12 results · 22ms · Sources: EU EUDAMED, 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