources: EU EUDAMED, US FDA
HS1 DEFIBRILLATOR, FRENCH, EXCHANGE
FDA Adverse Event
Malfunction
·PHILIPS NORTH AMERICA LLC·Product code MKJ·February 21, 2023
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Philips HeartStart FR3 Defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FR3 Primary Battery (989803150161)
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FR3 Defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FR3 Defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FR3 Defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FR3 Defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Philips HeartStart FR3 Defibrillator
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·HeartStart FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035705·Drill Sleeve, 6.5mm/7.3mm
VIVID POST WHITE
FDA UDI
BIOLOREN SRL·08056099233159·Conical fiberglass posts ø 1.4 - 1.85 mm.
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05061075022781·KLEOS PSL METAL MBT 022 LR5 HK PK5
Widex
FDA UDI
Widex A/S·05706069898095·WIDEX EVOKE E-CIC (Clay brown ) 50, Right, RC coil
Widex
FDA UDI
Widex A/S·05706069897807·WIDEX EVOKE E-XP (Clay brown ) 50, Telecoil, RC...
Stent, Renal
FDA Pre-Market Approval
FDA Class 3
·FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FDA Pre-Market Approval
FDA Class 3
·MENTOR MEMORYSHAPE BREAST IMPLANTS
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code NIN·March 29, 2017
FORMULA 414 RX RENAL BALLOON-EXPANDABLE STENT
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code NIN·February 16, 2017
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
LTC MED SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 10, 2013