FDA.reportPublic FDA data

DAVCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
David Lennarz5N2026-01-01144 Research Drive Hampton VA US 23666
David Lennarz5N2026-01-01144 research drive Hampton VA US 23666
David Lennarz5N2026-01-01144 Research Drive Hampton VA US 23666
12136431213643DAVOL INC., SUB. C.R. BARD, INC.1N2026-01-01100 Crossings Blvd Warwick RI US 02886
12192141219214David Scott Company.1N2026-01-012 MASTER DR FRANKLIN MA US 02038
12230891000120505DAVOL INC.1N2026-01-01160 New Boston St WOBURN MA US 01801
30297791000523895DAVRYAN LABORATORIES, INC.1N2026-01-01844 Mirmar Dr Valparaiso IN US 46385
80102243004138471David Lennarz1N2026-01-01144 Research Drive Hampton VA US 23666
80200343008238542David Lennarz1N2026-01-01144 RESEARCH DRIVE Hampton VA US 23666
80205473008307751David Smith1N2026-01-011255 Schilling Blvd W Collierville TN US 38017
80218536005David Lennarz1N2026-01-01144 Research Drive Hampton VA US 23666
80218717116David Lennarz1N2026-01-01144 Research Drive Hampton VA US 23666
80230216423David Lennarz1N2026-01-01144 Research Drive Hampton VA US 23666
80230543004216185David Vu1N2026-01-0129 Parker Irvine CA US 92618
80303001000629909David Lennarz1N2026-01-01144 Research Drive HAMPTON VA US 23666
80306543004555163David Lennarz1N2026-01-01144 Research Dr Hampton VA US 23666
80309671000640985David Lennarz1N2026-01-01144 Research Dr Hampton VA US 23666
80310541000558210David Lennarz1N2026-01-01144 Research Drive Hampton VA US 23666
80390535639David Lennarz1N2026-01-01144 Research Drive Hampton VA US 23666
80403745864David Lennarz1N2026-01-01144 Research Drive HAMPTON VA US 23666
80404213008069071David Lennarz1N2026-01-01144 Research Drive HAMPTON VA US 23666
80433923007074101David Lennarz1N2026-01-01144 Research Dr Hampton VA US 23666
80437173003792251David Lin1N2026-01-011338 W Storm Pkwy STE D Torrance CA US 90501
80437253009631751David Lennarz1N2026-01-01144 Research Dr Hampton VA US 23666
80437343004203341David Lennarz1N2026-01-01144 Research Drive Hampton VA US 23666

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
360801751874277P800002AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEBLMF1980-10-24
360931751874277P800002AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEBLMF1980-10-24
360801530402033P150016TRIDYNE VASCULAR SEALANTNBE2016-04-11
360801406439525P050038ARISTA AH ABSORBABLE HEMOSTATLMG2006-09-26
360931406439525P050038ARISTA AH ABSORBABLE HEMOSTATLMG2006-09-26
360801740365303P010047PROGEL PLEURAL AIR LEAK SEALANTNBE2010-01-14
360801122010881N17600AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT)LMF1976-08-26
360931122010881N17600AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT)LMF1976-08-26
360801711109560K991799DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXOHIG1999-09-13
360801793560087K991637BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700FTL1999-06-22
360801696934137K984197FLUOROTEX SURGICAL MESHFTL1999-01-07
360801075778351K982867HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000HIG1999-02-19
360801772610270K980548DURA-PATCH MODEL DP-XXXGXQ1998-05-13
106621607553177K972883ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)FXX1998-02-26
106621413542731K972849ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)FXX1998-05-28
360801185004146K970078HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEMHIG1997-12-11
360801812637610K963141KUGEL HERNIA PATCHFTL1996-10-11
750761261587319K962374FIBER-SPLINT ML MULTILAYEREBI1996-07-22
360802065971817K961492HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010GCJ1996-05-15
360801987616638K961224HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEMGCJ1996-05-16
442961154431461K953939QUINTESTSCL1995-11-13
