15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MYSHELL
FDA 510(k)
FDA Class 2
·Cardiovascular
Leksell Stereotactic System
FDA UDI
Elekta Solutions AB·07340201503454·Ear Plug Holders - ATTACHMENT, EAR PLUG LEFT
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WRISTWATCH BLOOD PRESSURE MONITOR A46
FDA 510(k)
FDA Class 2
·Cardiovascular
TRILOGY O2
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·February 14, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·May 9, 2008
STERLING SL BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·April 6, 2011
DISPOSABLE FIRSTPASS SUTURE PASSER, SELF
FDA Adverse Event
Injury
·ARTHROCARE CORP.·Product code HWQ·May 12, 2020
DISP FIRSTPASS STR PASSR SELF
FDA Adverse Event
Injury
·ARTHROCARE CORP.·Product code HWQ·April 29, 2020
DISP FIRSTPASS STR PASSR SELF
FDA Adverse Event
Injury
·ARTHROCARE CORP.·Product code HWQ·April 29, 2020
LIFEWISE BLOOD PRESSURE MONITOR
FDA Adverse Event
Injury
·RADIOSHACK·Product code DXN·October 20, 2004
BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024