14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lyme B. burgdorferi (IgM) MarStripe Test
FDA 510(k)
FDA Class 2
·Microbiology
DMP SINGLE BONDING
FDA 510(k)
FDA Class 2
·Dental
VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 3, 2025
AMISTEM H, HA COATED STEM SIZE 00 STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 15, 2017
VANGUARD ROCC POR FEM S60 L
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·February 3, 2026
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014
ARCHITECT STAT TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code MMI·June 17, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 22, 2011
BD BACTEC¿ MGIT¿ 960 SIRE KIT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 24, 2025
VANGUARD MONO FINNED STM TIB 71X8
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code JWH·August 9, 2023
VANGUARD ROCC POR FEM S60 L
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code JWH·February 20, 2025
MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems Nederlands·May 9, 2018
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016