20 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
FDA 510(k)
FDA Class 2
·General Hospital
K121116
FDA UDI
Life Spine, Inc.·00190837016029·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016043·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016258·
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780377269·Integra® Jarit® Ryder Needle Holder, 5-7/8", Ca...
CHS
FDA UDI
Smith & Nephew, Inc.·03596010062345·AMBI COMPRESSION HIP SCREW PLATE 14SL 300MM 135D
PERFSCAPE V2.0
FDA 510(k)
FDA Class 2
·Radiology
TSO3 OZONE CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·October 7, 2003
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 20, 2015
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 30, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 10, 2013
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
LERADO GLOBAL·Product code ILS·May 20, 2013
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code INM·September 26, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 6, 2015
Artis Q biplane, Model Number 10848282
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018
Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 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. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018