14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ABBOTT AXSYM ANTI-THYROID-PEROXIDASE, MODELS5F57 COMPRISING STANDARDS/CALIBRATORS
FDA 510(k)
FDA Class 2
·Immunology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040115234·OBTURATOR - VER - SIZE 30 Verifier 6 Pack - SIV
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717103667·Midway Select Sutures 3-0 Black Braided Silk C3...
B-P TOTAL SHOULDER SYSTEM
FDA UDI
ENDOTEC, INC.·00814193025029·B-P SHOULDER GLENOID BEARING SIZE 3, 0 MM THICK...
Alteon
FDA UDI
Exactech, Inc.·10885862549327·
TANTALUM BEADS - RADIOGRAPHIC MARKER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COLORADO MICRODISSECTION NEEDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD INSTRUMENT MAX CLINICAL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code OOI·September 21, 2020
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 25, 2013
RADIESSE DERMAL FILLER
FDA Adverse Event
Other
·MERZ AESTHETICS, INC.·Product code LMH·March 11, 2011
6.2MM TI CLICK'X PEDICLE SCR PREASSEMBLED
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code MNH·March 27, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
iChem VELOCITY Urine Chemistry Analyzer
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·January 29, 2020