11 results
·
26ms
·
Sources: EU EUDAMED, US FDA
BARD URINE COLLECTION PRODUCTS MODIFICATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123014·K-WIRE - SINGLE TROCAR 2.0mm DIA x 150mm
SCINTILLATION GAMMA CAMERA
FDA 510(k)
FDA Class 2
·Radiology
Venue Sprint
FDA 510(k)
FDA Class 2
·Radiology
ICY HOT SMART RELIEF TENS THERAPY
FDA Adverse Event
Injury
·CHATTEM, INC.·Product code NUH·June 19, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 2, 2013
TERUMO CDI 100 MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIVASCULAR SYSTEMS CORP.·Product code DTY·December 23, 2010
+2MM LATERAL OFFSET 25MM POST LENGTH BASE PLATE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 11, 2023
14MM ÿ 130MM LENGTH HUMERAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 11, 2023
12MM HUMERAL STEM SPACER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 11, 2023
Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.
FDA Enforcement
Class II
·Terminated·Capintec Inc·April 1, 2020