43 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VACUETTE EDTA K2 TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA
FDA Adverse Event
Malfunction
·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00141041·
BOTANIQ
FDA UDI
Inspecs U.S.A., L.C.·00841543148695·SUNGLASS
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0140040·Driver Shaft, T30 Split Tip Double End Cap Starter
OSTEOBELL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CANDELA LONG PULSE ND:YAG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 7, 2026
HEARTSINE SAMARITAN 300P AND PAD-PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·April 11, 2018
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
ANTHEM RF
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS
FDA Adverse Event
Other
·EDWARDS LIFESCIENCES·Product code LWR·March 12, 2008
O-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implants
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 24, 2016
HEARTSINE SAMARITAN 300P AND PAD-PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·May 13, 2019
HEARTSINE SAMARITAN 300P AND PAD-PAKV
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·June 17, 2019
HEARTSINE SAMARITAN 300P AND PAD-PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·June 13, 2019
HEARTSINE SAMARITAN 300P AND PAD-PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·May 17, 2019
PACKAGE,350P,PP01,EN,350-BAS-US-10
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·January 14, 2019
HEARTSINE SAMARITAN 300P AND PAD-PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·November 8, 2019
HEARTSINE SAMARITAN 300P AND PAD-PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·October 24, 2018