BEUDAMED
    23 results · 22ms · Sources: EU EUDAMED, US FDA

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    Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777457·LUMBAMED PLUS FLEX PAD WM SILVER III

    SOFTSILK CLEAR-TRAC

    FDA UDI
    Smith & Nephew, Inc.·00885554010701·SOFTSILK SCR 2.0 8X20 IN CANN LTX (1)

    Garrett Vessel Probe 21cm 1.5mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034047187·Garrett Vessel Probe 21cm 1.5mm

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319744482·Cottle Double Hook 5-7/8" (14.7cm), two sharp p...

    Dilator, Vascular, acc. Garrett 21cm 1.5mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034047231·Dilator, Vascular, acc. Garrett 21cm 1...

    Garrett Vascular Dilator 21cm 1.5mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034047224·Garrett Vascular Dilator 21cm 1.5mm

    HET BIPOLAR ELECTROCAUTERY FORCEPS

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

    ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMPLANT, ENDOSSEOUS, ROOT-FORM

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 28, 2025

    PERIPHERALLY INSERTED CENTRAL CATHETER

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS INC.·Product code LJS·February 12, 2015

    ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 20, 2008

    SENSOR, MMT-7002C, 10PK, GLUCOSE, BSA, 17L

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·August 3, 2011

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013

    CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)

    FDA Adverse Event
    Death ·CURRENT HEALTH LTD·Product code MSX·September 9, 2024

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·January 16, 2026

    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products, REF RX2300

    FDA Enforcement
    Class II ·Terminated·Anodyne Surgical·June 23, 2021

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; Used in spinal fixation surgery.

    FDA Enforcement
    Class II ·Terminated·Integrity Implants Inc.·December 14, 2022

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    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