15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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