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

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SmoothSkin Pure

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Vilex Jones Fracture Guidewire

FDA UDI
VILEX LLC·00841731123558·Wire, Guide 1.8x200mm Sgl Trocar

MICRO FORCEPS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896094024·MICRO FORCEPS STRAIGHT TUNGSTEN CARBIDE DUST TI...

Sizer

FDA UDI
Treace Medical Concepts, Inc.·00810111222747·Hammertoe Implant Sizer

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114100·SIMCOE CORTEX EXTRACTOR 21GA 0.4MM PK/10

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306805158·Neivert Osteotome. Curved, Left, 20cm

Initia Total Hip System

FDA UDI
KYOCERA CORPORATION·04547898306419·STD LINER 40-72/74

Carnegie Surgical LLC

FDA UDI
Carnegie Surgical LLC·G1412001840·Neivert Osteotome - Curved, Left: 20cm/8Inch

DESS dental smart solutions

FDA UDI
TERRATS MEDICAL SL.·08435457200406·Conical BL

QUANTUM II

FDA Adverse Event
Malfunction ·INTERMEDICS, INC.·Product code DXY·November 7, 1996

AUDIOSCREENER OAE

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

HOMMED CENTRAL STATION

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD VACUTAINER® TUBE GLU PLH 13X75 4.0 BLBLCE GR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 14, 2023

METRIX AIR

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·February 22, 2017

CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·August 10, 2011

DA VINCI S SURGICAL SYSTEM

FDA Adverse Event
Other ·INTUITIVE SURGICAL, INC.·Product code NAY·September 26, 2008

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 1, 2013

BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·July 21, 2023

BRAND NAME PHYSICA KNEE - FIXED TIBIAL PLATE CEMENTED #7

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code JWH·December 1, 2023

EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·July 10, 2024