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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HemoSphere Advanced Monitor, HemoSphere Pressure Cable
FDA 510(k)
FDA Class 2
·Cardiovascular
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197544627·Gregory needleholder, for large needles
10mm r...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197544634·Gregory needleholder,for large needles
10mm r...
N/A
FDA UDI
Ortho Development Corporation·00822409129690·Uni Knee Keeled Tibial Tray Trial Size 8 Left
CURE CATHETER CLOSED SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNAPSE OBLIQUUS MIP/MPR/FUSION
FDA 510(k)
FDA Class 2
·Radiology
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·October 17, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 20, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 1, 2011
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
FDA Enforcement
Class II
·Terminated·Pentax of America Inc·July 26, 2017
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