BEUDAMED
    17 results · 27ms · 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 ×

    MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N.A.

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR30710111·Set for uprighting spring with cross tube .018"

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193100036·EVOS Curved HA PEEK 11mm x 10mm x 30 mm,Biconve...

    General Instrument

    FDA UDI
    ORTHOPEDIATRICS CORP.·00841132127131·Large Self-Holding Screw Forceps

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0110110·Sounder, Ball Tip, Straight, Firm, Titanium

    LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIVESURE MORPHINE SCREEN TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 27, 2017

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·June 30, 2015

    HOSPITAL FULL FACE MASK WITH EXHALATION VENTS

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code MNT·March 3, 2008

    RAPIDPOINT 1265

    FDA Adverse Event
    Other ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code CHL·April 11, 2013

    TRIDENT PSL HA SOLID BACK 56MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·April 20, 2011

    POLROX PX 45 JBP

    FDA Adverse Event
    Malfunction ·BIOTRONIK GMBH AND CO.,·Product code DTB·July 2, 2008

    LEGION PS OXIN FEM SZ5 LT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018

    GII OVAL RESURFACING PAT 32MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015

    BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001417;

    FDA Enforcement
    Class II ·Ongoing·Beaver Visitec International, Inc.·September 4, 2024

    Medical convenience kits Item Number/Description ANSH14AF SHOULDER PACK - 205962 EVAH76H ANTERIOR HIP PACK FDSA15M SHOULDER ARTHROSCOPY GRTS90G TOTAL SHPULDER PACK HGHI26G HIP PINNING PACK HJTO25C TOTAL HIP ACCESSORY PACK HNEX60L EXTREMITY PACK IAHD53C HAND PACK IASH65A SHOULDER PACK IHUE40AI UPPER EXTREMITY PK| STRL F G ILTJ47AA TOTAL JOINT PACK LMHP14Z ORIF HIP, ST LUKES METHODIS LMSN44AE SPINAL PACK MHHP25H HAND PACK - 206002 MHTH90AJ TOTAL HIP PACK - 206016 MWAH32P ANTERIOR HIP PACK MWTK13AH TOTAL KNEE PLOR89H ORTHO MINOR PACK RCUE81B UPPER EXTREMITY RCH 0247031 TSTH54D TOTAL HIP TRAY UDEX85Y DSC EXTREMITY - 206050 UDHD69U HAND PACK - 206055 UDKN68AH CUSTOM KNEE - 206061 UIHN18AW ACS HAND PACK (PS 020640) UIHN18AX ACS HAND PACK (PS 020640) UIKN28AR ASC KNEE PACK (PS 020641) UISO44I SFCH SMALL ORTHO PACK (PS 143213)

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc.·October 22, 2025