11 results
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26ms
·
Sources: EU EUDAMED, US FDA
ENDOPORT 5MM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Endodontic Hand Instruments
FDA UDI
TULSA DENTAL PRODUCTS LLC·D71668520311·HEDSTROM READY STEEL 31MM 020
ReadySteal Hedstrom File
FDA UDI
TULSA DENTAL PRODUCTS LLC·D71668520312·Ready Steal Hedstrom File Size 6852031 Length
LEONE SPA
FDA UDI
LEONE SPA·08033707030775·WEB 1ST MOL BANDS W/G8325-02 UR 31
New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POWDERED LATEX SURGEON'S GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SMALL BATTERY DRIVE II
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·June 5, 2014
UNKNOWN DEPUY ASR ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 30, 2012
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 28, 2010
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