16 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BASIC BREAST PUMP
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
FDA 510(k)
FDA Class 2
·Radiology
SURVEYOR CENTRAL STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
RECEPTAL CANISTER 1000 ML CE
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD.·Product code GCX·May 25, 2012
RECEPTAL 1.5LITER PE/CE WITH (50/CASE)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·August 1, 2011
NON-PVC RECEPT LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
NON-PVC RECEPT. LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
NON-PVC RECEPT LINER 2000ML/CE(50/CS)
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code GCX·June 21, 2011
RECEPTAL 1.5 LITER PE/CE WITH (50/CASE)
FDA Adverse Event
Injury
·HOSPIRA LTD.·Product code GCX·November 18, 2010
RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·June 24, 2011
RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code GCX·June 24, 2011
ELECTRIC PEN DRIVE 60,000 RPM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code HWE·May 27, 2014
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NEK·November 8, 2012
DELTEC COZMO INSULIN PUMP
FDA Adverse Event
Injury
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·September 7, 2010
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
FDA Enforcement
Class II
·Ongoing·Isopure Corp·July 20, 2022