14 results
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18ms
·
Sources: EU EUDAMED, US FDA
VARIABLE KV INTREX VSK 60 - 90 KVP
FDA 510(k)
FDA Class 2
·Dental
Archon
FDA UDI
Nuvasive, Inc.·00887517074331·Archon ACP Plate, 54mm 3-Level
Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k)
FDA Class 1
·General Hospital
FLORASEAL, MODEL FS350D
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 18, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHACARE CORP·Product code FRN·February 7, 2014
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·December 21, 2012
BIOLOX DELTA CER OPTION TYPE 1 TPR SLEVE -3
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·August 19, 2025
Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
TRILOGY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 14, 2025
BIOLOX DELTA CER OPTION HD 28MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·August 19, 2025
DUAL MOBILITY VIVACIT E
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·August 14, 2025
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020