13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TARGETSCAN BIOPSY KIT
FDA 510(k)
FDA Class 2
·Radiology
O-RING PROSTHETIC ATTACHMENT
FDA 510(k)
FDA Class 2
·Dental
ILT ADVANCING MECHANISM, MODEL A115AMI
FDA 510(k)
FDA Class 2
·Cardiovascular
NV GXL LNR, +5LAT, 36MM G3-56/58MM CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·April 15, 2024
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021
CE INFUSOR LV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE·Product code KDJ·April 8, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 10, 2011
FLEXTEND IS-1 BI POSITIVE FIX 45CM
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
CE INFUSOR SV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2010
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·February 28, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018