21 results
·
23ms
·
Sources: EU EUDAMED, US FDA
COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581
FDA 510(k)
FDA Class 2
·Hematology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257010105·M.3 SOFT OA BRACE, VARUS, RIGHT, LG
Pedo OnBrace Crown UL7 (5/pk)
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199014140·
Stainless Steel Connector
FDA UDI
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)·10381780033370·Connectors are implantable accessories intended...
Elite®Opti-MIM® Bondable Buccal Tubes
FDA UDI
Ortho Organizers, Inc.·00190707070243·.018 L6L STD OPTI-MIM -25T DB
TCP
FDA UDI
WRIGHT MEDICAL TECHNOLOGY, INC.·00840420118295·
VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH
FDA 510(k)
FDA Class 2
·Cardiovascular
KWIKKMODEL
FDA 510(k)
FDA Class 2
·Dental
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
VISI-PRO PTA BLLOON CATHETER
FDA Adverse Event
Injury
·EV3 INC.·Product code FGE·November 3, 2010
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 8, 2013
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·June 17, 2020
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·January 16, 2025
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024