13 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DOWNS ADJUSTABLE FLOW GENERATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78315031·Micro Sprint Bracket Roth .018" mand. 4 left
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78315030101·Micro Sprint Bracket Roth .018" mand. 4 left
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78315030051·Micro Sprint Bracket Roth .018" mand. 4 left
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78315031001·Micro Sprint Bracket Roth .018" mand. 4 left
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0315030·Probe, 1.5 inch Ball, Steffee, Curved, Impaction
GN Otometrics A/S
FDA UDI
NATUS MANUFACTURING LIMITED·05713315003523·Silicone Eartip, 6mm semi gray, tree tip
AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
SE-601 SERIES ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 25, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 14, 2012
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2015
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