12 results · 26ms · Sources: EU EUDAMED, US FDA

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BCG REAGENT SERUM ALBUMIN W/TECHNICON

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VITROS

FDA UDI
ORTHO CLINICAL DIAGNOSTICS·10758750002078·VITROS Immunodiagnostic Products NT-pro BNP Cal...

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM

Needle Holder

FDA UDI
KATENA PRODUCTS, INC.·00841668118368·Anis NdlHldr, Curved, W/Lock, X-Delicate

KETTOSIL AND SILGINAT

FDA 510(k)
FDA Class 2 ·Dental

RANGER II M6, MODEL IN-888WNL

FDA 510(k)
FDA Class 2 ·Physical Medicine

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 23, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 22, 2007

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

PROPONENT DR SL (Model L201)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

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