12 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Q2 Intravenous Adminstration Sets and Extension Sets
FDA 510(k)
FDA Class 2
·General Hospital
AGC TRADITION KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304240957·
AGXO
FDA UDI
Oticon A/S·05707131284396·H110V2 TI, BTE 13 WL 85 TC AGXO
ELMED
FDA UDI
ELMED INCORPORATED·00842180183100·TEBBETTS AUFRICHT RETRACTOR, WITH STABILIZATION...
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100240·SILICONE TUBING FOR ASPIRATING SPECULUM
SYNGO.VIA WEB VIEWER
FDA 510(k)
FDA Class 2
·Radiology
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
FDA 510(k)
FDA Class 2
·General Hospital
CONTAK RENEWAL TR
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NKE·July 6, 2011
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 6, 2013
CAD II
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 8, 2014
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·March 26, 2014
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014