27 results · 23ms · Sources: EU EUDAMED, US FDA

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Dark Star Navigation Instrument System

FDA 510(k)
FDA Class 2 ·Neurology

MEGA5.5 SPINE SYSTEM

FDA UDI
BK MEDITECH CO.,LTD.·08809228125814·Rod, Ø5.5 x 280mm

Spex

FDA UDI
SPEX LIMITED·09420051700925·Spex 2 Point Padded Hip Belt, Centre Pull, Cent...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197537339·Hibbs Osteotom straight 28mm 240mm

SI-LOK SACROILIAC JOINT FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5

FDA 510(k)
FDA Unclassified ·Unknown

BD ALARIS PRIMARY PUMP INFUSION SET PVC

FDA Adverse Event
Malfunction ·BECTON DICKINSON·Product code FPA·January 22, 2026

DLP

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code DWF·December 3, 2025

BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·November 4, 2025

PICC-NATE 1.9 FR

FDA Adverse Event
Injury ·UTAH MEDICAL·Product code LJS·October 24, 2008

OXFORD UNICOMPARTMENTAL KNEE PHASE 3 FEMORAL SMALL

FDA Adverse Event
Injury ·BIOMET UK LTD·Product code NRA·August 15, 2011

DAILY ACTIVITY ASSIST DEVICES

FDA Adverse Event
Malfunction ·INVAMEX·Product code ILS·July 8, 2013

BD TEXIUM NEEDLE-FREE SYRINGE

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·November 3, 2025

JGRKNT 1.0MM MINI 3-0 NDLS

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code DZL·February 2, 2026

BD ALARIS SMARTSITE TEXIUM PUMP INFUSION SET

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·November 4, 2025

JUGGERSTITCH CURVED IMPLANT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code MBI·June 20, 2023

BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 16, 2020

Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B

FDA Enforcement
Class II ·Ongoing·Merit Medical Systems, Inc.·August 20, 2025

LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131

FDA Enforcement
Class II ·Ongoing·LSL Healthcare Inc.·April 29, 2026

GELPOINT® MINI ADVANCED ACCESS PLATFORM

FDA Adverse Event
Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·September 29, 2025