20 results
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18ms
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Sources: EU EUDAMED, US FDA
TT AND HNTT BY HEMOCHRON
FDA 510(k)
FDA Class 2
·Hematology
3M™ Unitek™
FDA UDI
3M COMPANY·30605861027190·3M™ Unitek™ Stainless Steel First Primary Molar...
SS Crown 7LL
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001260·
Biopsy Handy
FDA UDI
SOMATEX Medical Technologies GmbH·04250195601872·
Barricade Coil System
FDA UDI
BALT USA LLC·00818053021251·Barricade Coil System (BCS) is intended for the...
MyndMove
FDA UDI
MyndTec Inc·06925209001266·
MyndMove
FDA UDI
MyndTec Inc·00692520001263·
Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746097706·DB BRACKET MASTER SERIES IBD MAX LEFT CUSPID 02...
Denovo Stainless Steel Primary Molar Crown
FDA UDI
Denovo Dental, Inc.·00810059293403·Denovo Stainless Steel Primary Molar Crown - 1s...
Revolution External Plating System
FDA UDI
Metalogix·00854641008082·Instrument + Hardware Tray
CONLIN MOLAR BAND
FDA UDI
Ortho Arch Company Inc·D90990012615·MOLAR BAND CONLIN RX UPPER RIGHT 41 1/2
XBraid S
FDA UDI
RIVERPOINT MEDICAL, LLC·00840277401175·Suture
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707050719·.022 LL6 CV DBT -25T 0A 4O
NA
FDA UDI
STRYKER CORPORATION·07613327643824·ADJUSTABLE PIN COLLET
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
FDA 510(k)
FDA Class 2
·Cardiovascular
FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAMITRODE TRIPOLE 16C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·May 28, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·January 7, 2013
ENDO GIA II 60-4.8 SULU
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·November 9, 2010
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021