19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LINOS MOH HAND PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304232211·
TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION
FDA 510(k)
FDA Class 2
·Radiology
NANOBONE / GRANULATE
FDA 510(k)
FDA Class 2
·Orthopedic
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 4, 2014
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013
TOTAL ASR ACET IMP SIZE 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 22, 2011
UNSPECIFIED PRIMARY PLUM SET
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·October 3, 2024
UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·November 24, 2024
BIOMET BC R 1X40 US
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·November 26, 2025
BIOMET BC R 1X40 US
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·December 5, 2025
BIOMET BC R 1X40 US
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·November 26, 2025
VG 360 UNIV PST FM AUG 70X5
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 24, 2025
BMT SPLINED KNEE STM V2 20X80
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 24, 2025
UNKNOWN ARTICULAR SURFACE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 24, 2025
BIOMET OFFSET TIBIAL TRAY 71MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 24, 2025
VNGD TI FEM SSK 70MM LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 24, 2025
BMT SPLINED KNEE STM V2 20X120
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·February 24, 2025
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024