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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
Decided510(k)Device and applicantCode
Oct 31, 2000K002546CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
CIVCO Medical Instruments Co., Inc.
KNW
May 1, 2000K001132BONE BIOPSY NEEDLE
Promex, Inc.
KNW
Apr 24, 2000K000612ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
Inrad
KNW
Apr 10, 2000K000135PRO.DUCT CATHETER, MODEL CTH03
Pro. Duct Health, Inc.
KNW
Jan 7, 2000K994272AUTOMATED CORE BIOPSY DEVICE
Promex, Inc.
KNW
Dec 27, 1999K99393615MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE
Imagyn Surgical
KNW
Dec 23, 1999K993342DUCPREP BREAST ASPIRATOR, MODEL PMPO2
Windy Hill Technology, Inc.
KNW
Dec 6, 1999K993435MANUAL BONE MARROW BIOPSY DEVICE
Promex, Inc.
KNW
Nov 18, 1999K99281311 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT
Ethicon Endo-Surgery, Inc.
KNW
Aug 17, 1999K991980MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,
Ethicon Endo-Surgery, Inc.
KNW
Aug 12, 1999K992499GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE
Gallini U.S., LLC
KNW
Jun 25, 1999K991366DAUM MRI/CONVENTIONAL BIOPSY KIT
Daum GmbH
KNW
Jun 9, 1999K983867FUJI CATHETER, MODEL CTH001
Windy Hill Technology, Inc.
KNW
Jun 4, 1999K983296AUTO SUTURE ABBI SYSTEM
United States Surgical, A Division of Tyco Healthc
KNW
May 20, 1999K990839TRU-CORE I REUSABLE BIOPSY INSTRUMENT
Medical Device Technologies, Inc.
KNW
May 19, 1999K990645GALLINI ATRA-CUT NEEDLE
Gallini U.S., LLC
KNW
May 17, 1999K990716GALLINI BYCUT NEEDLE
Gallini U.S., LLC
KNW
May 13, 1999K990515MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM
International Medical Systems
KNW
Apr 28, 1999K990782DAUM NEUROGATE TROCAR
Daum GmbH
KNW
Mar 30, 1999K990278DAUM NEUROCUT NEUROBIOPSYNEEDLE
Daum Corp.
KNW
Dec 10, 1998K983187MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE
Medsol Corp.
KNW
Sep 23, 1998K982960MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
Medical Device Technologies, Inc.
KNW
Sep 9, 1998K982735LIGHT SABER BONE BIOPSY NEEDLE
Minrad, Inc.
KNW
Sep 8, 1998K982401PROSTATE BIOPSY NEEDLE
Remington Medical, Inc.
KNW
Aug 5, 1998K981796LIGHT SABER CORE TISSUE NEEDLE
Minrad, Inc.
KNW
Jul 28, 1998K981721C0-AXIAL INTRODUCER NEEDLE
Inrad
KNW
Jul 17, 1998K982085MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT
Medical Device Technologies, Inc.
KNW
Jul 8, 1998K981301SPEED-CUT AUTOMATIC BIOPSY SYSTEM
Gallini U.S., LLC
KNW
Jul 7, 1998K972328PERCUTANEOUS BREAST BIOPSY (PBB)
Urothealth System, Inc.
KNW
Jun 29, 1998K981320DAUM BONE BIOPSY SET
Daum Corp.
KNW
Jun 22, 1998K981166ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214
Inrad
KNW
Jun 10, 1998K981477MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE
Medical Biopsy, Inc.
KNW
May 21, 1998K980676SPIGAL NEEDLE
Gallini U.S., LLC
KNW
May 6, 1998K980479QUICK-CUT AUTOMATIC BIOPSY SYSTEM
Gallini U.S., LLC
KNW
Mar 19, 1998K963794PUNCTURENEEDLE
Ferguson Medical
KNW
Mar 9, 1998K974631DAUM NEUROBIOPSY NEEDLE
Daum Corp.
KNW
Mar 6, 1998K974576DAUM BIOPSYGUN
Daum Corp.
KNW
Mar 6, 1998K974575DAUM ASPIRATIONBIOPSY NEEDLE
Daum Corp.
KNW
Mar 6, 1998K974574DAUM NEUROPUNCTURE NEEDLE
Daum Corp.
KNW
Feb 18, 1998K980452MANAN LIVER BIOPSY KIT
Medical Device Technologies, Inc.
KNW
Feb 18, 1998K980248ACRI R NEEDLE
Gallini U.S., LLC
KNW
Feb 18, 1998K980226MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM
Medical Device Technologies, Inc.
KNW
Feb 6, 1998K980211MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES
Manan Medical Products, Inc.
KNW
Feb 3, 1998K980196MD TECH BIOPSY SET FOR BONE AND BONE MARROW
Medical Device Technologies, Inc.
KNW
Jan 30, 1998K980122MANAN SOFT TISSUE BIOPSY NEEDLES
Medical Device Technologies, Inc.
KNW
Jan 30, 1998K974440IBI
Gallini U.S., LLC
KNW
Jan 23, 1998K980068WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE
Worldwide Medical Technologies, LLC
KNW
Jan 23, 1998K974794WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE
Worldwide Medical Technologies, LLC
KNW
Jan 21, 1998K974312REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR
Telemed Systems, Inc.
KNW
Jan 9, 1998K980004MANAN GENERAL PURPOSE INTRODUCER NEEDLE
Medical Device Technologies, Inc.
KNW

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