17 results · 26ms · Sources: EU EUDAMED, US FDA

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Atteris No-Sting Skin Protectant

FDA 510(k)
FDA Class 1 ·General Hospital

ADPER PROMPT, ADPER PROMPT L-POP

FDA 510(k)
FDA Class 2 ·Dental

CELLTRACKS AUTOPREP SYSTEM MODEL:9541

FDA 510(k)
FDA Class 1 ·Hematology

OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING MEDIUM LEFT 5MM THICK

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·February 24, 2017

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 10, 2013

MICRO SAGITTAL SAW

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 30, 2011

HARMONIC ACE 23CM W ERG HANDLE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·September 5, 2008

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FDA Adverse Event
Injury ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021

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FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021

ADVANCED PATELLA 35MM 3 PEG IMPLANT

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·January 9, 2024

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024