BEUDAMED
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    Agile Devices Angler Steerable, Deflectable Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551111351·HALO, 1203-5 VEST SMALL, ACRYLIC LINER, 1211-1 ...

    MATIRA ANTERIOR CERVICAL SYSTEM

    FDA UDI
    Kalitec Direct LLC·B07307K0111101·AWL, 10MM SPRING LOADED

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C41432111100·Titanium TLIF Spacer, 32 x 11 x 11mm, 0 deg

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C40432111100·PEEK TLIF Spacer, 32 x 11 x 11mm, 0 deg

    InterPulse

    FDA UDI
    STRYKER CORPORATION·04546540144348·Rechargable Handpiece Set with Bone Cleaning Ti...

    APNEA GUARD

    FDA 510(k)
    FDA Class 2 ·Dental

    M2A ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·October 23, 2008

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·August 5, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 8, 2013

    M2A ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 23, 2018

    Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 25 mm, P/N 7211110, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810

    FDA Recall
    Terminated ·Smith & Nephew, Inc. Endoscopy Division·Product code HWC·August 21, 2007

    LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC; DISC XS ULNA POR; DISC SEG ULNA POR; and Custom devices Item Nos. 114754 114755 114744 114745 114704 114705 114756 114757 114714 114715 114746 114747 114706 114707 114758 114759 114716 114717 114748 114749 114708 114709 114718 114719 CP561429 CP561430 CP561431 CP561432 CP561442 CP561449 CP561488 CP561489 CP561709 CP561710 CP561714 CP561715 PM555203 Product Usage: Total Elbow Replacement

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    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