35 results
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19ms
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Sources: EU EUDAMED, US FDA
Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))
FDA 510(k)
FDA Class 2
·Anesthesiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613018016·K-Wire, Single Ended, Trocar Point, Diameter Si...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306806131·Four Sided Specula, Pederson, 10 x 2.5cm
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250625200·ceraMotion® Zr 3D Dentin CC52, 20 g / dental ce...
DM
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·06975384335557·5 pieces
DM
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·16975384335554·5 pieces
KP
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·16975384334434·5 pieces
KP
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·06975384334437·5 pieces
VARELISA RECOMBI ANA PROFILE, MODEL 18496
FDA 510(k)
FDA Class 2
·Immunology
Morrison Steerable Needle
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KP
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·06975384335113·5 pieces
KP
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·16975384335110·5 pieces
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 11 MM DIAMETER - 100 MM LE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·November 14, 2008
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·September 16, 2011
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 26, 2013
One Step K in vitro diagnostic test REF: 81A4
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step UTI in vitro diagnostic test REF: 3374
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step 10A in vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step pH in vitro diagnostic test REF: 31I4P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·October 15, 2025