11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ATRIA 3100, ATRIA 6100
FDA 510(k)
FDA Class 2
·Cardiovascular
MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
FDA 510(k)
FDA Class 2
·Ophthalmic
VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ISA CO2
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022
ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 16, 2013
OLYMPUS
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·June 3, 2008
CONTAK RENEWAL TR
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NKE·April 15, 2011
TFNA FEM NAIL Ø10 R 125° L320 TIMO15
FDA Adverse Event
Injury
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HSB·February 7, 2018
10MM/125 DEG TI CANN TFNA 200MM - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 21, 2018
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology