26 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004
FDA 510(k)
FDA Class 2
·Neurology
Double Pump Day cassette/ Double Pump RF Day cassette
FDA UDI
INSIGHTRA MEDICAL, INC.·07350021981004·
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000663605·PLATE 3002053 ZEVO 53MM 2 LVL
ZEVO™ Anterior Cervical Plate System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169330047·PLATE 3002053 ZEVO 53MM 2 LVL
Preat
FDA UDI
Preat Corporation·00842092182628·ASC Astra 3.0mm-Compatible Titanium Screw
artVeneer life
FDA UDI
Merz Dental GmbH·D7092002053·artVeneer life lower posteriors, L, B1
GRADIA®
FDA UDI
Gc America Inc.·14548161074223·GRADIA® DIRECT Syringes: 1 syringe (2.7mL) DT
GRADIA®
FDA UDI
Gc America Inc.·D0470020531·GRADIA® DIRECT Syringes: 1 syringe (2.7mL) DT
SCREWDRIVER, SHORT 3,5 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·March 22, 2016
MAMMARY PROSTHESIS
FDA Adverse Event
DOW CORNING CORP.·Product code FTR·May 18, 1994
SILASTIC MAMMARY PROSTHESIS
FDA Adverse Event
DOW CORNING CORP.·Product code FTR·May 18, 1994
ACL 9000 SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
SILENT NIGHT V
FDA 510(k)
FDA Class 2
·Anesthesiology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523185009·Straight Rasp Trial, 60mm x 22mm x 4mm x 0°
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523145928·Pituitary, 380mm, Straight, 6mm
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·May 11, 2021
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·March 13, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 28, 2011
DEPUY ORTHOPEDICS
FDA Adverse Event
Injury
·DEPUY·Product code JWH·February 21, 2008
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014