35 results · 19ms · Sources: EU EUDAMED, US FDA

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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