9 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EW10-EC02 Endoscopy Support Program
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Baby-Cooley Clamp 14.5cm angled
FDA UDI
Geister Medizintechnik GmbH·04057034063019·Baby-Cooley Clamp 14.5cm angled
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k)
FDA Class 1
·General Hospital
IPACS PRISM
FDA 510(k)
FDA Class 2
·Radiology
SABERX RADIANZ
FDA Adverse Event
Malfunction
·CORDIS US. CORP·Product code LIT·August 15, 2025
JAGTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 28, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 23, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021