21 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SILICONE TISSUE EXPANDER
FDA 510(k)
FDA Unclassified
·Unknown
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507331·
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699227·Titanium Base Abutment Round Anterior, Int. Hex...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108694123·Pilot Drill 2mm dia 23mm length
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306814242·Ochsner Hemostatic Forceps, Curved, 1x2 Teeth, ...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306814846·Ochsner Hemostatic Forceps, Curved, 1x2 Teeth, ...
VANGUARD COMPLETE KNEE CRUCIATE RETAINING POROUS & HA FEMUR LEFT 75MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MBH·December 16, 2016
ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB
FDA 510(k)
FDA Class 2
·Cardiovascular
AutoPulse Charger
FDA UDI
Zoll Circulation, Inc.·00849111065047·A Battery Charger is a stand alone unit intende...
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 25, 2024
LIFECARE PCA
FDA Adverse Event
Malfunction
·HOSPIRA INC·Product code MEA·April 12, 2013
PHILOS DR US
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·April 18, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
NORIAN DRILLABLE INJECT 10CC-STERILE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code MQV·February 7, 2018
Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials.
FDA Recall
Terminated
·Ciba Vision Corporation·Product code LPL·March 17, 2003
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022