11 results
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18ms
·
Sources: EU EUDAMED, US FDA
AIRTEC2 LOW AIR LOSS THERAPY BED
FDA 510(k)
FDA Class 2
·Physical Medicine
artegral
FDA UDI
Merz Dental GmbH·D7091970364·anteriors; shade C4; mould ITL
Collagen Meniscus Implant XL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
100KGY E-POLY MAXROM ACETABULAR LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
SEE H10 NARRATIVE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·September 11, 2017
UNKNOWN LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015
INTERLOCK¿-35
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KRD·February 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
ANIMAS CORPORATION·Product code LZG·July 31, 2014
NEPTUNE 2 ROVER ULTRA (120V)
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·January 18, 2011
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022