BEUDAMED
    49 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

    FDA Enforcement
    Class II ·Ongoing·Surgical Theater Inc·November 5, 2025

    Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Philips North America·December 17, 2025

    DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.

    FDA Enforcement
    Class II ·Terminated·Implant Direct Sybron Manufacturing, LLC·December 16, 2015

    Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE NAIL NIPPER, Product Code 67110; f) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code 67285; g) STERILE 5 1/2" NAIL NIPPER (32195), Product Code 67365; h) STERILE 4 1/4" CUTICLE NIPPER (32908), Product Code 67420; i) STERILE ENGLISH ANVIL NAIL SPLITTER-5", Product Code 67595; j) STERILE UNIVERSAL RING CUTTER(FS02470), Product Code 67780; k) STERILE FINGER NAIL CLIPPER, Product Code 589784ST; l) BILLEAU EAR LOOP 4MM 6" LARGE, Product Code BEL46ST; m) PROBE WITH EYE, Product Code DYND04011; n) STERILE 9" MAYO SCISSOR (ST150), Product Code I67350; o) STRL ROCHESTER OCHSNER SATIN 7 1/4", Product Code I67695; p) CMP* NAIL NIPPER ANGLED 4.5, Product Code I67980; q) STERILE BILLEAU EAR LOOP 3MM, Product Code I67995; r) ST. ALLIGATOR FORCEP, POINTED, MICRO P/S, Product Code I68020; s) MOSQUITO HEMOSTAT FINE TIP, Product Code I68190; t) STERILE VAS DEFERENS CLAMP (VDC100S), Product Code I68200; u) LILLIE EAR HOOK, 7" STERILE (P/S), Product Code I68305; v) ST FOX DERMAL CURE, 4MM, 5 1/2 (32922), Product Code I68360; w) STERILE SKIN HOOK - SHARP (SH25754), Product Code I68415; x) ST. EYE LID SPECULUM WIRE ADULT (ES500P), Product Code I68460; y) STERILE NAIL RASP DOUBLE ENDED (NR100), Product Code I68500; z) ST. SCLERAL DEPRESSOR 5.5" (SD500), Product Code I68515; aa) STERILE NAIL SPLITTING FORCEP 4" (NS400), Product Code I68600; bb) STERILE 12" PROBE W/ EYE, Product Code I68840; cc) COMEDONE EXTRACTOR, STERILE (P/S), Product Code I86540; dd) STERILE SPATULA & PACKER, Product Code I86695; ee) STERILE - PHLBCTMY HOOK CRCHT STYL 6, Product Code I86875; ff) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code P-67285 MEDLINE PROBE WITH EYE, Product Code DYND04011

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·April 10, 2024

    Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·September 29, 2021

    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

    FDA Enforcement
    Class II ·Terminated·MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK·December 24, 2014

    Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·August 8, 2012

    GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

    FDA Enforcement
    Class II ·Ongoing·GRAMERCY EXTREMITY ORTHOPEDICS·April 26, 2023

    Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together.

    FDA Enforcement
    Class II ·Terminated·Best Sanitizers Inc·September 14, 2016

    Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·December 7, 2016

    Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.

    FDA Enforcement
    Class II ·Terminated·BEST THERATRONICS LTD.·August 3, 2016

    HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 15, 2017

    HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

    FDA Enforcement
    Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

    CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST

    FDA Enforcement
    Class II ·Ongoing·Carefusion 2200 Inc·November 23, 2022

    Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component.

    FDA Enforcement
    Class II ·Ongoing·Treace Medical Concepts, Inc.·September 4, 2024

    CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST

    FDA Enforcement
    Class II ·Ongoing·Carefusion 2200 Inc·November 23, 2022

    CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST

    FDA Enforcement
    Class II ·Ongoing·Carefusion 2200 Inc·November 23, 2022

    BD Pyxis Mini Main REF: 349 Medication cabinet

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026

    BD Pyxis MedStation ES REF: 323 Medication cabinet

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·June 10, 2026