20 results · 28ms · Sources: EU EUDAMED, US FDA

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ELEXOMA MEDIC

FDA 510(k)
FDA Class 2 ·Neurology

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496070412·BE YOU ICON CURVY, SIZE L-XL, BLU NAVY, GRADUAT...

Paltop

FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696547·Fully Guided Sleeve Wide, L25mm Drill (Purple)

Tiche PTA Balloon Dilatation Catheter

FDA UDI
BrosMed Medical Co.,Ltd.·06958481475951·

LYNX

FDA UDI
HNM TOTAL RECON LLC·00841742111322·LYNX ø4.0mm Cancellous Screw, Full Thread, Ti -...

StrykeFlow

FDA UDI
STRYKER CORPORATION·07613327051803·Laser Fiber Guide, Flexible

FLEXIBLE ENDOSCOPIC SCISSORS

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

VISION R/F TILTING TABLE

FDA 510(k)
FDA Class 2 ·Radiology

SPECTRA WAVEWRITER?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 24, 2025

LINEAR 3-6

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 19, 2020

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 4, 2024

CATHETER MOUNT

FDA Adverse Event
Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZO·March 5, 2008

CARTRIDGE

FDA Adverse Event
Injury ·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

ACCU-CHEK SPIRIT

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 19, 2011

SUPER LAG SCREW

FDA Adverse Event
Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code HWC·June 30, 2008

Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.

FDA Enforcement
Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.

FDA Enforcement
Class II ·Terminated·Instrumed International, Inc.·December 17, 2014

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

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