11 results
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25ms
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Sources: EU EUDAMED, US FDA
PERSONAL DEFIBRILLATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
CVS Health
FDA UDI
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED·00050428277447·Hydrogel Burn Pads, all one size, 1.96 IN x 2.9...
MYOSYSTEM WITH CUSTOMIZING
FDA 510(k)
FDA Class 2
·Neurology
ULTRA RENEW PLUS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·October 9, 2013
HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTROD
FDA Adverse Event
Malfunction
·Product code LJS·March 17, 2014
CADIERE FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 14, 2012
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 13, 2010
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 2024
The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·July 20, 2016
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018