11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
FDA 510(k)
FDA Class 2
·Orthopedic
Bosworth
FDA UDI
Keystone Industries·H66809214811·WONDER WEDGES (100) 13MM Med GREEN
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150591·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 200mm
INFINI RADIOFREQUENCY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BRESAGEN CATHETER, MODEL CS-3000
FDA 510(k)
FDA Class 2
·Neurology
E1 RINGLOC BIPOLAR 28X51MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·June 17, 2019
BIOMEX SHELL PC DIA48MM LN 22
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 2, 2015
ZIMMER TM REVERSE HUMERAL STEM SPACER
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code HSD·January 9, 2013
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·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