28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aesculap Optilene Nonabsorbable Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025
OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025
BI-METRIC X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304182707·
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304479364·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239656·
BI-METRIC X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304183001·
BI-METRIC X-SERIES HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304182400·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197080668·HALSEY needle holder, straight
13.0 c...
SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
FDA 510(k)
FDA Class 2
·Immunology
MOBILELINK ACETABULAR CUP SYSTEM
FDA Adverse Event
Malfunction
·WALDEMAR LINK GMBH & CO. KG·Product code LPH·February 20, 2025
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·October 15, 2014
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·July 27, 2011
CEMENT, BONE, VERTEBROPLASTY
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NDN·June 20, 2013
PFNA-II BLADE L85 TAN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HSB·December 22, 2015
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 5, 2021
Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·June 15, 2022
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·February 2, 2022