21 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPLIT CATH III
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TIBIAL, CHECKPOINT, STERILE
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OLO·November 3, 2016
NA
FDA UDI
MAKO SURGICAL CORP.·00848486001353·KNEE TIBIAL CHECKPOINT
Stryker
FDA UDI
Provision·B504OM1116510·
TIBIAL, CHECKPOINT, STERILE
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OLO·September 28, 2018
TIBIAL, CHECKPOINT, STERILE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·September 3, 2019
OsteoMed
FDA UDI
OSTEOMED LLC·00845694052450·1.6mm Extended Twist Drill, 5mm STOP, Hex Shank
Flexitron
FDA UDI
Nucletron B.V.·08717213026445·Flexitron Transfer Tube CT/MR for channel 1 (1)
TIBIAL, CHECKPOINT, STERILE
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OLO·December 5, 2016
TIBIAL, CHECKPOINT, STERILE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·December 23, 2019
TIBIAL, CHECKPOINT, STERILE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·January 31, 2020
TIBIAL, CHECKPOINT, STERILE
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OLO·August 22, 2016
4CH FLEX SPEEDER
FDA 510(k)
FDA Class 2
·Radiology
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Tandry Locking Plate System
FDA UDI
MICROWARE PRECISION CO., LTD.·04719873098064·2.4mm Locking Volar Distal Radius Plate, 5 Hole...
TIBIAL CHECKPOINT STERILE
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·February 18, 2026
E2 BREATHE ATOMIZER
FDA Adverse Event
Injury
·NEPHRON PHARMACEUTICALS CORP·Product code CCQ·May 13, 2013
PRECISE RX NITINOL STENT
FDA Adverse Event
Death
·CORDIS DE MEXICO·Product code NIM·August 11, 2008
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 2, 2011
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