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

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INFUSA T SYRINGE INFUSION PUMP

FDA 510(k)
FDA Class 2 ·General Hospital

Stern Snap Abutment Base 5.5mm (A)

FDA UDI
STERNGOLD DENTAL LLC·00841549114182·Intended for use with dental implants to suppor...

ZIMMON ENDOSCOPIC PANCREATIC STENT

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

INVOTEC POLY-MESH MANDIBULAR TRAY

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

GEENEN PANCREATIC STENT SET

FDA Adverse Event
Injury ·COOK IRELAND LTD·Product code FGE·January 10, 2019

COLLEAGUE CXE VOLUMETRICINFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·November 22, 2010

FLOGARD

FDA Adverse Event
Malfunction ·SHARP CORPORATION OSAKA JAPAN·Product code FRN·January 9, 2013

ALTRX +4 NEUT 32IDX48OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 1, 2014

GEENEN PANCREATIC STENT

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

GEENEN PANCREATIC STENT

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

GEENEN PANCREATIC STENT

FDA Adverse Event
Injury ·COOK ENDOSCOPY·Product code FGE·September 14, 2018

UNKNOWN

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·June 9, 2021

ZIMMON PANCREATIC STENT

FDA Adverse Event
Malfunction ·COOK IRELAND LTD·Product code FGE·October 16, 2020

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 126 IN.; Catalog Number: 490488. 2. IV ADMIN SET W/15 DROPS/ML, 132 IN.; Catalog Number: 490492. 3. IV ADMIN SET W/15 DROPS/ML, 139 IN.; Catalog Number: 490503.

FDA Enforcement
Class II ·Ongoing·B Braun Medical Inc·December 3, 2025

IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 126 IN.; Catalog Number: 490488. 2. IV ADMIN SET W/15 DROPS/ML, 132 IN.; Catalog Number: 490492. 3. IV ADMIN SET W/15 DROPS/ML, 139 IN.; Catalog Number: 490503.

FDA Recall
Open, Classified ·B Braun Medical Inc·Product code FPA·October 29, 2025