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