14 results · 19ms · Sources: EU EUDAMED, US FDA

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HEMOGLOBIN CONTROL LEVELS

FDA 510(k)
FDA Class 2 ·Hematology

Precept

FDA UDI
Nuvasive, Inc.·00887517351616·PRECEPT NIT K-Wire, Threaded Tip Long

GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS

FDA 510(k)
FDA Class 2 ·Cardiovascular

SONIC AIR MM1500 + (MID), MODEL 50400014

FDA 510(k)
FDA Class 2 ·Dental

CURRENT DR RF

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·May 8, 2014

DEPUY ASR XL FEM IMP SIZE 51

FDA Adverse Event
Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·October 23, 2012

ASR UNI FEMORAL IMPL SIZE 43

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 11, 2010

ClearView Uterine Manipulator with disposable Sound-Dilator (DSD-1000), REF UM210, 7 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.

FDA Recall
Terminated ·Clinical Innovations, LLC·Product code LKF·May 12, 2008

ClearView Uterine Manipulator, Long tip version with disposable Sound-Dilator (DSD-1000), REF CV2000, 9 cm, Sterile, Clinical Innovations, 747 West 4170 South, Murray, Utah 84123.

FDA Recall
Terminated ·Clinical Innovations, LLC·Product code LKF·May 12, 2008

Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025

FDA Recall
Terminated ·Clinical Innovations, LLC·Product code NQM·August 13, 2020

Philips Zenition 50, Model Number: 718096

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024