16 results
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45ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
FDA 510(k)
FDA Class 2
·Physical Medicine
ECG Module(AHA)
FDA UDI
SAMSUNG MEDISON CO., LTD.·08806167712532·
Oticon
FDA UDI
Oticon A/S·05707131285126·NERA2 PRO, DESIGNRITE 10 WL SIL
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486018283·MCK PF SAW GUIDE CADDY
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100011·BARRAQUER WIRE SPECULUM LARGE WITH TABS
Engage Partial Knee System
FDA UDI
Engage UNI LLC·B6951500780000·Tension Gauge
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017
ROC LUMBAR PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFIED STRAIGHT FIRE LASER FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Widex
FDA UDI
Widex A/S·05706069901153·WIDEX EVOKE E-FA (Mediterranean turquise ) 100,...
Widex
FDA UDI
Widex A/S·05706069923599·WIDEX MOMENT MBB3D 100 (Mediterranean turquoise)
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 21, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
FDA Enforcement
Class II
·Terminated·Ceterix Orthopedics, Inc.·November 18, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019