18 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Excia Total Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486009328·MCK UNI INS TRAY, UPPER
Oticon
FDA UDI
Oticon A/S·05707131284648·NERA2 PRO, RITE 312 WL DBL
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038214·TRIAL RASP, ANGLED, 22MM WIDE, 14MM
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038184·TRIAL RASP, ANGLED, 22MM WIDE, 8MM
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038191·TRIAL RASP, ANGLED, 22MM WIDE, 10MM
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038177·TRIAL RASP, ANGLED, 22MM WIDE, 6MM
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038207·TRIAL RASP, ANGLED, 22MM WIDE, 12MM
ENGAGE
FDA UDI
Smith & Nephew, Inc.·00885556876220·TIBIAL ANCHOR PILOT CUTTER 5/6 LONG
Engage Partial Knee System
FDA UDI
Engage UNI LLC·B6951500620000·Tibial Anchor Pilot Cutter
GEMIFLOXACIN, 5UG BBL SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
INFILTRATION KIT
FDA 510(k)
FDA Class 2
·Dental
Engage Partial Knee System
FDA UDI
Engage UNI LLC·B695150062000A0·Tibial Anchor Pilot Cutter
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 30, 2013
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012