9 results
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19ms
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Sources: EU EUDAMED, US FDA
I.V. FILTER SET
FDA 510(k)
FDA Class 2
·General Hospital
Precision MIS Bunion System
FDA UDI
Paragon 28, Inc.·00889795132734·Sterilization Container for Ø1.6 x 230mm K-wire
COLLAGEN-ORC ANTIMICROBIAL MATRIX
FDA 510(k)
FDA Unclassified
·Unknown
STAPIX SUPERELASTIC IMPLANT BONE STAPLES
FDA 510(k)
FDA Class 2
·Orthopedic
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·December 20, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 14, 2014
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·December 21, 2012
OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.
FDA Recall
Terminated
·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021