BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Quadra-P

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ion Coagulation Pen

    FDA UDI
    ION MEDICAL, INC.·B9122027302·27 Gauge Fine Point Bipolar Coagulation Pen

    NA

    FDA UDI
    Synthes GmbH·10886982144638·3.0MM CANNULATED SCREW LONG THREAD/30MM

    JMS A.V. FISTULA NEEDLE SET

    FDA UDI
    JMS SINGAPORE PTE LTD·08888483005857·A.V.FISTULA 17GX1" 30CM W/CLAMP (TWIN)

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111179099·M.G.H. NEEDLE HOLDER 7"

    Diamond Orthopedic, LLC

    FDA UDI
    DIAMOND ORTHOPEDIC, LLC·B551DMD2027300·3.0mm, Cannulated Screw, Long Thd., 30mm

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF2027300·3.0mm Cannulated Screw, Long Thread, 30mm

    PERFADEX SOLUTION FOR LUNG PRESERVATION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    pjur WOMAN Nude pjur med SENSITIVE glide

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BD ULTRA-FINE PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·July 9, 2021

    5202730-2027S1B SER 1 SMOKE EVAC

    FDA Adverse Event
    Malfunction ·DAVOL SURGICAL INNOVATIONS (JUAREZ/MX)·Product code GCJ·April 24, 2003

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 17, 2008

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    RSP

    FDA Adverse Event
    Injury ·ENCORE MEDICAL L.P·Product code PHX·August 30, 2022

    ETHICON

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAL·April 10, 2026

    TERUMO SURFLO INTRAVENOUS CATHETER

    FDA Adverse Event
    Malfunction ·TERUMO PHILIPPINES CORPORATION·Product code FOZ·May 20, 2025

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015