10 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ABBOTT SMART CAP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bosworth Supergel
FDA UDI
Harry J Bosworth Company·H66809218181·Alginate Impression Pwd 1 lb bag, Reg. Set
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123847·K-WIRE - DOUBLE TROCAR 1.8mm DIA x 200mm
OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE
FDA 510(k)
FDA Class 2
·Neurology
Rebellion; Phantom Multi-Bite Kerrison Rongeur
FDA 510(k)
FDA Class 2
·Neurology
B1005, ACUCISE ENDOPYELOTOMY SYSTEM
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017
BIODESIGN SURGISIS URETHRAL SLING
FDA Adverse Event
Injury
·COOK BIOTECH·Product code FTM·January 14, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 6, 2014
STENOSCOPE
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD.·Product code JAA·December 8, 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