11 results · 20ms · Sources: EU EUDAMED, 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