16 results · 45ms · Sources: EU EUDAMED, 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