45 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONSTELLATION VISION SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517635495·CoRoent Ant TLIF PEEK, 10x11x28mm 15°
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690123811·Tri Cut Tip- Tri-Drive pin
Spine Wave Instruments
FDA UDI
Spine Wave, Inc.·10840642154542·Cup Curette, Size 2, 30 Degree, Right
Zavation
FDA UDI
Zavation LLC·00197157009946·8.5mm TAP, NAVLOCK
LITETOUCH MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCU-CHEK GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·July 9, 2020
ACCU-CHEK GUIDE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE, INC.·Product code NBW·July 9, 2020
AS VEGA PS TIBIAL PLATEAU CEMENTED T3
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code JWH·April 4, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
QUICH CHECK ONE
FDA Adverse Event
Injury
·DIAGNOSTIC SOLUTIONS, INC.·Product code CFR·December 26, 1996
QUADRA ASSURA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·September 6, 2011
AS COLUMBUS REV F FEMUR CEMENTED F5L
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code JWH·April 3, 2018
AS VEGA PS TIBIAL PLATEAU CEMENTED T3+
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code JWH·April 3, 2018
AS VEGA PS TIBIAL PLATEAU CEMENTED T2
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code JWH·April 3, 2018
AS COLUMBUS REV F TIB.OFFSET CEMENT.T5
FDA Adverse Event
Malfunction
·AESCULAP AG·Product code JWH·April 3, 2018