12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Spectra Cashmere
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Orthos
FDA UDI
ORMCO CORPORATION·00889989029949·ORTHOS CM SST 016 X 022 UPSM PK10
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·February 12, 2021
GS III SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OBIX PERINATAL DATA SYSTEM 7.0
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·June 27, 2019
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
CLICKX PEDICSCR Ø6.2 SELF-TAP MONOAX L50
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·June 26, 2013
900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 19, 2011
PROLIEVE THERMODILATATION KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 26, 2008
Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·November 20, 2013