19 results · 22ms · Sources: EU EUDAMED, US FDA

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Magic3 Go Intermittent Urinary Catheter

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04064984699571·GENUMEDI PSS BLUE, SIZE V

CoRoent

FDA UDI
Nuvasive, Inc.·00887517637871·CoRoent Ant TLIF PEEK, 15x10x34mm 15°

AGXO

FDA UDI
Oticon A/S·05707131287496·H110V2, MINIRITE 312 WL TC AGXO

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306803864·Conrad Separator, 20cm

Ophthalmic Speculum

FDA UDI
KATENA PRODUCTS, INC.·00841668100134·KRATZ-BARRAQUER SPECULUM LEFT EYE

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 17, 2023

CIE FOLDAWAY WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

SYSTEMS INTEGRATION MODEL: ENDOALPHA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MINILINK TRANSMITTER

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code MDS·October 7, 2014

ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·June 6, 2013

HEARTSTART MRX

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·June 7, 2011

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

da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 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, 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

Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024