16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310215333·FG Diamond 856-018 round end taper regular 5/pack
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526189782·***DISC***LEVAMED ACTIVE ANKLE SUP BL
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854005224·ULTRAPOWER BUR, ROUND (PURPLE), 10 MM
SURGIFLATOR-40
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEPUY FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
RUBY COIL
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 22, 2019
TAXUS¿ ELEMENT¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 26, 2013
ARCHITECT HAVAB IGM REAGENT
FDA Adverse Event
Malfunction
·ABBOTT·Product code LOL·March 17, 2011
BARD MINI-FUSER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·March 26, 2008
PX SLIM DELIVERY MICROCATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·November 22, 2019
RUBY COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·November 22, 2019
RUBY COIL
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·November 22, 2019
Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·November 28, 2018
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
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014