66 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28
FDA 510(k)
FDA Class 2
·General Hospital
SimPro™ Kit
FDA UDI
Wellspect AB·07392532195259·Single Use Urinary Catheter with water sachet. ...
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641493·Semi-automatic Disposable Biopsy Needle
TAURUS
FDA UDI
CTL Medical Corporation·00841732150874·5.5mm Straight Rod 600mm Ti Alloy external hex
Taurus Pedicle Screw System
FDA UDI
SINTX Technologies, Inc.·M555252201600·Taurus Pedicle Screw System- Straight Rod Ext H...
iTotal CR
FDA UDI
Conformis, Inc.·M572RCR0201600031·ITOTAL CR–IPOLY XE–16MM MEDIAL INSERT KIT–LEFT ...
iTotal Identity CR
FDA UDI
Conformis, Inc.·M572RCR0201600041·ITOTAL IDENTITY CR TIBIAL INSERT + TRIAL, IPOLY...
iTotal Identity Posterior Stabilized Knee Replacement System
FDA UDI
Conformis, Inc.·M572RPS0201600031·ITOTAL IDENTITY PS TIBIAL INSERT + TRIAL, IPOLY...
iTotal Identity CR
FDA UDI
Conformis, Inc.·M572RCR0201600141·ITOTAL IDENTITY CR TIBIAL INSERT, NO TRIAL, IPO...
iTotal PS
FDA UDI
Conformis, Inc.·M572RPS0201600121·ITOTAL PS IPOLY XE - 16MM INSERT - LEFT or righ...
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641578·Semi-automatic Disposable Biopsy Needle
Battalion
FDA UDI
ALPHATEC SPINE, INC.·00811801039058·Endplate Scraper, 16mm, Offset
SureCore Semi-automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414641653·Semi-automatic Disposable Biopsy Needle
<GENX> CODA INCUBATOR CELLMATE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL
FDA 510(k)
FDA Class 2
·Cardiovascular
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376666143·12mm Core Endplate Trial, Rnd 16mm
Ascend
FDA UDI
ALPHATEC SPINE, INC.·00190376518084·CV VBR Endplate Trial, Rnd 16 mm
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 25, 2016
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 19, 2016
VITEK 2 XL BLUE MODULE COLORIMETERIC
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·August 31, 2016