16 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
Lode B.V.
FDA UDI
Lode B.V.·08717524640217·925901 Brachumera Sport
PORT ACCESS INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
INCISOR I PULSED ND:YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
STERILMED, INC.·10888551007580·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007573·SAW BLADE SAGITTAL FLARED K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007559·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007566·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007603·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007597·SAW BLADE SAGITTAL K9 K2000 SERIES
COULTER® LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·January 22, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
ALLURE QUADRA RF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 10, 2014
ABC HANDPIECE LAPAROSCOPIC
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 2, 2013
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
FDA Enforcement
Class II
·Terminated·Arjo Hospital Equipment AB·October 15, 2014