11 results · 17ms · Sources: EU EUDAMED, US FDA

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PULSED SELECTRON

FDA 510(k)
FDA Class 2 ·Radiology

ERA 3.25MM IMP 0DEG MICRO HEAD 15X4MM ACID ETCH, Ti

FDA UDI
STERNGOLD DENTAL LLC·00841549109829·Designed for both transitional and long-term de...

Seiva

FDA UDI
SUNTECH MEDICAL, INC.·10840935109990·

FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TCD 100M, PWD13 TRANSDUCER

FDA 510(k)
FDA Class 2 ·Radiology

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 30, 2014

ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

FDA Adverse Event
Injury ·ANIMAS CORP.·Product code LZG·November 12, 2010

RIATA ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·November 12, 2025

UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

FDA Enforcement
Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 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