11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Capillus 272 Office Pro
FDA 510(k)
FDA Class 2
·Physical Medicine
ECG Module(AHA)
FDA UDI
SAMSUNG MEDISON CO., LTD.·08806167712532·
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028383·PESSARY, GELLHORN #0, 1.50"
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
FDA 510(k)
FDA Class 2
·Cardiovascular
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·June 6, 2013
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MHY·June 22, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
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