35 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Scopis Extended Instrument Set EM
FDA 510(k)
FDA Class 2
·Neurology
ALPHAONE BIOFEEDBACK SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MYRAY HYPERION
FDA 510(k)
FDA Class 2
·Dental
AMISTEM-H PROXIMAL COATING STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 3, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 17, 2024
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 14, 2014
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·June 15, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011
CUP: MPACT ACETABULAR SHELL 54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·July 14, 2020
LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft tissue and bony defects.
FDA Enforcement
Class I
·Terminated·DePuy Orthopaedics, Inc.·February 27, 2013
NOVOSYN QUICK UNDY 2/0(3)70CM DSMP24MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·April 23, 2021
NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 5, 2021
NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021
NOVOSYN QUICK UNDY 3/0(2)70CM DS19(M)DDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021
NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021
NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 29, 2021
NOVOSYN QUICK UNDY 4/0(1,5)70CM DS19MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·March 23, 2021
NOVOSYN QUICK UNDY 4/0(1,5)45CM DS19MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 3, 2021
NOVOSYN QUICK UNDY 3/0(2)70CM HR17(M)DDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·November 17, 2020
NOVOSYN QUICK UNDY 3/0(2)45CM HS23(M)DDP
FDA Adverse Event
Injury
·B. BRAUN SURGICAL, S.A.·Product code GAM·July 13, 2020