14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR20515401·Titanol S Spee-arches mand. .016"x.016"
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180500910·STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 12MM
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180500941·STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 18MM
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180500934·STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 16MM
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180500927·STIRRUP SCRAPER, UP-ANGLED DOUBLE SIDE - 14MM
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
FDA 510(k)
FDA Class 2
·Cardiovascular
RUSCH EDGAR TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
GMK-REVISION 3DMETAL FEMORAL CONE SMALL TRIAL
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LXH·July 30, 2020
CONCERTO
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·April 10, 2013
4F SINGLE PICC
FDA Adverse Event
Malfunction
·MEDCOMP·Product code LJS·May 16, 2008
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NIK·April 12, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024