13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
FDA 510(k)
FDA Class 2
·Hematology
GYRUS ACMI, INC
FDA UDI
Gyrus ACMI, LLC·00821925016026·SHEA-ROBERTSON MIRROR MIDDLE-EAR
LINK Instruments - Impactors, extractors and insertion
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575347070·Hip prosthesis socket pusher - Cemented Acetabu...
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COMP A-I-R
FDA 510(k)
FDA Class 2
·Anesthesiology
GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015
GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 24, 2013
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·September 30, 2014
KAPPA 400 SR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011
Affixus¿ Hip Fracture Nail 130¿ 11 mm x 180 mm, Item Number: 814511180
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015