27 results
·
35ms
·
Sources: EU EUDAMED, US FDA
REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
neoWave C
FDA UDI
XENIX MEDICAL LLC·00840493415024·Rasp, Universal
TiWAVE C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07320K0100060·Rasp, Universal
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100160·Compressor, Canoe
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100060·Tray Insert, Lumbar Screws, 10 x 10 Assembly
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521010086D0·10 x 85 mm SI Implant with HA Coating
WILSON-COOK REUSABLE HOT BIOPSY FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVIA CENTAUR TROPONIN ULTRA (TNI-ULTRA) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·October 24, 2014
ADVIA CENTAUR TROPONIN ULTRA ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·October 7, 2014
AXSYM DIGOXIN III
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·May 11, 2007
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·February 11, 2011
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·July 3, 2018
ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·November 20, 1997
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·March 30, 2021
ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·June 25, 2014
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·November 2, 2018
ADVIA CENTAUR XP TROPONIN ULTRA (TNI ULTRA) ASSAY
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·July 3, 2014
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·February 4, 2020