24 results
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64ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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COMBE PRODUCTS, INC.
FDA registration
COMBE PRODUCTS, INC.·1 product·🇺🇸 United States
Vagisil Prohydrate Natural Feel Internal Vaginal Moisturizing Gel
FDA UDI
COMBE PRODUCTS, INC.·00011509060501·Vagisil Moisturizing Gel is an Over-The-Counter...
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A
FDA Enforcement
Class II
·Ongoing·Alcon Research LLC·July 16, 2025
STFX SYM PDS+ UNI VIO 24IN 1 S/A OS-8
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code NEW·October 11, 2021
ASTROGLIDE
FDA Adverse Event
Malfunction
·COMBE INC·Product code KMJ·January 16, 2024
RELAY PRO THORACIC STENT-GRAFT SYSTEM
FDA Adverse Event
Malfunction
·BOLTON MEDICAL, INC.·Product code MIH·April 13, 2023
RELAY PRO NBS THORACIC STENT-GRAFT SYSTEM
FDA Adverse Event
Injury
·BOLTON MEDICAL, INC.·Product code MIH·November 9, 2023
TOTAL ASR ACET IMP SIZE 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·December 11, 2012
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·December 18, 2014
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·March 20, 2024
QDOT MICRO¿ CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code OAE·May 9, 2025
ID NOW COVID-19
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·May 14, 2020
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HTO·December 27, 2016
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·March 9, 2015
BENDING/CUTTING PLIERS
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HTC·April 14, 2016
BROKEN SCREW EXTRACTOR HEX COUPLING
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HWB·February 23, 2015
VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code MZF·January 10, 2024
CONICAL EXTRACTION SCREW
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FSM·April 15, 2014
SOCKET WRENCH WITH STRAIGHT HANDLE-6MM WIDTH ACROSS FLATS
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code FSM·October 10, 2014
RELAY PRO THORACIC STENT-GRAFT SYSTEM
FDA Adverse Event
Malfunction
·BOLTON MEDICAL, INC.·Product code MIH·May 5, 2023