15 results · 23ms · Sources: EU EUDAMED, US FDA

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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