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