12 results
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25ms
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Sources: EU EUDAMED, US FDA
SAF SINGLE-USE AEROSOL FILTER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ERA® RV 4.5 Partial Offset Attachment
FDA UDI
STERNGOLD DENTAL LLC·00841549101182·Extracoronal semi-precision attachment. Content...
ri-scope® L ophthalmoscope L2 LED 3,5V, C handle
FDA UDI
Rudolf Riester GmbH·04045396182684·The Riester ophthalmoscope is produced for the...
AURADONICS
FDA UDI
AURADONICS INC.·00810033836244·LATEX ELASTICS 3/16" 2.5 oz. - AMBER, 100000 ea...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112030·Tap, 5.5 mm
Green OR Reprocessed Aquamantys Bipolar Sealer
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Juliet Ti
FDA 510(k)
FDA Class 2
·Orthopedic
DRIVING CAP/THREADED
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·October 7, 2020
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 9, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 2, 2015
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 60161793, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·March 4, 2015