11 results · 19ms · Sources: EU EUDAMED, US FDA

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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