13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REMEL
FDA UDI
REMEL, INC.·00848838005831·Andrades Broth w/1% Sucrose 20/PK
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306801488·Adson-Brown Forceps - 7 x 7 Teeth, 2.0 mm Tip, ...
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·October 2, 2013
HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·April 15, 2011
NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·April 16, 2013
PRESIDIO 18 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MICRUS ENDOVASCULAR, LLC·Product code HCG·September 4, 2014
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012