101 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCARLET AC-T
FDA 510(k)
FDA Class 2
·Orthopedic
MOUNT-1B
FDA UDI
Aktormed GmbH·04260463840650·
External Fixation
FDA UDI
Life Spine, Inc.·00190837023621·Bayonet Wire
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2)
FDA 510(k)
FDA Class 2
·Radiology
D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·July 19, 2021
UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·April 29, 2021
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 12, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 3, 2025
LOCKING TITANIUM ADAPTER
FDA Adverse Event
Malfunction
·KANAE CO.,LTD.·Product code KDJ·June 17, 2013
RENAISSANCE 29 STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 20, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIC·Product code NIQ·September 23, 2008
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
ORTHOPEDIATRICS 130 DEGREE LOCKING CANNULATED INFANT BLADE 25MM X 0MM X 3-HOLE
FDA Adverse Event
Malfunction
·ORTHOPEDIATRICS, CORP·Product code HRS·February 10, 2018
UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·November 23, 2020
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·December 31, 2020
D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·August 27, 2020
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 20, 2024
TRI-TOME PC PROTECTOR
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 12, 2022
TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code KNS·November 18, 2021