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

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TRIGEN INTERTAN

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743656·ACHIMED ACHILLES SUPP SILVER II

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526743489·LEVAMED ANKLE SUPPORT SILVER II

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00816777026712·

Tiche PTA Balloon Dilatation Catheter

FDA UDI
BrosMed Medical Co.,Ltd.·06958481475630·

neoWave LS

FDA UDI
XENIX MEDICAL LLC·00818345023956·PADDLE SPREADER, 12MM

InTess Lumbar Cage

FDA UDI
Kalitec Direct LLC·B07312K0102120·Shaver, Open 12mm

Gorilla Plating System

FDA UDI
Paragon 28, Inc.·00889795009661·BOW & Arrow, Evans Plate, 12mm Wedge

OFFSET TIBIAL TRAY

FDA 510(k)
FDA Class 2 ·Orthopedic

KSEA CHARDONNES MORCELLATION KNIFE

FDA 510(k)
FDA Class 1 ·Obstetrics/Gynecology

NAOS

FDA UDI
HNM TOTAL RECON LLC·00841742101064·NAOS First MPJ Hemi, Porous Coated, CC - S, 17mm

Specials

FDA UDI
Seaspine Orthopedics Corporation·10889981173562·Trial LTL, 13x12x12mm, Flat 7 Deg

B-P TOTAL SHOULDER SYSTEM

FDA UDI
ENDOTEC, INC.·00814193025395·B-P SHOULDER HUMERAL STEM W/O HEAD W/ ULTRACOAT...

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

RADICAL

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·April 16, 2015

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 8, 2013

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Injury ·CORDIS LLC (PR)·Product code NIQ·April 5, 2011

PUMP MMT-722LCAS PRDGM INS SK EN LN

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·May 8, 2008

VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101

FDA Recall
Terminated ·bioMerieux·Product code LJC·August 6, 2003

Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

FDA Enforcement
Class II ·Terminated·Instrumed International, Inc.·October 8, 2014