16 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RUSCH
FDA UDI
TELEFLEX INCORPORATED·04026704319565·SLICK SET CUFFED STERILE
SCOVILLE LUMBAR BLADE
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896037748·SCOVILLE LUMBAR BLADE
OsteoMed
FDA UDI
OSTEOMED LLC·00845694004626·SpectrumTM Large Horizontal Bow
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
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981168728·CORTICAL SHANK, Cannulated, 7.0 X 65
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987168722·CORTICAL SHANK, Cannulated, 7.0 X 65
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
SPAULDING IQ ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
AMS SINGLE INCISION SLING SYSTEM (SIS-0)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 14, 2013
POLY-L-LACTIC ACID (POLY-L-LACTIC ACID)
FDA Adverse Event
Injury
·AVENTIS PHARMA GRUPPO LEPETIT S.R.L.·Product code LMH·July 13, 2011
COMPLETE MULTI-PURPOSE
FDA Adverse Event
Other
·ADVANCED MEDICAL OPTICS INC.·Product code LPN·September 21, 2008
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code BTR·May 25, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012