15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
FDA 510(k)
FDA Class 2
·Neurology
ambIT* DISPOSABLE PLUS
FDA UDI
Avanos Medical, Inc.·00193494001988·ambIT* DISPOSABLE PLUS
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776418922·5mm33cm Insulated L Hook Electrode Side Mount R...
ELMED
FDA UDI
ELMED INCORPORATED·00842180107274·5 MM DIA., 33 CM INSULATED L-HOOK ELECTRODE, SI...
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00198506086793·5MM DIA., 28CM, MONOPOLAR LAPAROSCOPIC L-HOOK E...
ACCOLADE II HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
GC FUJI ORTHO BAND PASTE PAK
FDA 510(k)
FDA Class 2
·Dental
DPB1 SSP UNITRAY KIT
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORP·Product code MZI·May 24, 2013
DPB1 SSP UNITRAY 12 TESTS
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORP·Product code MZI·September 5, 2014
DPB1 SSP UNITRAY W/TAQ 12 TEST
FDA Adverse Event
Malfunction
·LIFE TECHNOLOGIES CORP·Product code MZI·September 5, 2014
BIOGLUE SURGICAL ADHESIVE
FDA Adverse Event
Other
·CRYOLIFE, INC.·Product code MFI·October 30, 2008
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 18, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France Intended for cementless application in total or hemiarthroplasty procedures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 18, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021