14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TytoCare Lung Sounds Analyzer
FDA 510(k)
FDA Class 2
·Anesthesiology
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221614150·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221614070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221614000·
Symmetry Roux
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482044810·Symmetry® Retractor, Roux, 7/8 in Wide, 1 1/8 i...
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
FDA 510(k)
FDA Unclassified
·Unknown
DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020
FDA 510(k)
FDA Class 2
·General Hospital
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962113851·ROUX RETRACTOR, 7/8"X1 1/8"X5 1/2", SMALL, DOUB...
PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DYB·November 3, 2014
BLADELESS VP 12MM ST W/ FIXATION
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GCJ·August 19, 2011
NA
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DSI·July 1, 2013
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.
FDA Enforcement
Class III
·Ongoing·Alcon Research LLC·November 27, 2024
a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR; b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR; c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR; d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR.
FDA Recall
Open, Classified
·Alcon Research LLC·Product code OJK·October 15, 2024
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026