20 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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S2 FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
ROLLO 210x200x25E/QT-HS/PRINTER
FDA UDI
AB MEDICA GROUP, S.A.·08428763078364·
2040 Ceramic Brackets
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746005305·COSMETIC 20/40 UL CUSP 022 T=0 A+11 R4M
MICROPOWER
FDA UDI
Conmed Corporation·20845854023805·MICROPOWER HIGH SPEED DRILL, PERMANENT LEVER
ULTRAPOWER
FDA UDI
Conmed Corporation·10845854008751·ULTRAPOWER BUR, ROUND(RED), 3 MM
MICROPOWER
FDA UDI
Conmed Corporation·10845854023808·Micropower High Speed Drill, Permanent Lever
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
3D-MSPECT
FDA 510(k)
FDA Class 2
·Radiology
FORTADERM WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·June 14, 2021
UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LTJ·August 4, 2011
CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·September 5, 2018
UNICEL DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 28, 2011
FIRSTPASS SUTURE PASSER
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GAT·March 20, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code LWS·March 16, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE SJ·Product code JPA·March 28, 2008
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·March 28, 2024
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014