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362 FDA 510(k) clearances · Product code

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RecordFirmDate
AUTOMATED CORE BIOPSY DEVICE (K994272)Promex, Inc.2000-01-07
15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE (K993936)Imagyn Surgical1999-12-27
DUCPREP BREAST ASPIRATOR, MODEL PMPO2 (K993342)Windy Hill Technology, Inc.1999-12-23
MANUAL BONE MARROW BIOPSY DEVICE (K993435)Promex, Inc.1999-12-06
11 GAUGE PROBE, STEREOTACTIC, 14 GAUGE PROBE, STEREOTACTIC,14 GAUGE PROBE, ULTRASOUND, HOUSING STEREOTACTIC,HOUSING, ULT (K992813)Ethicon Endo-Surgery, Inc.1999-11-18
MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH, (K991980)Ethicon Endo-Surgery, Inc.1999-08-17
GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE (K992499)Gallini U.S., LLC1999-08-12
DAUM MRI/CONVENTIONAL BIOPSY KIT (K991366)Daum GmbH1999-06-25
FUJI CATHETER, MODEL CTH001 (K983867)Windy Hill Technology, Inc.1999-06-09
AUTO SUTURE ABBI SYSTEM (K983296)United States Surgical, A Division of Tyco Healthc1999-06-04
TRU-CORE I REUSABLE BIOPSY INSTRUMENT (K990839)Medical Device Technologies, Inc.1999-05-20
GALLINI ATRA-CUT NEEDLE (K990645)Gallini U.S., LLC1999-05-19
GALLINI BYCUT NEEDLE (K990716)Gallini U.S., LLC1999-05-17
MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM (K990515)International Medical Systems1999-05-13
DAUM NEUROGATE TROCAR (K990782)Daum GmbH1999-04-28
DAUM NEUROCUT NEUROBIOPSYNEEDLE (K990278)Daum Corp.1999-03-30
MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE (K983187)Medsol Corp.1998-12-10
MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT (K982960)Medical Device Technologies, Inc.1998-09-23
LIGHT SABER BONE BIOPSY NEEDLE (K982735)Minrad, Inc.1998-09-09
PROSTATE BIOPSY NEEDLE (K982401)Remington Medical, Inc.1998-09-08
LIGHT SABER CORE TISSUE NEEDLE (K981796)Minrad, Inc.1998-08-05
C0-AXIAL INTRODUCER NEEDLE (K981721)Inrad1998-07-28
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT (K982085)Medical Device Technologies, Inc.1998-07-17
SPEED-CUT AUTOMATIC BIOPSY SYSTEM (K981301)Gallini U.S., LLC1998-07-08
PERCUTANEOUS BREAST BIOPSY (PBB) (K972328)Urothealth System, Inc.1998-07-07
DAUM BONE BIOPSY SET (K981320)Daum Corp.1998-06-29
ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 (K981166)Inrad1998-06-22
MEDICAL BIOPSY AUTOMATIC CUTTING NEEDLE (K981477)Medical Biopsy, Inc.1998-06-10
SPIGAL NEEDLE (K980676)Gallini U.S., LLC1998-05-21
QUICK-CUT AUTOMATIC BIOPSY SYSTEM (K980479)Gallini U.S., LLC1998-05-06
PUNCTURENEEDLE (K963794)Ferguson Medical1998-03-19
DAUM NEUROBIOPSY NEEDLE (K974631)Daum Corp.1998-03-09
DAUM BIOPSYGUN (K974576)Daum Corp.1998-03-06
DAUM NEUROPUNCTURE NEEDLE (K974574)Daum Corp.1998-03-06
DAUM ASPIRATIONBIOPSY NEEDLE (K974575)Daum Corp.1998-03-06
ACRI R NEEDLE (K980248)Gallini U.S., LLC1998-02-18
MANAN LIVER BIOPSY KIT (K980452)Medical Device Technologies, Inc.1998-02-18
MANAN PRO-MAG AUTOMATIC BIOPSY SYSTEM (K980226)Medical Device Technologies, Inc.1998-02-18
MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES (K980211)Manan Medical Products, Inc.1998-02-06
MD TECH BIOPSY SET FOR BONE AND BONE MARROW (K980196)Medical Device Technologies, Inc.1998-02-03
MANAN SOFT TISSUE BIOPSY NEEDLES (K980122)Medical Device Technologies, Inc.1998-01-30
IBI (K974440)Gallini U.S., LLC1998-01-30
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY NEEDLE (K974794)Worldwide Medical Technologies, LLC1998-01-23
WORLDWIDE MEDICAL TECHNOLOGIES I TYPE NEEDLE (K980068)Worldwide Medical Technologies, LLC1998-01-23
REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR (K974312)Telemed Systems, Inc.1998-01-21
GALLINI ABS DEVICE (K973152)Gallini U.S., LLC1998-01-09
MANAN GENERAL PURPOSE INTRODUCER NEEDLE (K980004)Medical Device Technologies, Inc.1998-01-09
MANAN(TM) SUPER-CORE BIOPSY NEEDLES (K974814)Medical Device Technologies, Inc.1998-01-09
