11 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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Novum IQ Syringe Pump (40800BAXUS)
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Medos International Sàrl·10886705028863·LIGHT GUIDE, UNIVERSAL 5.0MM X 3.0M
Artman Instruments
FDA UDI
Wise Linkers, LLC·D1272423901·Dental Composite Shaper and Groove Former Carve...
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331160530·deschamps ligature carrier, blunt, left large c...
ETEST FOR GEMIFLOXACIN
FDA 510(k)
FDA Class 2
·Microbiology
Aduro Light Beauty Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 10, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
PKG, ALLIS FORCEPS, P/N 0250080240. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025