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

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EXAJET

FDA 510(k)
FDA Class 2 ·Dental

Lithotripsy Probe 1.9FR 375cm

FDA UDI
NORTHGATE TECHNOLOGIES INC.·00817183020066·1.9FR 375cm Lithotripsy Probe for use with Auto...

BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·June 21, 2019

HYALURONIDASE REAGENT, MODEL CAT#2212

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

HANDHELD GAMMA FINDER (HGF)

FDA 510(k)
FDA Class 1 ·Radiology

EZTETIC DENTAL IMPLANT, 3.1MM DIAMETER, 2.9MMD PLATFORM, 10MM LENGTH

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·December 22, 2020

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 28, 2025

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·April 8, 2025

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·June 4, 2025

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·July 8, 2024

CELL-DYN RUBY ANALYZER

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·March 27, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·March 18, 2011

VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT DPT

FDA Adverse Event
Other ·EDWARDS LIFESCIENCES·Product code DYG·March 24, 2008

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 Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

FDA Enforcement
Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

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