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

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V FACTOR DISCS

FDA 510(k)
FDA Class 1 ·Microbiology

EasyTouch

FDA UDI
MHC MEDICAL PRODUCTS, LLC·MHC18025011·

36M - City of Gastonia - Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588025018·36M - City of Gastonia - Metal

FacetLINK MI

FDA UDI
LINKSPINE, INC.·00817329024460·Dilator 1

Innomed, Inc.

FDA UDI
INNOMED, INC.·00840277114372·Nordt Micro Fracture 20 Degree Awl

Quantib Prostate

FDA 510(k)
FDA Class 2 ·Radiology

PFIZER/AS&E 0450 LOCALIZER

FDA 510(k)
FDA Class 2 ·Orthopedic

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·May 9, 2014

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FDA Adverse Event
Malfunction ·KARL STORZ ENDOSCOPY·Product code FED·September 24, 2012

ANTI-REFLEC Y-SET 8"

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code ---·August 17, 2010

Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.

FDA Enforcement
Class II ·Ongoing·Philips North America·May 6, 2026

SmartPath to dStream for 1.5T

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·November 29, 2023

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

PROPONENT DR SL (Model L201)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 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