16 results · 19ms · Sources: EU EUDAMED, 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