25 results · 25ms · Sources: EU EUDAMED, US FDA

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OEC 9900 ELITE

FDA 510(k)
FDA Class 2 ·Radiology

KING SEPTEMS

FDA Adverse Event
Malfunction ·KING SEPTEMS·Product code LMA·November 1, 2012

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00812564030887·4 SHEET PACK

NOVO Health Services, LLC

FDA UDI
NOVO HEALTH SERVICES, LLC·00810019800597·Sheet, 4-Pack

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690129868·PS Insert, Size 6 x 13mm

PMT® CORPORATION HALO

FDA UDI
PMT CORPORATION·00650551045830·TRACTION BAIL WITH HEADBLOCK ATTACHMENT HARDWARE

Tiche PTA Balloon Dilatation Catheter

FDA UDI
BrosMed Medical Co.,Ltd.·06958481477740·

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383555616·Gutta Percha Points is used to root canal filin...

Zavation

FDA UDI
Zavation LLC·00842166188174·Custom PLIF SIZER

AED

FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657018159·Wide Jaw Punch medium 15 degree up milled 3.5mm...

K2M General Instruments

FDA UDI
VB Spine LLC·10888857551329·Offset Blade Left Size 70 mm

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

BIOMED WOUND CLEANSER

FDA 510(k)
FDA Unclassified ·Unknown

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 20, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

SENSAR ACRYLIC IOL

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·June 10, 2011

BD MAX¿ CPO

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·May 13, 2025

BD MAX¿ CPO

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code OOI·January 21, 2025

KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012

KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

FDA Enforcement
Class II ·Terminated·King Systems Corp.·November 28, 2012