12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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METATARSAL DECOMPRESSION IMPLANT, MODEL 100
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776363949·Oringer Lip Retractor
LumaFlex Double J stent, 2 open tips, Ch/Fr4,8/L.28cm, without wire
FDA UDI
Promepla·03700512967484·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197194556·Ferreira Style Breast Retractor
90X27m...
NOOSA Anterior Lumbar Plate
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215019723·
W & H ASSISTINA
FDA 510(k)
FDA Class 1
·Dental
KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10
FDA 510(k)
FDA Class 2
·Ophthalmic
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014
FITMORE HIP STEM B, SIZE 4
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·May 6, 2011
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·May 8, 2013
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·August 8, 2012