14 results · 21ms · Sources: EU EUDAMED, US FDA

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HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780828·LEVAMED ACTIVE ANKLE SUP SLVR R IV

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0112340·Tap, 6.50mm, Fixed Sleeve

BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L

FDA 510(k)
FDA Class 2 ·Ophthalmic

BIOINSULATED SILICONE PUNCTUM PLUG

FDA 510(k)
FDA Unclassified ·Unknown

UNK

FDA Adverse Event
Injury ·ARTHREX, INC.·Product code GAT·March 2, 2026

INSIGNIA

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 8, 2013

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Malfunction ·CORDIS DE MEXICO·Product code NIQ·May 9, 2008

MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING·Product code LXH·April 6, 2011

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 2024

Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

FDA Enforcement
Class I ·Ongoing·Thoratec Corp.·May 8, 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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018