MANAN AUTOMATIC CUTTING NEEDLE (K974446)Manan Medical Products, Inc.1998-01-08
MANAN TECHNA-CUT ASPIRATION NEEDLE (K974766)Medical Device Technologies, Inc.1998-01-08
PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER (K972496)Tao & Tao Technologyt, Inc.1997-12-09
ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY (K974158)Ortho Development Corp.1997-12-09
THE AUTO SUTURE* MIBB** SYSTEM (K973496)United States Surgical, A Division of Tyco Healthc1997-12-01
STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM (K973215)Laurus Medical Corp.1997-11-06
QUICK-CARE BIOPSY NEEDLE (K973565)Cook, Inc.1997-11-03
MRI COMPATIBLE BIOPSY NEEDLES (K962977)Manan Medical Products, Inc.1997-10-09
GALLINI COAXIAL INTRODUCER (K972266)Gallini U.S., LLC1997-07-29
PAN (CHIBA ASPIRATING NEEDLE) (K970872)Gallini Intl., Inc.1997-05-21
TR NEEDLE (K970871)Gallini Intl., Inc.1997-05-21
MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME) (K970565)Biopsys Medical, Inc.1997-03-28
SURE CORE BIOPSY KIT (K963813)Interventional Concepts, Inc.1997-03-20
TZ (K964777)Gallini Intl., Inc.1997-01-03
AUTO SUTURE* ABBI* SYSTEM (K963825)United States Surgical, A Division of Tyco Healthc1996-12-20
MEDICAL DEVICE TECHNOLOGIES, INC.ULTRA (K962969)Medical Device Technologies, Inc.1996-12-06
SPEED-CUT (K961407)Gallini Intl., Inc.1996-11-21
SKINNY,FRANSEEN,WESCOTT NEEDLES (K962907)Baxter Healthcare Corp1996-10-23
BIOPSY INTRODUCER NEEDLE (K963390)Baxter Healthcare Corp1996-10-10
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER (K962077)C.R. Bard, Inc.1996-07-30
TEMNO DOUBLE SHOT BIOPSY NEEDLE (K960065)Bauer Medical, Inc.1996-04-05
TEMNO ACHIEVE BIOPSY NEEDLE (K960064)Bauer Medical, Inc.1996-04-05
18 GAUGE TRU-CUT BIOPSY NEEDLE (K960509)Baxter Healthcare Corp1996-04-04
LILY MULTICANNULA GUIDE (K954999)Lily Imaging Solutions Co.1996-04-04
AUTOMATED TRU-CUT BIOPSY DEVICE (K954529)Baxter Healthcare Corp1995-12-29
NEEDLE OR CUTTER (K953399)Biophysic Medical, Inc.1995-10-30
TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLE (K954265)Promex, Inc.1995-09-29
BIOACCESS BONE BIOPSY SYSTEM (K954151)Bioaccess, Inc.1995-09-15
URESIL INTRODUCING NEEDLE (K953923)Uresil Corp.1995-09-08
BIOPSY NEEDLE (K953880)Biopsys Medical, Inc.1995-09-08
MODIFIED BIOPSY NEEDLE (K951229)Biopsys Medical, Inc.1995-04-06
MANAN SUPER-CORE BIOPSY NEEDLE (K950732)Manan Medical Products, Inc.1995-03-02
BIOPSY DEVICE ACCESSORY (K945573)Biopsys Medical, Inc.1994-12-09
MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE (K944837)Medical Device Technologies, Inc.1994-10-14
TECHNA-CUT ASPIRATION NEEDLE (K943651)Manan Medical Products, Inc.1994-09-29
LIVER BIOPSY KIT (K943650)Manan Medical Products, Inc.1994-08-26
TRU-CORE NEEDLE SET (K943368)Ideamatrix1994-07-29
QUICK CORE II (K941256)Proact, Ltd.1994-07-13
WANG/MILL-ROSE PLEURAL BIOPSY NEEDLE (K942630)Mill-Rose Laboratory1994-07-12
BIOPSY NEEDLE AND HOUSING (K942639)Biopsys Medical, Inc.1994-07-07
BIP MULTI MODIFICATION (K934371)Bip USA, Inc.1994-04-28
BIOPSY NEEDLE AND HOUSING (K941549)Biopsys Medical, Inc.1994-04-19
MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE (K935814)Boston Scientific Corp1994-03-14
MANAN ADAPTER FOR BARD BIOPTY SYSTEM (K940365)Manan Medical Products, Inc.1994-02-25
MANAN ADAPTER FOR BIP BIOPSY DEVICE (K933448)Manan Medical Products, Inc.1993-11-12
ACECUT SUTOMATIC BIOPSY SYSTEM (K930201)Meadox Surgimed, Inc.1993-06-09
EMS BIOPSY INSTRUMENT (K930083)Engineered Medical Systems1993-04-21
OLYMPUS DISPOSABLE BIOPSY FORCEPS (K930241)Olympus Corp.1993-04-20
BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT. (K922939)C.R. Bard, Inc.1993-02-16
BIOPSY FORCEPS (K924106)United States Endoscopy Group, Inc.1992-11-24
GRICE SOFT TISSUE BIOPSY KIT (K922161)Ideal Medical, Inc.1992-10-13
MEADOX SURGIMED BIOPSY GUN III (K922879)Meadox Medicals, Div. Boston Scientific Corp.1992-09-01
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