32 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Checkme O2 Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
K991088
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·September 27, 2018
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·October 9, 2008
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·July 19, 2011
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·August 14, 2013
ROI-C IMPLANT, UNKNOWN SIZE
FDA Adverse Event
Injury
·LDR MÉDICAL·Product code OVE·August 24, 2021
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·December 2, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·October 23, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·December 2, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·November 30, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code FDI·December 11, 2020
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·COOK ENDOSCOPY·Product code KNS·August 31, 2021
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·January 9, 2024
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·January 9, 2024
ACUSNARE POLYPECTOMY SNARE
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code FDI·December 5, 2022