24 results
·
33ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
NA
FDA UDI
OPHTHALMED LLC·M735A2340001·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694022354·FPS Forefoot Instrument Case
Spud
FDA UDI
KATENA PRODUCTS, INC.·00841668101209·GOLF CLUB FOREIGN BODY SPUD
Ophthalmic Spoon
FDA UDI
KATENA PRODUCTS, INC.·00841668103432·LEWIS LENS LOOP SMALL
OsteoMed
FDA UDI
OSTEOMED LLC·00845694036856·FPS Small Fragment Removable Tray
Tecomet
FDA UDI
TECOMET INC.·00841435121188·SYNOVECTOMY RONGEUR STRONG CURVE
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575438365·Knee femur prosthesis trial - LINK SLED Prosthesis
Cure Catheter Closed System; Cure Dextra Closed System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 13, 2024
MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·October 21, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 31, 2011
BRILLIANCE 16 WATER
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·July 16, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 21, 2014
SPACELABS MODEL 90217 ABP MONITOR
FDA Adverse Event
Malfunction
·SPACELABS HEALTHCARE LTD.·Product code DXN·September 18, 2015
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 3, 2013
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·July 20, 2018
PUMP 1886 780G OUS BLE PUMP MG/DL
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 25, 2025