9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ULTRA-BLASTER
FDA 510(k)
FDA Class 2
·Dental
Medtronic Reusable Instruments
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994806215·TRIAL 2980726 CAPSTONE 07 X 26MM
CALYPSO 4D LOCALIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Savion DLVR Guidewire, Savion FLX Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOPATH THORACIC ENDO LINEAR CUTTER WITH S/L
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code GAG·February 25, 1998
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 20, 2014
UNKNOWN DEPUY TIBIAL INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·February 27, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·February 7, 2011
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