18 results · 20ms · Sources: EU EUDAMED, US FDA

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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