18 results · 21ms · Sources: EU EUDAMED, US FDA

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FreedomEdge Syringe Infusion System

FDA 510(k)
FDA Class 2 ·General Hospital

CoRoent

FDA UDI
Nuvasive, Inc.·00887517298928·CoRoent® XL-XW, 14x26x45mm

HAWKEYE™ Vertebral Body Replacement (VBR)

FDA UDI
Choice Spine, LP·00840996101042·VBR,SPACER,12X14X45,0 DEG

PMT® Halo Systems

FDA UDI
PMT CORPORATION·00650551113898·HALO, CTLSO VEST SMALL, COOLMAX LINER, 1211-1 M...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694020671·FPS 4.0mm x 45mm Standard Screw

Mediflex Modular III Basic Laparoscopic Instruments

FDA UDI
FLEXBAR MACHINE CORPORATION·00842102103995·Modular 3 Babcock Forceps,Insert only,5mmx45cm

Mediflex Modular III Basic Laparoscopic Instruments

FDA UDI
FLEXBAR MACHINE CORPORATION·00842102103988·Modular 3 Babcock Forceps,Ratcheted Handle/Sha...

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 18, 2023

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 18, 2023

OsteoMed

FDA UDI
OSTEOMED LLC·00845694075008·FPS 4.0 x 45mm Screw Sterile Qty 2

FUSEFORCE IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ACTIVA PRESTO PACK

FDA 510(k)
FDA Class 2 ·Dental

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026

PUMP MMT-522WWL PRDGM INSULIN CL EN ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·October 23, 2008

RSP SHOULDER

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code KWS·August 2, 2011

INFINITY DENTAL IMPLANT SYSTEM

FDA Adverse Event
Injury ·ACE SURGICAL SUPPLY CO.·Product code DZE·July 3, 2013

ENDOWRIST

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019