12 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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Summit Spine Yellowstone Lumbar Interbody Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
INTERACTIVE SBM 3.7MMDX13MML 3.0MM PLAT
FDA Adverse Event
Injury
·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·October 29, 2025
VERSACLOSE, MODEL VC-200-01
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARALAST
FDA Adverse Event
Malfunction
·TAKEDA PHARMACEUTICALS U.S.A.,INC.·Product code LHI·May 5, 2026
XMAX MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code ERL·October 14, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 21, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 23, 2015
17-0572) ANK C/X IMPL D8/D7.0/L8
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·March 10, 2021
(17-0572) ANK C/X IMPL D8/D7.0/L8(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·June 18, 2021
(17-0572) ANK C/X IMPL D8/D7.0/L8(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·June 3, 2021
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