13 results
·
25ms
·
Sources: EU EUDAMED, US FDA
TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
NuVasive
FDA UDI
Nuvasive, Inc.·00887517391704·Uni Inserter, CoRoent XL Dismantlable
PAQ.111X100X200.ORION
FDA UDI
AB MEDICA GROUP, S.A.·08428763008583·
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756395335·BRUNSWICK PACK
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756020008·FINGER SPLINT
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G5869111010·round caps, gas or steam permeable, can be used...
NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
Kendall NPWT Incision Management Dressing Kit
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MITEK MINILOK QUICHANCHOR PLUS W/ #2/0 ETHIBOND
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·July 25, 2008
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 11, 2013
PROFEMUR(R) MODULAR FEMORAL NECK
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·November 30, 2010
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 2, 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