12 results
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28ms
·
Sources: EU EUDAMED, US FDA
STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510
FDA 510(k)
FDA Class 2
·General Hospital
PAQ.216X300X500.EEG.ATES
FDA UDI
AB MEDICA GROUP, S.A.·08428763010241·
Mediflex Modular III Basic Laparoscopic Instruments
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102104381·Modular 3 Spoon/Stone Forceps,Ratcheted Handle/...
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123076·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 75mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123823·K-WIRE - DOUBLE TROCAR 1.6mm DIA x 75mm
AGILIA INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
NIVEOUS LIQUID DAM
FDA 510(k)
FDA Class 1
·Dental
3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATE
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HRS·December 6, 2010
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·January 16, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 6, 2014
CONNECTOR, 1/4" X 1/4" STRAIGHT WITH LUER LOCK PORT
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code OEZ·April 26, 2016
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025