12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line
FDA 510(k)
FDA Class 2
·Anesthesiology
TechLITE Pen Needle 4mm x 32g Sample 10's
FDA UDI
ARKRAY USA, INC.·00015482230326·Sterile Single-Use Pen Needle samples. Intende...
Philips
FDA UDI
Sbo Hearing A/S·05714464034659·Philips HearLink Connect 3.4.0 iOS
Ricca Chemical Company®
FDA UDI
Ricca Chemical Company, LLC·00192024025746·Copper Sulfate, 1.055 Specific Gravity at 25°C ...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776401559·3.2mm, 7cm, Trocar, Blunt
ULTHERA SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLV CONTINUUM VENTILATOR, MODEL P2000
FDA 510(k)
FDA Class 2
·Anesthesiology
G7 LONGEVITY NEUTRAL 36MM F
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·October 6, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 29, 2011
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 11, 2013
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017