23 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIRO Computed Tomography (CT) X-ray System
FDA 510(k)
FDA Class 2
·Radiology
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486020064·MCK BASEPLATE TEMPLATE (SIZE 6 LM/RL)
Monza Cervical Plate System
FDA UDI
Altus Spine, LLC·B41711601261·26mm Cervical Plate, 1 Level
LeMaitre Embolectomy Catheter
FDA UDI
Lemaitre Vascular, Inc.·00840663100552·2F 60 cm LeMaitre Embolectomy Catheter, eIFU
OsteoMed
FDA UDI
OSTEOMED LLC·00845694031608·Washer, 2.4mm Cannulated Screws
LeMaitre Embolectomy Catheter
FDA UDI
Lemaitre Vascular, Inc.·00840663100446·2F 60 cm LeMaitre Embolectomy Catheter
OsteoMed
FDA UDI
OSTEOMED LLC·00845694068109·Washer 2.4mm Cannulated Screws Sterile Qty 5
STELLATE GRIDVIEW
FDA 510(k)
FDA Class 2
·Neurology
ABSOANCHOR MICROIMPLANT
FDA 510(k)
FDA Class 2
·Dental
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·December 21, 2001
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
OPEN SPINE CLAMP DRIVER
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·March 30, 2019
11.0MM TI HELICAL BLADE 85MM-STERILE
FDA Adverse Event
Injury
·SYNTHES ELMIRA·Product code HSB·June 10, 2013
SOFTOUCH ANGIOGRAPHIC CATHETERS
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·June 2, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26
FDA Recall
Terminated
·Lemaitre Vascular, Inc.·Product code DXE·February 7, 2005
ROOT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·September 20, 2018
REUSABLE ADULT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 17, 2016
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·February 10, 2016