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

Instrument, Biopsy

Regulation 876.1075

8510(k)s in 12 months (365 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
Decided510(k)Device and applicantCode
Feb 28, 2014K133702PRESTO BREAST BIOPSY DEVICE
Sontina Medical, LLC
KNW
Feb 21, 2014K133948BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT
Bard Peripheral Vascular, Inc.
KNW
Feb 7, 2014K130616MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES
Biopsybell S.R.L.
KNW
Oct 22, 2013K131157RANFAC BONE MARROW ASPIRATION NEEDLE
Ranfac, Corp.
KNW
May 13, 2013K130282REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
Remington Medical, Inc.
KNW
Mar 1, 2013K123606CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE
Scion Medical Technologies, LLC
KNW
Nov 15, 2012K123259MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
Devicor Medical Products, Inc.
KNW
Aug 22, 2012K121181SWANNSHIDI BONE MARROW ASPIRATION NEEDLE
Alliance Partners, LLC
KNW
Jun 26, 2012K120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE
Busse Hospital Disposables, Inc.
KNW
May 17, 2012K120440PRESTO BREAST BIOPSY DEVICE
Sontina Medical, LLC
KNW
Mar 20, 2012K112411MAMMOTOME ELITE BIOPSY SYSTEM
Devicor Medical Products, Inc.
KNW
Mar 8, 2012K113872THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
Vidacare Corporation
KNW
Feb 22, 2012K120189BONETRAP
Berni Farns Incorporated
KNW
Nov 29, 2011K102756SURECORE BIOPSY DEVICE
Chest Innovations, Inc.
KNW
Nov 21, 2011K113209CHIBA SONO
Pajunk GmbH, DE
KNW
Nov 3, 2011K112945ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
Inrad, Inc.
KNW
Oct 20, 2011K112468THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
Regulatory Specialists, Inc.
KNW
Sep 6, 2011K111765FULL CORE BIOPSY SYSTEM
Promex Technologies, LLC
KNW
Jul 29, 2011K111529MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN-
Insert Molding Solutions, Inc.
KNW
Jun 24, 2011K102771BIOPSY HANDY, MRI BIOPSY HANDY
Somatex Medical Technologies GmbH
KNW
Jun 16, 2011K111100ENCOR ENSPIRE BREAST BIOPSY SYSTEM
C.R. Bard, Inc.
KNW
Jun 8, 2011K110883J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
Busse Hospital Disposables
KNW
May 27, 2011K092338MEDAX UNIPERSONALE SRL
Medax Unipersonale Srl
KNW
Dec 27, 2010K103359FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
C.R. Bard, Inc.
KNW
Aug 27, 2010K101832BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
Medical Device Technologies, Inc.
KNW
Apr 29, 2010K093899MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING
Ethicon Endo-Surgery, LLC
KNW
Nov 20, 2009K093512ENCOR BREAST BIOPSY SYSTEM
Senorx, Inc.
KNW
Nov 19, 2009K093399PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520
Inrad
KNW
Nov 17, 2009K093256SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
Inrad
KNW
Nov 10, 2009K093068FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US
C.R. Bard, Inc.
KNW
Sep 24, 2009K092059RP CUTTING NEEDLE
Riverpoint Medical
KNW
Jun 4, 2009K090611REVOLUTION FULL CORE BIOPSY
Inrad
KNW
Oct 15, 2008K082681VACORA VACUUM ASSISTED BIOPSY SYSTEM
C.R. Bard, Inc.
KNW
Jun 17, 2008K081057INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL
Intact Medical Corporation
KNW
Apr 11, 2008K080095CORAMATE/SPIROTOME SYSTEM
Medinvents, BE
KNW
Mar 6, 2008K080171SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
Sanarus Medical, Inc.
KNW
Oct 22, 2007K072045ONCONTROL BONE MARROW BIOPSY SYSTEM
Vidacare Corporation
KNW
Oct 16, 2007K071814LIGHT SABRE SPINAL ACCESS DEVICE
Minrad, Inc.
KNW
May 15, 2007K071048RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537
Rubicor Medical, Inc.
KNW
Apr 30, 2007K063233DELTACUT (APPARATUS AND CANNULA)
PAJUNK GmbH Medizintechnologie, DE
KNW
Apr 18, 2007K070091COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208
Cardinal Health, Inc.
KNW
Feb 14, 2007K063697SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT
PAJUNK GmbH Medizintechnologie, DE
KNW
Oct 20, 2006K062832VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
C.R. Bard, Inc.
KNW
Jul 13, 2006K060384CORAMATE/SPIROTOME SYSTEM
Medinvents, BE
KNW
Jul 3, 2006K061570I-STYLE BONE MARROW ASPIRATION NEEDLE
Busse Hospital Disposables, Inc.
KNW
Apr 27, 2006K060413INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE
Intact Medical Corporation
KNW
Nov 18, 2005K053151RUBICOR MAGIC BREAST BIOPSY DEVICE
Rubicor Medical, Inc.
KNW
Nov 7, 2005K052638ABBOTT SPINE, INC. SPINNAKER SYSTEM
Abbott Spine, Inc.
KNW
Nov 3, 2005K052435PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS
Pneumrx, Inc.
KNW
Nov 1, 2005K052802MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
Manan Medical Products, Inc.
KNW

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