BEUDAMED
    18 results · 21ms · 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 ×

    Kerecis Silicone

    FDA 510(k)
    FDA Unclassified ·Unknown

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777488·LUMBAMED PLUS FLEX PAD M SILVER I

    Data-Cyte Plus 3%

    FDA UDI
    Medion Grifols Diagnostics AG·07640137341749·Reagent Red Blood Cells panel used for identifi...

    OC-Auto

    FDA UDI
    POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917021423·Personal Use Kit OC-Auto, for Seattle, WA

    WARP10,WARP75

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TOTALCARE BARIATRIC

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 3, 2014

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

    LINEAR? ST

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 25, 2025

    CLIN CHEM LDH

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CFJ·February 12, 2018

    JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900

    FDA Enforcement
    Class II ·Ongoing·North American Rescue LLC.·October 8, 2025

    BD CONNECTA STOPCOCK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·June 2, 2020

    ALIYA

    FDA Adverse Event
    Injury ·NEAUVIA NORTH AMERICA, INC·Product code GEX·May 5, 2026

    MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan·Product code NGY·October 27, 2020

    MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S

    FDA Recall
    Terminated ·Mani, Inc. Kiyohara Facility Park 8-3 Kiyoharakogyodanchi; Kiyoharakogyodanchi; Kiyoharakogyodanchi Utsunomiya Japan·Product code NGY·October 27, 2020

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017