15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS
FDA 510(k)
FDA Class 2
·Immunology
Bard® Foley Tray with Hydrophilic-Coated Foley Catheter
FDA UDI
C. R. Bard, Inc.·00801741040399·Bard® Foley Tray with Hydrophilic-Coated Foley ...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694025331·EnCompass 16mm Drill Guide
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM51008613140161·Rotary diamond instrument for dental application
Rib Retractor
FDA UDI
KOROS U.S.A., INC.·10840199536211·Rib Spreader Adolescent Size 5, 4-3/4" Arm Leng...
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746030901·SUPPLIES - LAMINATED BITE WAFER 84/PKG
Supplies
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746162787·SUPPLIES - LAMINATED BITE WAFER 84/PKG
Laminated Bite Wafers
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746034930·SUPPLIES - LAMINATED BITE WAFER 84/PKG
Z-Clamp ISP System
FDA 510(k)
FDA Class 2
·Orthopedic
EBI ESL PEEK-OPTIMA SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PS TIBIAL INSERTS SZ 2, 26MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 22, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 10, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 7, 2010
INTERLOCK¿-35
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KRD·December 6, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012