13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ALAR Nasal Valve Stent
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OMNI Mod Hip
FDA UDI
Omni Life Science, Inc.·00841690102861·OMNI Modular Stem Size 8, 17.5mm
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100233·LIEBERMAN ASPIRATING SPECULUM V-WIRE
MaxFuse,VBR, 12 (D) x 14 (W) x 35 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468056322·12 (D) x 14 (W) x 35 (H)
CADENS (TM) COLON
FDA 510(k)
FDA Class 2
·Radiology
PENUMBRA ASPIRATION PUMP, MODEL 115V
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VICTORY XL DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC, CRMD·Product code DXY·January 13, 2014
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code OJX·June 7, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·July 6, 2011
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·October 4, 2024
PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·October 9, 2019
PEDICLE SCREW 6X45
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWP·July 5, 2019
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016