20 results · 23ms · Sources: EU EUDAMED, 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