11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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JuggerKnot Soft Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
AGXO
FDA UDI
Oticon A/S·05707131282088·H150V2, MINIBTE 312 WL 85 CNB AGXO
REZUM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·April 23, 2024
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962161999·GRAVES VAGINAL SPECULUM, W/SMOKE EVACUATION TUB...
COMPUTED DENTAL RADIOGRAPHY
FDA 510(k)
FDA Class 2
·Dental
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 6, 2013
TERUMO CDI 540 CALIBRATOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DRY·June 21, 2011
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·September 21, 2021
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