31 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IBS System
FDA 510(k)
FDA Class 2
·Dental
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220517000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220517070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676220517150·
ambIT* Cassette - Filter, Spike, and Neuraxial Connector
FDA UDI
Avanos Medical, Inc.·00193494001148·ambIT* Cassette - Filter, Spike, and Neuraxial ...
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00857595005541·Cassette - Filter, Spike, and Neuraxial Connector
LEONE SPA
FDA UDI
LEONE SPA·08033707022442·CALIBRA BANDS 2ND MOLAR n.SUR 17
VEO® Lateral Interbody Fusion System
FDA UDI
Choice Spine, LP·00840996134361·LATERAL,TRIAL HANDLE,SLIM
DEPUY PULSE CERVICAL CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNTHES DUAL-OPENING USS
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·March 23, 2022
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 13, 2022
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 25, 2022
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·August 20, 2025
ACRYSOF TORIC
FDA Adverse Event
Other
·ALCON RESEARCH LTD./HUNTINGTON·Product code MJP·October 29, 2008
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·July 18, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 16, 2022
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019