23 results
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44ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MULTIFUNCTIONAL LINEAR PEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bur PM2-MIS D150 diam Ø3.0 St
FDA UDI
Bien-Air Surgery SA·17630055506297·
Ni-Ti - Archwire
FDA UDI
ORMCO CORPORATION·00889989027068·NI-TI BROAD ARCH UPSML 0175 0175 PK10
OsteoMed
FDA UDI
OSTEOMED LLC·00845694002110·Mini, Locking Strut Plate, Curved, 2x4 Hole
ENDO SMARTCAP (100501)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869679619·MOSS MIS XT Rod Inserter
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869608206·TELIX K Inserter Cage/Trial
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180509760·Curved Thoracic Probe, Ball Handle
MOBIVISION
FDA 510(k)
FDA Class 2
·Radiology
ELECTROSURGICAL GENERATOR, MODEL S1
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
1818910-2019-100501
FDA Adverse Event
Injury
·August 8, 2019
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01
FDA 510(k)
FDA Class 2
·Orthopedic
FREESTYLE LIBRE 3 PLUS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC·Product code QBJ·April 30, 2026
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 8, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·May 13, 2011
GALAXY G3 MINI 2MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·October 26, 2020
GALAXY G3 2.5MM X 5CM
FDA Adverse Event
Death
·MEDOS INTERNATIONAL SARL·Product code KRD·October 14, 2020
ZIMMER AIR DERMATOME
FDA Adverse Event
Injury
·ZIMMER SURGICAL, INC.·Product code GFD·January 17, 2017
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
FDA Enforcement
Class II
·Terminated·TriMed Inc.·June 27, 2018