35 results · 27ms · Sources: EU EUDAMED, 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