17 results
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21ms
·
Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARIX Cannulated Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Plum
FDA UDI
ICU Medical, Inc.·10887787005315·LIFESHIELD, Primary PLUM Set, Orange Polyethyle...
VITA TITANKERAMIK
FDA UDI
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft·J017B2339120·VITA TITANKERAMIK OPAQUE DENTINE, 2R2.5, 12 g
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981041939·39x30mm Trial Rasp 12mm 8 deg
ICU MEDICAL PRIMARY PLUM SET ORANGE PE LINED
FDA Adverse Event
Injury
·ICU MEDICAL, INC.·Product code FPA·December 13, 2022
ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CRADLE PACS
FDA 510(k)
FDA Class 2
·Radiology
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·April 22, 2026
BD INTIMA-II CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·July 6, 2020
INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code FOZ·May 28, 2020
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·November 13, 2008
ASR ACETABULAR IMPLANT 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 6, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 18, 2013
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·June 2, 2025
ALINITY I TOXO IGM REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code LGD·September 11, 2025
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
FDA Enforcement
Class I
·Terminated·Animas Corporation·April 10, 2013
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023