9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CONDOM (RUBBER LATEX) OKEIDO
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
APSARA ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAMPYLOBACTER CVA AGAR
FDA 510(k)
FDA Class 1
·Microbiology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·July 2, 2015
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·June 25, 2014
PULSAR MAX
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code NVZ·November 10, 2008
6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·July 1, 2016
Stryker SmartPump Extension Tubing (Pneumatic tourniquet). Sterile tubing extension 40" and 60", set, luer lock. Rx only. Stryker Instruments Div. of Stryker Corporation. Optional accessories used with the Stryker SmartPump Tourniquet System. The luer locks are intended to be connected to the tourniquet pump - to fill the line - and to the cuff. The extension tubing is an optional accessory used to connect the tourniquet cuff with the pump when a longer distance between the pump and the tourniquet is desired. The extension tubing comes packaged 10 per box.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code KCY·August 25, 2011
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020