23 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2
FDA 510(k)
FDA Class 2
·Cardiovascular
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809866827·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
FDA 510(k)
FDA Class 2
·Cardiovascular
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 21, 2025
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75 X 14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75X14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 2, 2013
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·April 6, 2011
MERIDIAN DR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67X14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
VANGUARD DA 360 TIBIAL BEARING ARCM 71/75X16
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 28, 2017
VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·February 6, 2017
VG DA360 TIB BRG ARCM 79/83X14 3 X 14MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·October 31, 2017
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 2, 2017
VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 13, 2016
VANGUARD DA 360 TIBIAL TRAY
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 27, 2017
VANGUARD SSKPSC TIBIAL BEARING S 12X63/67
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 21, 2017
VANGUARD DA360 TIBIAL BEARING ARCOM 63/67X18
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 9, 2017
PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. 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