10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYELOGRAPHY NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
FDA 510(k)
FDA Class 2
·General Hospital
Electric breast pump (model: M5)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LOGIC CR TIB INSERT STD, SZ 3, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 30, 2024
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·November 16, 2007
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·February 20, 2014
UNKNOWN DEPUY ASR IMPLANTS
FDA Adverse Event
Malfunction
·DEPUY INTL LTD·Product code KWA·December 10, 2010
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015