35 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Bigfoot Unity Diabetes Management System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SprintRay Nightguard Flex 2 - Simply Clear - 1 Kg
FDA UDI
Sprintray, Inc.·00850039704628·SprintRay NightGuard Flex 2 is indicated for th...
Mediflex Laparoscopic Instruments - Needle Holders
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102112140·Modular Needle Holder w/Radel Handle, 5mm x 45...
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112748·BARRON VACUUM PUNCH 7.25MM
Tissue Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668112847·BARRON ARTIFICIAL ANTERIOR CHAMBER
Fluid Retention Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668112854·VIDAURRI FLUID RETENTION WELL 8.7MM
Mediflex Laparoscopic Instruments - Needle Holders
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102112157·Ins for Mod Needle Holder, Straight Jaw
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
FDA 510(k)
FDA Class 2
·Cardiovascular
X-Pac Expandable Lumbar Cage System
FDA 510(k)
FDA Class 2
·Orthopedic
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON ¿ IRVINE TECHNOLOGY CENTER·Product code HQC·June 28, 2013
ADULT BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·October 16, 2008
INION CPS BIODEGRADABLE FIXATION SYSTEM
FDA Adverse Event
Injury
·INION OY·Product code JEY·August 3, 2011
HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·September 2, 2021
MAGNETOM Vida Fit. Model Number: 11410481.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·September 1, 2022
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·September 13, 2022
PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OMD·December 21, 2021
ILS 21MM CURVED
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 19, 2022
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·April 4, 2024
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·April 4, 2024