16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
FDA 510(k)
FDA Class 2
·Orthopedic
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HRS·January 30, 2017
Oticon
FDA UDI
Oticon A/S·05707131286048·NERA2 PRO TI, RITE 312 WL DBL
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120465·Guidewire 0.9x150mm Dbl Trocar
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100035·BARRAQUER HEAVY WIRE SPECULUM LARGE
SunMed
FDA UDI
SUNMED, LLC·20889483000387·Large Adult Traditional Guedel Airway
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
ORAL/ENTERAL SYRINGES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014
BARD PARKER
FDA Adverse Event
Malfunction
·ASPEN SURGICAL PRODUCTS, INC.·Product code GES·April 25, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011
Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 7, 2018
Axiom Artis fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 22, 2017
Artis Zee and Zeego fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 22, 2017
Artis Q and Q.Zen fluoroscopic x-ray system
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 22, 2017
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024