11 results
·
28ms
·
Sources: EU EUDAMED, US FDA
BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984546·anteriors; shade C4; mould O 52
IMMUNODOT RUBELLA TEST
FDA 510(k)
FDA Class 2
·Microbiology
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IBALANCE TKA TIBIAL TRAY, SIZE 7
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code JWH·August 29, 2016
IBAL TKA FEM,PS SZ 7,LFT,CEMENTED
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code JWH·August 29, 2016
RIATA ST OPTIM ACTIVE FIXATION
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 28, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 6, 2014
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
FDA Enforcement
Class II
·Terminated·Arthrex, Inc.·March 30, 2016
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024