9 results
·
24ms
·
Sources: EU EUDAMED, US FDA
TROKEL /3 GONIO LASER LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123809·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 100mm
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123083·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 100mm
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467
FDA 510(k)
FDA Class 1
·Clinical Toxicology
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·January 17, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 6, 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