19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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