16 results
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29ms
·
Sources: EU EUDAMED, US FDA
Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
FDA 510(k)
FDA Class 2
·Microbiology
VALUGRIP
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975025487·ValuGrip Small Nitrile Powder-Free Exam Gloves ...
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088002·
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962101926·ETHOS PRO SMALL JOINT ANCHOR, TITANIUM, 2.9mm x...
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
FDA 510(k)
FDA Class 2
·Dental
PALM-PRO POWDER FREE NITRILE EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·December 7, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·January 8, 2017
SEDLINE KIT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017
PLUM A + DRIVER NEW
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 30, 2013
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 6, 2011
ACCUFIX
FDA Adverse Event
Injury
·TELECTRONICS PACING SYSTEMS·Product code DTB·September 5, 2008
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016