12 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HORIZONS REUSABLE POLYPECTOMY SNARES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496022268·WONDER MODEL 140 OPAQUE, SIZE L, FUMO, GRADUATE...
OneTouch Verio IQ
FDA UDI
LifeScan Europe GmbH·00353885007719·OneTouch Verio IQ Blood Glucose Monitoring Syst...
TRIMAX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ANCA SLIDE
FDA Adverse Event
Injury
·INOVA DIAGNOSTICS, INC.·Product code MOB·July 13, 2000
STRAIGHT BALL TIP PROBE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·March 26, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 28, 2011
EMBRACE PUMP
FDA Adverse Event
Malfunction
·ROSS PRODUCTS DIVISION·Product code LZH·March 26, 2008
OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Number: 72203290
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014