21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
Smith & Nephew, Inc.·03596010038968·HOKE OSTEOTOME 3.2MM X 127MM
JOBST Anti-Em
FDA UDI
BSN MEDICAL, INC.·00035664114510·ANTI EM TH SR W 6 EN FR ES
P&P needle guide
FDA UDI
Noras MRI products GmbH·04251269201783·
MAXCUT CARBIDE BUR (10/pk) FGSS 35
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114511·MAXCUT CARBIDE BUR (10/pk) Shape: Inverted Cone...
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213032798·Coupling Treatment Tube for Metal Needles (11)
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089448821·
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
REUNITE FUSION SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·June 9, 2022
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Death
·CORDIS LLC (PR)·Product code NIQ·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
DURALOC CONST LINER 60/72X28
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 13, 2011
BD INTIMA-II¿ Y 22GAX1.00IN CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·December 28, 2021
BD INTIMA-II¿ PRN Y ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·October 25, 2022
BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·December 9, 2021
BD INTIMA II¿ IV CATHETER PRN ADAPTER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·February 2, 2022
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021