23 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLEX Elite 9000 SS-OCT
FDA 510(k)
FDA Class 2
·Ophthalmic
Symmetry Dandy
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482046012·Symmetry® Forceps, Dandy Scalp, Curved To Side,...
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962111475·DANDY SCALP FORCEPS, 5 5/8", 1X2 TEETH, CVD SID...
GM HELIX ACQUA IMPLANT,TI,5.0X16
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·May 16, 2018
NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010
FDA 510(k)
FDA Class 2
·General Hospital
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
FDA 510(k)
FDA Class 2
·General Hospital
GM HELIX IMPLANT 4.3X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 6, 2018
GM HELIX IMPLANT 4.3X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 22, 2018
GM DRIVE ACQUA IMPLANT 3.5X8 MM
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·August 29, 2018
GM HELIX ACQUA IMPLANT 3.75X11.5
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018
GM HELIX IMPLANT 3.5X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·June 29, 2018
GM HELIX ACQUA IMPLANT 3.5X11.5
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 24, 2018
GM DRIVE IMPLANT 3.5X10
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·April 20, 2018
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 13, 2011
OPTIFLEX III PKG
FDA Adverse Event
Injury
·CHATTANOOGA GROUP·Product code BXB·September 15, 2008
METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·August 30, 2018
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code MPB·September 6, 2017
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017
Azurion 5 M12; System Code: (1)722227, (2)722231;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026