13 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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STACKHOUSE LENS HOOD, MODEL SA-700/FS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159019032·Jacobson Micro Needle Holder Round Handle
NA
FDA UDI
STRYKER CORPORATION·04546540401854·Micro Dual Cut (7.0 x 0.38 x 20.0mm)
NA
FDA UDI
STRYKER CORPORATION·04546540466563·Precision Thin, Offset (7.0 x 0.38 x 20.0mm)
STERICHEK TOTAL CHLORINE REAGENT STRIPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DIGITAL INFLECTION RIGIDOMETER (DIR)
FDA 510(k)
FDA Unclassified
·Unknown
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·February 22, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 22, 2008
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024