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

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Molekule Air Pro RX

FDA 510(k)
FDA Class 2 ·General Hospital

Waterlase Laser System Gold Handpiece

FDA UDI
Biolase, Inc.·00647529002278·A reusable contra-angled handpiece intended for...

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540256720·SCREWDRIVER

Waterlase Laser System Gold Handpiece

FDA UDI
Biolase, Inc.·00647529002483·A reusable handpiece intended for use with Wate...

STRABISMUS BABY SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896083752·STRABISMUS BABY SCISSORS STRAIGHT TUNGSTEN CARB...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694053853·M4 Autoclave Tray

TALOS®-C HA

FDA UDI
MEDITECH SPINE, LLC·B167522005000·

PTSii Personalized Tourniquet System, Twin

FDA UDI
Delfi Medical Innovations Inc·M995922005003·(Twin Channel, Single Port System) The Delfi PT...

LINER: MPACT FLAT PE HC LINER Ø36/E

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 5, 2022

SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS

FDA 510(k)
FDA Class 2 ·General Hospital

DINAMAP ADVANCED NIBP MODULE

FDA 510(k)
FDA Class 2 ·Cardiovascular

UNIVEC BIFURCATED SLIDING SHEATH SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

DEKA TETRA PRO COOLPEEL

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING SPA·Product code GEX·February 3, 2026

HIGH FLOW INSUFFLATION UNIT

FDA Adverse Event
Malfunction ·SHIRAKAWA OLYMPUS CO., LTD.·Product code HIF·February 10, 2025

ARCHITECT CA 19-9XR

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code NIG·November 7, 2016

PRESTIGE CERVICAL DISC SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code MJO·October 24, 2014

UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code DHA·August 11, 2011

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 1, 2013

AIM-V Medium REF AV.200/500

FDA Enforcement
Class II ·Ongoing·OXFORD IMMUNOTEC LTD·September 7, 2022

AIM-V Medium REF AV.200/500

FDA Recall
Open, Classified ·OXFORD IMMUNOTEC LTD 143 Park Road Abingdon United Kingdom·Product code OJN·July 7, 2022