13 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
U2 ACETABULAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450198674·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450269060·
ENDOPATH VEIN HARVEST TRAY
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code GCJ·September 13, 1996
BOHN FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
FDA 510(k)
FDA Class 2
·Orthopedic
RD SET GE - 12
FDA Adverse Event
Malfunction
·Product code DQA·August 13, 2021
BD PREPSTAIN
FDA Adverse Event
Malfunction
·TRIPATH IMAGING, INC.·Product code MNM·April 5, 2013
VITALITY
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS·Product code LXB·May 22, 2008
Cadence Science Pressure Control Glass Syringe, Part Nos. 5338 (GTIN #816329023381); 5339 (GTIN #816329023398); 5340 (GTIN #816329023404); 5341 (GTIN #816329023411); 5342 (GTIN #816329023428); 5343 (GTIN #816329023435) - Product Usage: General Hospital Use
FDA Enforcement
Class II
·Terminated·Cadence Science, Inc.·November 20, 2019
Aurora Series, Aurora 7 lighthead; Models: LED7 (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
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012