3,182 results · 26ms · Sources: EU EUDAMED, US FDA

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GXR-Series Diagnostic X-Ray System

FDA 510(k)
FDA Class 2 ·Radiology

MITEK

FDA UDI
Medos International Sàrl·10886705029167·HD EP Arthroscope/Sinuscope compatible with Mit...

Ophthalmic Scissors

FDA UDI
KATENA PRODUCTS, INC.·00841668105207·HOLLAND DALK SICISSORS LEFT

Symmetry Charnley

FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482061206·Symmetry® Blade; Charnley Retractor; Rounded; 1...

Portex

FDA UDI
ICU MEDICAL, INC.·15019517071443·

Maven Patient-Specific Instrumentation

FDA 510(k)
FDA Class 2 ·Orthopedic

HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 10, 2014

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 9, 2011

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

NI

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·July 24, 2019

NI

FDA Adverse Event
Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·July 24, 2019

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Injury ·TANDEM DIABETES CARE·Product code OZO·November 6, 2019

CADD LEGACY 1 PUMP

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC·Product code FRN·May 28, 2019

AMS INFLATABLE PENILE PROSTHESIS

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - MINNETONKA·Product code FHW·August 21, 2017

NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

FDA Adverse Event
Malfunction ·COCHLEAR LTD·Product code MCM·July 23, 2019

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

NUCLEUS CI512 COCHLEAR IMPLANT WITH CONTOUR ADVANCE ELECTRODE

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code MCM·June 23, 2019

NGAGE NITINOL STONE EXTRACTOR

FDA Adverse Event
Malfunction ·COOK INC·Product code FFL·February 25, 2019

I-STAT TROPONIN (CTNI) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code MMI·November 13, 2019