58 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SAVANNAH
FDA UDI
SPINAL ELEMENTS·00840916151669·LARGE T-HANDLE WITH AO CONNECTION GAUTHIER (G30...
ELMED
FDA UDI
ELMED INCORPORATED·00842180156562·GOULET-SIMPSON RETRACTOR, SMALL, 1”
Barostim
FDA UDI
CVRX, INC.·00859144004630·Model 9020 Barostim Programmer System
Overdenture Gold/Plastic Coping
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307109143·
Multi-Unit Abutment Gold/Plastic Coping
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307126270·
AngelMed Guardian Programmer Wand EXD Model EXD-001
FDA UDI
Avertix Medical Inc.·00850012625070·PROG-003 Wand
Zavation
FDA UDI
Zavation LLC·00842166195233·Disc Prep Case 2 Assembly
EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523156382·Size 6 Up-Angled Cup Curette Silicone Handle
BodyForm™
FDA UDI
Seaspine Orthopedics Corporation·10889981057732·Thoracic 67mm Plate
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494460661·Bone Chisel
Knurled Handle Steel
D 3.0mm x 310mm
UNKNOWNARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 7, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 28, 2025
BodyForm™ Thoraco-Lumbar
FDA UDI
Seaspine Orthopedics Corporation·10889981048174·Thoraco-Lumbar 67mm Plate (BFP-25-0-C)
UNKNOWN TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 7, 2022
UNKNOWN FIXED LATERAL OXFORD FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 7, 2022
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·May 8, 2013
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·September 18, 2014