12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
FDA 510(k)
FDA Class 2
·Orthopedic
Modulus Expandable
FDA UDI
Nuvasive, Inc.·00195377055910·MOD-EX PL Trial, 7x11mm
DRIVEMEDICAL
FDA UDI
Drive Devilbiss Healthcare·50050428498892·Canes & CrutchesOffset Product Description: OFF...
Life Instruments
FDA UDI
Life Instrument Corporation·M93079807111A0·Atraumatic Suction Tube 11FR 6" from bend
Life Instruments
FDA UDI
Life Instrument Corporation·M930798071110·Stainless Frazier Suction 11FR 6" from bend
Life Instruments
FDA UDI
Life Instrument Corporation·M9307980711110·Frazier Suction Tube 11FR, 7" OL, 6" from bend
FUJIFILM Endoscopic CO2 Regulator GW-100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
FDA 510(k)
FDA Class 2
·Radiology
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·February 27, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·February 7, 2011
PROXIMATE ILS STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 5, 2014
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·September 3, 2025