75 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CLEARBLUE EASY PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
Smith & Nephew, Inc.·03596010035608·LAMBOTTE OSTEOTOME STRAIGHT 19.0MM
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·50885380030503·3/5cc Secure Tall Cap
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306816369·Balfour 3.5in Wire Side Blades, Pair/2
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L11043310K0·Drill
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L11043315K0·Drill
UniTip Catheter
FDA UDI
Unisensor AG·07640172971307·
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306816376·Balfour 5in Wire Side Blades, Pair/2
DEPUY ATTUNE KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
FDA 510(k)
FDA Class 2
·Microbiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·September 16, 2014
GO BED PLUS
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·April 25, 2011
INSPIRE 6F
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·October 28, 2025
RESERVOIR INSPIRE 8
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·May 8, 2026
ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.
FDA Adverse Event
Injury
·AESCULAP AG·Product code NKB·December 21, 2018
ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.
FDA Adverse Event
Injury
·AESCULAP AG·Product code NKB·December 21, 2018
INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA·Product code DTZ·December 18, 2025
INSPIRE HARD VENOUS RESERVOIR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·July 25, 2022
INSPIRE HVR HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
FDA Adverse Event
Injury
·SORIN GROUP ITALIA SRL·Product code DTZ·January 13, 2023