88 results · 31ms · Sources: EU EUDAMED, US FDA

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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