18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Unity Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
SILICONE MCP
FDA UDI
Stryker GmbH·00886385021812·Instrument Tray Lid
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
FDA 510(k)
FDA Class 2
·Dental
EXPORT XT CATHETER, EXPORT AP CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SOFT-VU ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·ANGIODYNAMICS·Product code DQO·May 23, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 22, 2011
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code GEI·September 12, 2008
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·July 18, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·June 17, 2019
KIT BD MAX EXT ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·January 23, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·July 16, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·October 8, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·July 17, 2019
OSTEO-SITE BONE BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK INC·Product code KNW·July 11, 2019
STABLE BASE
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code DRX·December 18, 2018
SIGN IM NAIL
FDA Adverse Event
Injury
·SIGN FRACTURE CARE INTERNATIONAL·Product code HSB·August 16, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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