19 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RUSCH
FDA UDI
TELEFLEX INCORPORATED·04026704319589·SLICK SET CUFFED STERILE
STAINLESS STEEL FEMORAL NAILING SYSTEM
FDA UDI
ORTHOFIX SRL·18032568033588·INTERNAL TEMPLATE D 12 MM FEMORAL NAIL
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987168746·CORTICAL SHANK, Cannulated, 7.0 X 75
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981168742·CORTICAL SHANK, Cannulated, 7.0 X 75
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Enforcement
Class II
·Completed·Teleflex Medical Europe Ltd·August 25, 2021
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Recall
Open, Classified
·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
Manual TruCut Biopsy Cannula
FDA UDI
Möller Medical GmbH·04260277173371·
Widex
FDA UDI
Widex A/S·05706069896039·WIDEX EVOKE E-FA (Lime green ) 30, Telecoil, Vo...
CURRENT RF DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
RESTYLANE L, RESTYLANE LIDOCAINE
FDA Adverse Event
Injury
·Q-MED·Product code LMH·June 5, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·June 17, 2011
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
MAGNETOM Skyra fit. Model Number: 10849580.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·February 1, 2023
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012