32 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HHM
FDA UDI
Oticon A/S·05707131351586·G500 SC, BTE PP 13 2.4G 105 C057 TAR HHM
METAPHYSARY BROACH ESOP LEFT SIZE 10
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489017568·
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136022543·7450M FACE MASK-HDGR & 2700 MA
NA
FDA UDI
Synthes GmbH·10886982142672·2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2017560·2.4mm Cortex Screw, T8 Stardrive, Self-Tapping,...
WELCH ALLYN ABPM 6100
FDA 510(k)
FDA Class 2
·Cardiovascular
LUNAR REPORT GENERATOR II
FDA 510(k)
FDA Class 2
·Radiology
MICA SCREW
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·October 4, 2019
MICA SCREW
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·October 4, 2019
MICA SCREW
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·October 4, 2019
MICA SCREW
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·October 4, 2019
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 29, 2025
INBONE® II
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·February 15, 2017
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·September 5, 2018
INBONE® I
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·February 15, 2017
SYMPHONY
FDA Adverse Event
Injury
·ELA MEDICAL, S.A.S.·Product code DXY·October 14, 2008
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GAM·July 2, 2013
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023