24 results · 33ms · Sources: EU EUDAMED, US FDA

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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