BEUDAMED
    28 results · 21ms · Sources: EU EUDAMED, US FDA

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    PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664009700·BELLA STRONG 20-30 MM HG ARMSLEEVE KNIT WELT SI...

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331170065·probe w/ eye, usa pattern, sterling silver, 6" ...

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113349·PHACO KNIFE 3.2MM ANGLED (BX/5)

    WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CARDIOHELP SYSTEM

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTQ·February 23, 2015

    DREAM STATION AUTO-CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·November 14, 2023

    INFUSE BONE GRAFT 12 MG

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code NEK·May 1, 2014

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016

    COOL PATH 7F, 1304-CP-7-25-L1-AB

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. (AF-IRVINE)·Product code OAD·April 30, 2013

    WA96 PLUS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code LRG·August 27, 2014

    SGW STAB MARKER .014 180 ST SS

    FDA Adverse Event
    Malfunction ·CORDIS CORPORATION·Product code DQX·May 25, 2011

    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 28, 2021

    REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014

    1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 26, 2022

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012