14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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van Andel Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486003753·MCK BASEPLATE TRIAL (SIZE 6 RM/LL)
n/a
FDA UDI
Ortho Development Corporation·00822409091751·Diamond Tooth Broaches Size 16
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973107521·TRIAL 90-SRK-170616 POLY UCCS 6X16MM
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO
FDA 510(k)
FDA Class 1
·Clinical Chemistry
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD SAFETYGLIDE¿ INSULIN SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE·Product code FMF·September 17, 2018
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·April 18, 2013
NC QUANTUM APEX PTCA DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 21, 2011
CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·September 16, 2008
TREVO XP PROVUE 4MM X 30MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020
BD¿ PRO SAFETY CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FOZ·June 25, 2018
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·April 19, 2023
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023