16 results · 26ms · Sources: EU EUDAMED, US FDA

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CRANIAL PERFORATOR

FDA 510(k)
FDA Class 2 ·Neurology

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450182086·

THE 5.0 X 6.0MM DENTAL IMPLANT

FDA 510(k)
FDA Class 2 ·Dental

BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME

FDA 510(k)
FDA Class 1 ·Ophthalmic

SIEMENS 1.5T TXRX 15 CH KNEE

FDA Adverse Event
Other ·QUALITY ELECTRODYNAMICS·Product code MOS·October 5, 2011

IMPL TAPERED SP 3.7MM 12M M OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

IMPL TAPERED SP 3.7MM 12M M OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·June 12, 2024

IMPL TAPERED SP 4.8MM 8MM OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 10, 2024

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 27, 2011

MCX CATHETER, CORONARY, ATHERECTOMY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code MCX·July 23, 2008

IMPL TAPERED SP 3.7MM 10M M OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·July 27, 2023

IMPL TAPERED SP 4.8MM 8MM OCTAGON

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·March 3, 2023

VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAM·April 7, 2025

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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