16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ZIP MIS INTERSPINOUS FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SSW CARBIDE
FDA UDI
Ss White Burs, Inc.·D6901407152·FG SL CARBIDE 701 - 5 PACK
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037313121·STANDARD TRIAL HUMERAL CUP 135/145° Ø40 +15
STA...
Humelock II Cemented Reversible Shoulder
FDA UDI
FX SOLUTIONS·03701037314159·STABILITY TRIAL HUMERAL CUP CUSTOM MADE 135/145...
Meduloc Intramedullary Fracture Fixation (IFF) System
FDA UDI
MEDULOC, LLC·00810184540434·Machined Wire Pusher (1.5)
Universal Abutment
FDA UDI
BICON, LLC·00813110020864·Universal Abutment UA4 SP 15° - 2.0mm Post
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INTERDRY SILVER
FDA 510(k)
FDA Class 1
·General Hospital
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 2, 2019
AIRVO2 HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 18, 2016
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 3, 2014
AUTOPLEX SYSTEM W/ VERTAPLEX W/O NEEDLES
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-PUERTO RICO·Product code JDZ·May 31, 2013
ALARIS PCA MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·June 15, 2011
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013