27 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICRUS MICROCOIL DELIVERY SYSTEM, MDS03
FDA 510(k)
FDA Class 2
·Neurology
PRESIDIO 10 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
PRESIDIO 18 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040054724·Polycarbonate Crowns
artVeneer life
FDA UDI
Merz Dental GmbH·D7092002056·artVeneer life upper posteriors, S, B1
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112496·BARRON VACUUM TREPHINE 7.5MM
BIOCELL MAMMARY PROSTHESIS
FDA Adverse Event
MCGHAN MEDICAL CORP.·Product code FWM·May 18, 1994
HEYER-SCHULTE MAMMARY PROSTHESIS
FDA Adverse Event
V. MUELLER DIV. BAXTER HEALTHCARE CORP.·Product code HNR·May 18, 1994
Persona® Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024469631·
PERSONA™ Trabecular Metal™
FDA UDI
Zimmer, Inc.·00889024228979·
Persona® Trabecular Metal®
FDA UDI
Zimmer, Inc.·00889024469648·
PERSONA™ Trabecular Metal™
FDA UDI
Zimmer, Inc.·00889024228986·
BIO-LIPID HUMAN SERUM HDL AND LDL CALIBRATORS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAP PORP, CAP TORP
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
PORTEX GENERAL ANESTHESIA CIRCUITS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022
ASR UNI FEMORAL IMPL SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 13, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·February 28, 2011
FAST-CATH HEMO INT SWARTZ SRO, 8F, 60CM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code DYB·February 18, 2008
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023