9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROPAK
FDA 510(k)
FDA Class 2
·General Hospital
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690113898·PS-R Insert, Size 1 x 18mm
ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066
FDA 510(k)
FDA Class 2
·Cardiovascular
SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.
FDA 510(k)
FDA Class 2
·Anesthesiology
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·October 22, 2025
MBT POR KEEL TIB TRAY SZ3
FDA Adverse Event
Injury
·DEPUY IRELAND ? REG. # 9616671·Product code NJL·January 22, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
TENDRIL ST
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
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