20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AN1087 Dosimeter
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171027928·PESSARY, CUP #6, W/O SUPPORT, 80/48mm
AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
CORDIS AMIIA .014 PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 6, 2013
ECHELON*FLEX45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 6, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
GALAXY G3 6MM X 20CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
GALAXY G3 XSFT 3MM X 4CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
GALAXY G3 8MM X 24CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
ASAHI GLADIUS EX
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025
ASAHI GLADIUS EX
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026
GALAXY G3 7MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
GALAXY G3 6MM X 10CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
GALAXY G3 6MM X 15CM
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SARL·Product code KRD·June 14, 2022
da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015
da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·April 15, 2015