17 results
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18ms
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Sources: EU EUDAMED, US FDA
ROCHE REAGENT FOR LDH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CoRoent
FDA UDI
Nuvasive, Inc.·00887517382672·CoRoent XLR Cobb Elevator, Down Angled
3M™ Unitek™
FDA UDI
3M COMPANY·30605861027091·3M™ Unitek™ Stainless Steel First Primary Molar...
Barricade Coil System
FDA UDI
BALT USA LLC·00818053021206·Barricade Coil System (BCS) is intended for the...
SS Crown 2LL
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199001210·
MyndMove
FDA UDI
MyndTec Inc·00692520001218·
MyndMove
FDA UDI
MyndTec Inc·06925209001211·
CONLIN MOLAR BAND
FDA UDI
Ortho Arch Company Inc·D90990012110·MOLAR BAND CONLIN RX UPPER RIGHT 39
XBraid S
FDA UDI
RIVERPOINT MEDICAL, LLC·00840277401120·Suture
Elite®
FDA UDI
Ortho Organizers, Inc.·00190707050665·.022 LR6 CV STD -25T 0A 4O
PRE-FILLED CATHETER INFLATION SYRINGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
FDA 510(k)
FDA Class 2
·Immunology
MENTOR MEMORYSHAPE BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·December 20, 2024
DUAL EXTENSION
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
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 12, 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