11 results · 26ms · Sources: EU EUDAMED, US FDA

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UltiCare Disposable Pen Needles

FDA 510(k)
FDA Class 2 ·General Hospital

Richard-Allan® Needle Straight Cutting

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00840113219094·Intent to be used with suture material for tiss...

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·October 29, 2019

SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS

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

AT HOME DRUG TEST, MODEL 9084

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 25, 2014

PINNACLE MTL INS NEUT36IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·August 12, 2011

AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - ANTERIOR

FDA Adverse Event
Injury ·C.R. BARD, INC. (COVINGTON)·Product code FTL·July 3, 2013

I-STAT CHEM8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 16, 2022

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

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

Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025