15 results
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22ms
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Sources: EU EUDAMED, US FDA
NSI CHLORIDE REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MGB Alert HSV1 Primer Mix, 48 rxn ASR, Finished Product
FDA UDI
Elitechgroup Mdx LLC·03661540952005·MGB Alert HSV-1 Primer Mix is an analyte specif...
MGB Alert HSV-1 Primer Mix ASR, 09N44-003
FDA UDI
Elitechgroup Mdx LLC·03661540950063·MGB Alert® HSV Typer AS Primer Mix contains che...
ACUMED
FDA UDI
Acumed LLC·10806378043215·MTP Reamer Radius Gauge 18-24mm
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
FDA 510(k)
FDA Class 2
·Cardiovascular
DESKTOP PRO
FDA 510(k)
FDA Class 2
·Radiology
1000 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·December 9, 2020
VENTED MICRO VOL.INLET, N/S
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022
250 ML TPN BAG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021
SYNERGY
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 8, 2014
PP DP PATIENT TUBING SINGLE
FDA Adverse Event
Injury
·BIOMET SPORTS MEDICINE·Product code HRX·October 22, 2012
M-1 COT - BASE HIGH LOAD 28
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV·Product code FPO·August 3, 2010
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
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