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

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Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)

FDA 510(k)
FDA Class 2 ·Radiology

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003103·270 micron Holmium Laser Fiber Cable, Single Us...

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003127·400 micron Holmium Laser Fiber Cable, Single Us...

OptoMonitor 3

FDA UDI
Opsens Inc·07540184013166·

AGXO

FDA UDI
Oticon A/S·05707131353191·G400 S, MINIRITE 312 2.4G C044 AGXO

LIPOSUCTION CANNULA

FDA UDI
SONTEC INSTRUMENTS, INC.·B0992013160·LIPOSUCTION CANNULA GRATER STYLE

Kirwan

FDA UDI
KIRWAN SURGICAL PRODUCTS LLC·00841019105122·Irrigating Bipolar Coagulation Forceps 7 1/8" (...

ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

UNiD IB3D ALIF

FDA 510(k)
FDA Class 2 ·Orthopedic

HAMILTON-C3

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·February 9, 2024

INSPIRE OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·March 4, 2026

INSPIRE OXYGENATOR

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTZ·November 20, 2025

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 27, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 26, 2013

IAB : 8 FR - 40 CC FOS

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC·Product code DSP·August 3, 2011

CHECK-IT

FDA Adverse Event
Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 23, 2022

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

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021