12 results
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28ms
·
Sources: EU EUDAMED, US FDA
SELICOR, MODELS A100 & D100
FDA 510(k)
FDA Class 2
·Physical Medicine
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001328·Knee Immobilizer
Midway Everyday
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717102523·Prophy Angles Disposable Firm Latex Free, Pkg/500
UMBICUT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
WANDY SILICONE CONDUCTIVE RUBBER PAD
FDA 510(k)
FDA Class 2
·Neurology
KNEE IMMOB.BLUE CNVS 22" MEDIU
FDA Adverse Event
Injury
·DEROYAL INDUSTRIES, INC·Product code ITQ·September 18, 2002
TRIDENT 0 DEG INSERT 40MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·August 25, 2017
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
UNKNOWN·Product code IKX·March 25, 2013
LAMITRODE TRIPOLE 8 SURGICAL LEAD
FDA Adverse Event
Other
·ST. JUDE MEDICAL- NEUROMODULATION·Product code LGW·March 10, 2011
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·March 26, 2008
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
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