13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SMITH & NEPHEW INSTRUMENT TRAYS
FDA 510(k)
FDA Class 2
·General Hospital
Thermaloy
FDA UDI
Rmo, Inc.·00885797017888·THERMALOY(R) PREFORMED IDEAL ARCH MX .017 X .025
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
FDA 510(k)
FDA Class 2
·Cardiovascular
INFINION? CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 1, 2025
XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·April 23, 2013
RIATA ST OPTIM ACTIVE-FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 26, 2011
VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.
FDA Enforcement
Class II
·Terminated·DJO, LLC·July 10, 2013
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 PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022