11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ECAT SCANNER
FDA 510(k)
FDA Class 2
·Radiology
Cascade
FDA UDI
Musculoskeletal Transplant Foundation, Inc.·00859070006043·Autologous Platelet System-PRFM x 2
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756978316·CRANIOTOMY PACK
CERSR ELECTROMYOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 31, 2019
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·February 25, 2014
CONSTELLATION WITH LASER
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·November 10, 2010
HUDSON ISIS SUBCLOTTIC ENDOTRACHEAL TUBE, 6.0
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BTR·November 9, 2012
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 29, 2017
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·November 24, 2021