15 results · 22ms · Sources: EU EUDAMED, US FDA

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BP PUMP

FDA 510(k)
FDA Class 2 ·Cardiovascular

Bosworth Hydrox

FDA UDI
Harry J Bosworth Company·H66809210741·Cavity Liner 6 pk Base & Catalyst Dentin Kit

PAQ.210X295X100/QT-HS/NK 210-3-295 (C/R

FDA UDI
AB MEDICA GROUP, S.A.·08428763057277·

De Soutter Medical

FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123069·K-WIRE - DOUBLE TROCAR 1.0mm DIA x 100mm

STAR TOTAL ANKLE REPLACEMENT

FDA Adverse Event
Injury ·SMALL BONE INNOVATIONS, INC.·Product code NTG·July 24, 2014

STAR TOTAL ANKLE REPLACEMENT

FDA Adverse Event
Injury ·SMALL BONE INNOVATIONS, INC.·Product code NTG·August 13, 2014

VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

SCENIUM 2.0

FDA 510(k)
FDA Class 2 ·Radiology

RCSP RETROGRADE CANNULA

FDA Adverse Event
Injury ·MEDTRONIC PERFUSION SYSTEMS·Product code DWF·November 13, 2013

4 SHOOTER SAEED MULTI-BAND LIGATOR

FDA Adverse Event
Malfunction ·COOK ENDOSCOPY·Product code MND·November 11, 2010

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 17, 2013

OT PING ENHANCED METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2014

RT-5100 Refractor, a component of the Epic-5100 System.

FDA Enforcement
Class III ·Terminated·Nidek Inc.·December 26, 2018

Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024