19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Amis K Long
FDA 510(k)
FDA Class 2
·Orthopedic
MECTACER BIOLOX OPTION HEADS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 7, 2025
CoRoent
FDA UDI
Nuvasive, Inc.·00887517629715·CoRoent Ant TLIF Ti, 12x10x40mm 15°
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005176·Pain Control Kit - Basic with 420 mL MediBag an...
ambIT*
FDA UDI
Avanos Medical, Inc.·00193494000967·ambIT* Pain Control Kit - Basic w/420mL MediBag...
ELMED INCORPORATED
FDA UDI
ELMED INCORPORATED·00842180157682·LAPAROSCOPIC PORT CLOSURE GUIDE, 5MM DIA., 10 C...
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540365300·Bone Screws, Cross-Pin
BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1
FDA 510(k)
FDA Class 2
·Cardiovascular
WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
ANIMAS CORPORATION·Product code LZG·August 23, 2011
PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·November 4, 2008
ATLAS PLUS VR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013
SKINTACT
FDA Adverse Event
Injury
·LEONHARD LANG GMBH·Product code GEI·March 8, 2023
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
EasyPoint Needle, 25G x 5/8", REF: 82091
FDA Enforcement
Class II
·Ongoing·Retractable Technologies, Inc.·March 20, 2024
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
FDA Enforcement
Class II
·Ongoing·Micro-X Ltd.·October 5, 2022
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025