26 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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