8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
HM-0970
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ophthalmic Hook
FDA UDI
KATENA PRODUCTS, INC.·00841668103333·AKER LENS PUSHER STRAIGHT
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
GEM-STIM TENS, MODELS GM3XY AND GM3AXY
FDA 510(k)
FDA Class 2
·Neurology
LEGEND FOOTED ATTACHMENT
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·December 20, 2010
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·January 29, 2013
PERMANENT METAL ON METAL HIP REPLACEMENT, RIGHT
FDA Adverse Event
Injury
·BIOMET·Product code KWA·July 11, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024