14 results · 24ms · Sources: EU EUDAMED, US FDA

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SCIg60 Infusion System

FDA 510(k)
FDA Class 2 ·General Hospital

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776398767·Bruns Curette, 9", angled, oval, size 6

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183822·Integra® Jarit® Bruns Oval Cup Curette, Angled,...

Ballard* Multi-Access Port Closed Suction System

FDA UDI
Avanos Medical, Inc.·00609038200705·BALLARD* Multi-Access Port Catheter, Double Swi...

PRO-TOE HAMMERTOE FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

RESOLUTION HEMOSTASIS CLIPPING DEVICE

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

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·March 17, 2022

IMPLANT, ENDOSSEOUS, ROOT-FORM

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

K-WIRE

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·December 9, 2016

FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

INGENIO

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 22, 2013

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

FDA Enforcement
Class II ·Terminated·Halyard Health, Inc·April 25, 2018