19 results · 22ms · Sources: EU EUDAMED, US FDA

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Portable X-ray System

FDA 510(k)
FDA Class 2 ·Dental

MEGA PLUS MIS SPINE SYSTEM

FDA UDI
BK MEDITECH CO.,LTD.·08809763499968·Anti Torque Sleeve

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193115160·HA PEEK EVOS Straight, ,10mmx9mmx 26mm , BICONV...

VariAx

FDA UDI
Stryker GmbH·37613153067796·BONE SCREWS, CROSS-PIN

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR19812230101·Slim line expander 8 mm

Caplugs/Evergreen

FDA UDI
CAPlugs·00810044201123·10 mL Sterile Transport Vials with Caps

SNIFF POSITION PILLOWS/POPITZ PILLOWS

FDA 510(k)
FDA Class 2 ·Dental

ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

APG+ STRAIGHT HANDLE OUTER

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LXH·September 13, 2018

7900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEM GMBH·Product code JAA·August 10, 2011

PRIMEADVANCED

FDA Adverse Event
Injury ·IPG MFG SWITZERLAND·Product code LGW·November 4, 2014

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 12, 2013

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Enforcement
Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

FDA Recall
Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026

BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT

FDA Adverse Event
Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10

FDA Enforcement
Class II ·Ongoing·Linkbio Corp.·May 10, 2023

LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10

FDA Recall
Open, Classified ·Linkbio Corp.·Product code KRO·March 21, 2023

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024