16 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NICORE MODEL NCP-1 EXTERNAL COUNTERPULSATION DEVICE
FDA 510(k)
FDA Class 2
·Cardiovascular
n/a
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50230161·Rotary instrument für surgical application
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193100326·EVOS Straight HA PEEK 16mm x 9mm x 26mm Biconve...
APEX 3D Total Ankle Replacement System
FDA UDI
Paragon 28, Inc.·00889795153302·APEX 3D-PS Total Ankle Replacement System, 3.0 ...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710810230160·Dwyer Calcaneal Guide, 23mm x 16mm
EndoVive
FDA UDI
XERIDIEM MEDICAL DEVICES, INC.·00813939020021·
PRO-FEMUR R
FDA 510(k)
FDA Class 2
·Orthopedic
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·February 25, 2016
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 27, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
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 Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018