26 results · 28ms · Sources: EU EUDAMED, US FDA

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PATRIOT TRANSCONTINENTAL M SPACERS

FDA 510(k)
FDA Class 2 ·Orthopedic

Performance Health

FDA UDI
Performance Health Supply, LLC·00885914087794·Moist Electrical Heating Pad, Large 13" x 13"

JOBST Bella Strong

FDA UDI
BSN MEDICAL, INC.·00035664009571·BELLA STRONG 20-30 MM HG ARMSLEEVE DOT BAND SIZ...

ILIZAROV SYSTEMS

FDA UDI
MEDICALPLASTIC SRL·28033201841864·THREADED ROD 350MM LENGTH

Transducer Cover

FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436114049·Sterile (14x147cm) telescopically folded CIV-Fl...

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776186333·SUPERCUT STEVEN TEN SCS CVD

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113301·STAB KNIFE 45 DEGREE (BX/5)

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780375371·Integra® Jarit® Stevens Tenotomy Scissors, 7", ...

KIT BD MAX ENTERIC VIRAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·November 22, 2022

CT COLONOGRAPHY/NAVIGATOR2

FDA 510(k)
FDA Class 2 ·Radiology

COMPLEXED PSA MICROTITER ELISA

FDA 510(k)
FDA Class 2 ·Immunology

NIAGARA® Lateral Access System

FDA UDI
VB Spine LLC·10888857517202·Cranial Caudal Blade, Size 200 mm

SAGITTAL BLADE 25.0X0.89X75MM

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code GFA·May 9, 2013

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·September 19, 2014

FISHER & PAYKEL FLEX FIT NASAL MASK

FDA Adverse Event
Injury ·FISHER & PAYKEL·Product code BZD·May 20, 2011

BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·October 11, 2022

Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

FDA Enforcement
Class III ·Terminated·Illumina Inc·December 31, 2014

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025

Model Number L210 PROPONENT SR SL Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025