9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRYPTOSE BLOOD AGAR W/5% SHEEP BLOOD
FDA 510(k)
FDA Class 1
·Microbiology
AART NASAL IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PLANMED VERITY
FDA 510(k)
FDA Class 2
·Radiology
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 25, 2014
UNKNOWN LEFT ABGII HIP
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code KWY·October 23, 2012
LIBERTY CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·August 26, 2010
Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015