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

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REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Safco D1amond

FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063751866·Sterile Single Use Burs - ISO Code 863-014F

ANODYNE Plate System

FDA UDI
CORELINK LLC·M7252024015·ANODYNE CERVICAL SCREW - VARIABLE SELF TAPPING...

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193107233·HA PEEK EVOS Straight, ,15mmx10mmx 22mm , BICON...

Secure-Loop 15 mm

FDA UDI
XIROS LTD·05060267131423·

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710310240150·Talar Osteotmy Guide, 24mm x 15mm

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710810240150·Dwyer Calcaneal Guide, 24mm x 15mm

OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

BEAM BLOCK TRAYS

FDA 510(k)
FDA Class 2 ·Radiology

INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code MHY·March 10, 2022

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·March 7, 2019

INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code MHY·May 17, 2024

ENTERRA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·March 27, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·February 14, 2011

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP.

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 5, 2008

Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX

FDA Enforcement
Class I ·Ongoing·Baxter Healthcare Corporation·July 23, 2025

PROCLAIM 7 ELITE

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·September 13, 2018

PANEL PHOENIX NMIC/ID-307

FDA Adverse Event
Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·December 22, 2023

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