27 results · 25ms · Sources: EU EUDAMED, US FDA

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VALO Grand

FDA 510(k)
FDA Class 2 ·Dental

N/A

FDA UDI
GEORGE TIEMANN & CO.·B5821605510·FORCEPS

N/A

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551921·In-Ovation C/R RNC/BASE/EURO 018 UL5-5 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551821·IN-OVATION® C EURO 018 U5-5/L3-3 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100551811·IN-OVATION® C EURO 018 U5-5/L3-3 CS HK

BRIVANT GUIDEWIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

ORLOCATE SYSTEM MODEL ORL 100

FDA 510(k)
FDA Class 1 ·General Hospital

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MPRI·Product code LWS·October 10, 2014

PINNACLE 100 ACET CUP 52MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·June 10, 2013

CENTRAL VENOUS POLYETHYLENE CATHETER

FDA Adverse Event
COOK MEDICAL·Product code DRS·July 6, 2011

V.A.C. GRANUFOAM DRESSING

FDA Adverse Event
Injury ·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020

BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)

FDA Adverse Event
Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code MDB·April 1, 2022

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023

VASERLIPO SYSTEM

FDA Adverse Event
Injury ·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022

Artis zeego, Model Number 10280959

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

Artis zeego, Model Number 10280959

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017

Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 26, 2015