BEUDAMED
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    FDA UDI
    SOUTHERN IMPLANTS (PTY) LTD·06009544038955·Sleeve Guided Surgery 06.2 x 4mm

    2.5MM DRILL BIT/QC/GOLD/110MM

    FDA Adverse Event
    Injury ·SYNTHES BETTLACH·Product code HWE·November 6, 2017

    ANESTHESIA MACHINE

    FDA Adverse Event
    Malfunction ·NORTH AMERICAN DRAGER·Product code GSZ·March 20, 1996

    Antigens, Febrile (Weil-Felix), All Groups

    FDA classification
    FDA Class 1 ·Antigens, Febrile (Weil-Felix), All Groups

    Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which is placed, during arthroplasty, in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes to meet various anatomical variations and is supplied sterile. Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Osteotec Limited·August 6, 2025

    OSUNG MND

    FDA UDI
    OSUNG MND Co., Ltd.·08800075607379·A hand-held dental instrument designed for remo...

    Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which is placed, during arthroplasty, in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes to meet various anatomical variations and is supplied sterile. Component: N/A

    FDA Recall
    Open, Classified ·Osteotec Limited·Product code KYJ·June 18, 2025

    GSB LLC

    FDA registration
    GSB LLC·1 product·🇺🇸 United States

    GMZ ASSOCIATES, LTD.

    FDA registration
    GMZ ASSOCIATES, LTD.·1 product·🇺🇸 United States

    TECNO-GAZ S.P.A.

    FDA registration
    TECNO-GAZ S.P.A.·1 product·🇮🇹 Italy

    NA

    FDA UDI
    SOUTHERN IMPLANTS (PTY) LTD·06009544027720·Cover Screw for Int. Hex

    NA

    FDA UDI
    Fehling Instruments GmbH & Co. KG·04058749010312·CERAMO micro scissors, bayonet half-ptd., sligh...

    NA

    FDA UDI
    Fehling Instruments GmbH & Co. KG·04058749010305·CERAMO micro scissors, bayonet half-ptd., strai...

    GSO GS1 SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GSO GS1 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GSA GENITO SENSORY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Neurology

    GSO GS1 CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GENERAL SEMEN ANALYSIS (GSA) KIT

    FDA 510(k)
    FDA Class 2 ·Hematology

    NA

    FDA UDI
    SOUTHERN IMPLANTS (PTY) LTD·06009544037507·Screw brass Hex ø3.3 PRO M1.6

    NA

    FDA UDI
    SOUTHERN IMPLANTS (PTY) LTD·06009544001904·Hexed Brass Screw for Int. Hex