3,002 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Iontophoresis Electrodes
FDA 510(k)
FDA Class 2
·Physical Medicine
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788022912·20g RW x 2.0" Stealth™Coudé® Needle w/ 6" Exten...
MEGA PLUS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665580481·Rod(CoCr), Ø5.5 x 200mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694036764·FPS 2.0mm Screwdriver Sleeve
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247409·No-Profile Interbody, 39mm x 30mm x 20mm, 20 Deg
SPEEDLOCK
FDA UDI
Smith & Nephew, Inc.·00817470003406·HIPSLIDE SLOTTED CANNULA INSERTION GUIDE
N/A
FDA UDI
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.·00889024369504·FOOT SUPPORT EXTRA WIDE
51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW
FDA 510(k)
FDA Class 2
·Radiology
ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 1, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 17, 2013
VITEK¿ 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards per carton.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·June 21, 2017
VITEK 2 Gram Positive Susceptibility card (AST-P603), REF 22320, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·April 8, 2020
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·March 11, 2020
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code OZO·May 15, 2020
NUCLEUS CI632 PROFILE PLUS WITH SLIM MODIOLAR ELECTRODE
FDA Adverse Event
Injury
·COCHLEAR LTD·Product code MCM·November 22, 2020