18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293487·
NA
FDA UDI
KEY SURGICAL, INC.·10849771049651·Steinmann Pins, Single trocar, 3 shank end, 5/6...
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771013051·Steinmann Pins, Single trocar, 3 shank end, 5/6...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484870·Steinmann pin w. trocar/3-shank _x000D_...
Steinmann pin w. trocar/3-shank 2.0mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM714800·Steinmann pin w. trocar/3-shank
2.0mm/...
Cushion
FDA UDI
Reison Medical AB·07350111832605·
AURECAST 40 B
FDA 510(k)
FDA Class 2
·Dental
VIVA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·September 25, 2025
SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code KIJ·April 22, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·July 2, 2008
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022