11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
FDA 510(k)
FDA Class 2
·Microbiology
LUCENT MAGNUM+
FDA 510(k)
FDA Class 2
·Orthopedic
CERULEAU ELECTROSURGICAL PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JRNY BCS PAT RESRF RD 35 MM STD
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017
TENDRIL ST
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·July 27, 2011
M2A-38 CUP NON FLARED SZ 54MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 21, 2013
INNOVA 2000
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEM SCS·Product code IZI·September 30, 2008
ULTRAXX NEPHROSTOMY BALLOON AND SET
FDA Adverse Event
Malfunction
·COOK INC·Product code LJE·August 8, 2024
JOURNEY POLY TIBIAL INSERT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017