15 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MyndMove System, MyndMove Functional Electrical Stimulator
FDA 510(k)
FDA Class 2
·Neurology
CALYPSO SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN ANKYLOS CX ABUTMENT
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·January 31, 2023
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 21, 2011
BIAFINE TOPICAL EMULSION
FDA Adverse Event
Injury
·VALEANT USA·Product code MGQ·June 12, 2013
COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
(17-0564) ANK C/X IMPL C11/D5.5/L11
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLU IH AB)·Product code DZE·February 16, 2021
(17-0564) ANK C/X IMPL C11/D5.5/L11(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·June 2, 2021
(17-0564) ANK C/X IMPL C11/D5.5/L11(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·June 21, 2021
(17-0564) ANK C/X IMPL C11/D5.5/L11(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·June 14, 2021
(17-0564) ANK C/X IMPL C11/D5.5/L11(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·June 15, 2021
(17-0564) ANK C/X IMPL C11/D5.5/L11(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·June 5, 2021
(17-0564) ANK C/X IMPL C11/D5.5/L11(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·July 30, 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