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