44 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CENTRAL MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Bur PM2-70 80K Steel Ø3.1 St
FDA UDI
Bien-Air Surgery SA·17630055503241·
Bur PM2-70 80K steel Ø3.1mm sterile
FDA UDI
Bien-Air Surgery SA·J00711003580011·
AuraGen Aesthetics
FDA UDI
Auragen Aesthetics LLC·00860003492703·AuraGen 1-2-3 with AuraClens - Lipoaspirate Was...
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707045487·STAINLESS STEEL COAXIAL ARCHWIRE .015 (30' SPOOL)
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450241677·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450174586·
Tether™
FDA UDI
Seaspine Orthopedics Corporation·10889981035631·Plate - 3 Level - 58mm
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
BAXANO IO-FLEX SYSTEM
FDA Adverse Event
Other
·BAXANO, INC.·Product code HAE·July 2, 2012
QUANTA SYSTEM S.P.A.
FDA Adverse Event
Malfunction
·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012
MULTI ADJUSTABLE FACE MASK
FDA 510(k)
FDA Class 2
·Dental
VIGIL SEROLOGY CONTROL LEVEL C
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 30, 2024
EYE SURGERY STRETCHER OBS 3/07
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 8, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 18, 2014
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 13, 2011
PROG VALVE INLINE W SG
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·September 22, 2021
Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012