15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SonoFlow Sonohysterography and Sonohysterosalpingography Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071134242·14FR x 2.5 cm x 45 cm Low Profile Transgastric-...
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071101763·14FR x 2.5 cm x 45 cm Low Profile Transgastric-...
FM-02 BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
HOVEROUND MPV-5 POWERCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071116897·14FR x 2.5 cm x 45 cm Low Profile Transgastric-...
G-Jet® Transgastric-Jejunal Feeding Device
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071134259·14FR x 2.5 cm x 45 cm Low Profile Transgastric-...
HIRES 90K IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS, LLC·Product code MCM·October 1, 2014
PELVICOL ACELLULAR COLLAGEN MATRIX
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTL·April 19, 2013
TAXUS (R) LIBERTÉ (R)
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 28, 2011
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015