BEUDAMED
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    Synergy Gold (SG) Portable (Models MM011450 and MM011460)

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

    SKYN

    FDA UDI
    Lil' Drug Store Products, Inc.·00792554902021·SKYN Elite Large Non-Latex Condom, 3ct

    DG Gel 8 Anti-e

    FDA UDI
    DIAGNOSTIC GRIFOLS SA·08437014205145·For the determination of human e antigen on the...

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010101891·GIGLI SAW HANDLES PAIR

    Dilator, Vascular, acc. Garrett 19cm 2.0mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034046906·Dilator, Vascular, acc. Garrett 19cm 2...

    Dilator, Vascular, acc. Garrett 19cm 2.0mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034046913·Dilator, Vascular, acc. Garrett 19cm 2...

    FETAL DOPPLER JPD-100S

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

    ARTHREX UNIVERS 30 SHOULDER PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·January 28, 2026

    PALINDROME HSI KIT 23/40 CM X5

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MSD·June 27, 2013

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FPO·October 20, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 12, 2011

    THORACIC PROBE TIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code OLO·June 20, 2025

    AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14

    FDA Enforcement
    Class II ·Terminated·Avid Medical, Inc.·March 7, 2018

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-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 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 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