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Panels › Gastroenterology, Urology › Product code KNW · Class 2

Instrument, Biopsy

Regulation 876.1075

9510(k)s in 12 months (366 all time)
5recalls in 12 months (107 all time)
103recalls that name a 510(k)
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Top companies in KNW

Company510(k)sRecalls
Bard Peripheral Vascular828
Medical Device Technologies, Inc.157
Argon Medical Devices211
Remington Medical, Inc.49
C.R. Bard, Inc.110
Hologic, Inc.47
Medtronic Advanced Energy, LLC011
Gallini U.S., LLC100
Manan Medical Products, Inc.100
Daum Corp.90
DateFirm and productCodeLinked 510(k)
Sep 14, 2004Boston Scientific Corporation
Manual Biopsy Devices containing AIM system: Co-Axial Lung Biopsy Needle, 6 inch/15 cm, 22 gauge, Cat. #40-600, Material #M001406001 (5 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 P
Terminated		 KNWK840033
Sep 14, 2004Boston Scientific Corporation
Manual Biopsy Devices containing AIM system: Crown Biopsy Needle: 6 inch/15 cm, 22 gauge, Cat. #40-404, Material #M001404041 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasa
Terminated		 KNWK840033
Sep 14, 2004Boston Scientific Corporation
Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street
Terminated		 KNWK813462
Sep 14, 2004Boston Scientific Corporation
Manual Biopsy Devices containing AIM system: Chiba Needle, 6 inch/15 cm, 22 gauge, Catalog #40-102, Material #M001401021 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Stre
Terminated		 KNWK813462
Jul 29, 2003Boston Scientific Corporation
ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250
Terminated		 KNWK935814
Jun 12, 2003Cardinal Health
Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic
Terminated		 KNWK962907
Jun 12, 2003Sanarus Medical Inc
Sanarus brand Centrica Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack)
Terminated		 KNWK022879

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