16 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HAIRMAX LASERCOMB
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777501·LUMBAMED PLUS FLEX PAD M SILVER III
LEONE SPA
FDA UDI
LEONE SPA·08033707097518·BKT 33 INTERACTIVE SL 22 T-6 A+3 BH
ProGuide Needles
FDA UDI
Nucletron B.V.·08717213025202·ProGuide Round Needle 6Fx294mm
ProGuide Needles
FDA UDI
Nucletron B.V.·08717213053762·ProGuide Round Needle 6Fx294mm
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642118025·Modular Spacer, 38 mm (W) x 28 mm (L) x 13 mm (...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197539807·Love Gruenwald Laminectomy Ronguer downw
ards a...
POWDER FREE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SUDOSCAN
FDA 510(k)
FDA Class 2
·Neurology
BD PHASEAL¿ INFUSION ADAPTER C100
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·March 30, 2022
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 13, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·September 10, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011
INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
Spectral CT. Computed tomography X-ray system.
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 2, 2025
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015