36 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GATIFLOXACIN, 5 UG, BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
PowerPICC Provena
FDA UDI
Bard Access Systems, Inc.·00801741152634·Catheter Placement Kit
TruLock
FDA UDI
Rmo, Inc.·00885797644930·TRULOCK Primer Activated Adhesive Kit (40 Capsule)
CATHETER INTRODUCER KIT, 10.7F
FDA UDI
Zoll Circulation, Inc.·00849111075435·An endovascular catheter having a heat exchange...
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS
FDA 510(k)
FDA Class 3
·Cardiovascular
VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VANGUARD PFR FEMORAL LT SM
FDA Adverse Event
Injury
·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 13, 2013
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 17, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 19, 2008
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
FDA Enforcement
Class II
·Terminated·Myolyn Inc.·August 24, 2022
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022
C0H11, KII DISSECTING BALLOON, OVL, 3/BX
FDA Adverse Event
Injury
·APPLIED MEDICAL RESOURCES·Product code GCJ·March 24, 2022