102 results
·
20ms
·
Sources: EU EUDAMED, US FDA
STA-SET I.V. FLOW REGULATOR
FDA 510(k)
FDA Class 2
·General Hospital
Cross-Linked PE Insert
FDA UDI
ADLER ORTHO SPA·08050507130313·Cross-Linked PE Insert 15° Lipped Diam. 36 Gr. C
Trimline
FDA UDI
ORMCO CORPORATION·00889989052107·LOWER RIGHT SECOND MOLAR TRIMLINE BAND SIZE 6
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690199946·Steinman Pin No-Drive (152mm), Non Sterile
Arthrex®
FDA UDI
ARTHREX, INC.·00888867385665·Countersink, 2.0mm
AmCAD-UT Detection 2.2
FDA 510(k)
FDA Class 2
·Radiology
AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NexGen®
FDA UDI
Zimmer, Inc.·00889024199071·
NexGen®
FDA UDI
Zimmer, Inc.·00889024199064·
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code LXH·June 18, 2014
GOBED II
FDA Adverse Event
Other
·STRYKER MEDICAL QUEBEC LP·Product code FNL·October 19, 2010
ARMADA 14 PTA CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LIT·December 19, 2012
NEXGEN ROTATING HINGE KNEE ARTICULAR SURFACE WITH HINGE POST EXTENSION
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KRO·August 26, 2016
NEXGEN ROTATING HINGE KNEE OPTION FEMORAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code KRO·August 26, 2016
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·REGENCY, SENSOLOG III, AND DIALOG II PACEMAKERS
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·SENSOLOG (R) ALTERNATE PRODUCT TRAY
Pulse Generator, Permanent, Implantable
FDA Pre-Market Approval
FDA Class 3
·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
Implantable Pacemaker Pulse-Generator
FDA Pre-Market Approval
FDA Class 3
·SENSOLOG (R) MODEL 3038 SOFTWARE MODIFICATION