16 results · 28ms · Sources: EU EUDAMED, US FDA

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KOWA GENESIS-D

FDA 510(k)
FDA Class 2 ·Ophthalmic

ACTERA FEMORAL BROACH, SIZE 06

FDA UDI
Conformis, Inc.·00810933031497·ACTERA FEMORAL BROACH, SIZE 06

AU5, AU6

FDA 510(k)
FDA Class 2 ·Radiology

SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

TRUEBALANCE

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·August 13, 2014

QUILL SRS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009

QUILL SRS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009

QUILL SRS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009

DVT CALF GARMENTS STANDARD

FDA Adverse Event
Injury ·ARJOHUNTLEIGH POLSKA SP.Z.O.O.·Product code JOW·April 4, 2013

E SERIES DEFIBRILLATOR

FDA Adverse Event
Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 28, 2014

OPTIBOND FL

FDA Adverse Event
Injury ·KERR CORPORATION·Product code KLE·May 6, 2011

QUILL SRS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·March 12, 2009

WHITE STAR HIGH SPEED VIT CUTTER

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

WHITE STAR HIGH SPEED VIT CUTTER

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

QUILL SRS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·October 31, 2008

CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024