31 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CAPNOGRAPHY PAD (92516)
FDA 510(k)
FDA Class 2
·Anesthesiology
OsteoMed
FDA UDI
OSTEOMED LLC·00845694040518·PrimaLIF LLIF 17mm x 18mm Parallel Trial
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450407028·
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·00678467507587·12-Channel Customized Reusable Anorectal Catheter
Mui Scientific
FDA UDI
H & A Mui Enterprises Inc·10678467504866·Customized Single-Use Colonic 10ch Catheter
ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
FDA 510(k)
FDA Class 2
·General Hospital
LEESPEC DISPOSABLE VAGINAL SPECULUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Injury
·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·March 22, 2017
ACCELERATOR A3600
FDA Adverse Event
Malfunction
·INPECO SA·Product code JQP·December 20, 2024
AMISTEM H COLLARED FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 12, 2026
AMISTEM H COLLARED FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 13, 2026
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·Product code FRN·May 20, 2013
INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
LAMITRODE S8 SURGICAL LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 9, 2011
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire.
FDA Enforcement
Class II
·Ongoing·Arthrex, Inc.·November 21, 2018
VERSAFITCUP DM ACETABULAR CUP 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code MEH·December 29, 2014
COCR BALL HEAD 12/14 Ø 28 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·June 26, 2018
AMISTEM H, HA COATED STEM SIZE 2 LAT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 27, 2016
MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 16, 2018
MPACT ACETABULAR SHELL 62 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 7, 2020