360801395807547K953577BARD VISILEX MESH 3 X 6FTL1995-09-26
502101724553807K952465PROBE PERSONAL LUBRICANT - SILKY LIGHTHIS1995-11-22
502101106951476K952464PROBE PERSONAL LUBRICANT - CLASSICHIS1995-11-22
360801639513359K951086NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM AND ACCESSORIESGCJ1995-03-16
360801993229416K951026DAVOL ARTHRO-FLO 3HRX1995-06-02
360801544703751K946089NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AND WITHOUT PUNCTURE CANNULAGCJ1995-03-06
360801764364668K945317NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIESGEI1995-02-01
360801552965357K942886SIMPULSE SOLO SUCTION IRRIGATORFQH1994-07-19
360801715211912K941334DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBEHET1994-06-14
360801739938545K935503DAVOL LAPAROSCOPIC INSUFFLATION TUBING SETHIF1994-03-07
360801633967069K922916BARD MARLEX MESH DARTFTL1992-08-24
360801173262459K921716DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEMHET1993-11-08
360801880911280K914526DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY)GCJ1991-11-22
360801952380650K914119DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEMCAC1992-12-03
360801964395749K913999NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBEGCJ1991-11-01
360802012134402K913944NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIESHET1992-03-09
360801742480917K913247SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEMCAC1993-02-25
360801670189279K913028ARTHRO-FLOW IRRIGATION 2 SYSTEMHRX1991-10-10
360801846661452K911274UNIPOLAR COAGULATOR PROBE SYSTEMGEI1991-06-20
360802043185362K902722BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEMHET1990-11-16
360801194965168K896118NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USEHET1990-03-28
360801603224351K894990DAVOL ARTHROSCOPY CANNULAHRX1989-11-08
360801410884521K870915SIMPULSE ARTHROSCOPY IRRIGATION SYSTEMHRX1987-04-01
360801184746000K830386DAVOL SURGICAL SUCTION IRRIGATION INSTRFQH1983-03-29
750761528197960K790555HEMO-WEDGEDZN1980-01-17
360802024220708K251557Bard® Mesh; Bard® Mesh Pre-ShapedFTL2025-06-12
360801931988259K250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedFTL2025-04-09
360801810473647K243241Phasix ST Umbilical Hernia PatchOWT2025-02-19
360802048629884K2412503DMax Light MeshFTL2024-06-14
360801204923851K233999GalaFLEX LITE ScaffoldOOD2024-04-09
360801563529954K233402Bard 3DMax MeshFTL2023-11-01
107971374250126K233398Faros Surgical SystemHQC2024-06-27
128212031160264K201177RadGil2MOT2020-08-17
360801777884253K2008183DMax MID Anatomical MeshFTL2020-07-17
360801599353124K191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 FastenersGDW2019-07-16
360801282431785K190185Phasix ST Mesh with Open Positioning SystemOWT2019-06-12
360801550026144K182008Phasix ST Mesh with Echo 2 Positioning SystemFTL2018-12-14
360801844229215K173143Phasix ST MeshOWT2018-04-25
360801869109950K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) OvalFTL2017-05-01
360801234366676K163698OptiFix Open Absorbable Fixation System - 20 absorbable fastenersGDW2017-04-11
360802045600072K162922GalaFORM 3DOOD2017-02-23
360801037138987K162193XenMatrix AB Surgical GraftPIJ2016-12-23
360801562878235K161424Phasix MeshOOD2016-09-29
360931562878235K161424Phasix MeshOOD2016-09-29
360801476572322K161092GalaSHAPE 3DOOD2016-08-23
360801208161874K160900CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fastenersGDW2016-05-31
360802066322745K151177XenMatrix AB Surgical GraftPIJ2015-07-30
360801451532857K143380Phasix ST MeshOWT2015-06-05
360931451532857K143380Phasix ST MeshOWT2015-06-05
360801438642181K142873OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fastenersGDW2015-03-12
360801870097065K142818Phasix MeshOOD2015-03-31
360931870097065K142818Phasix MeshOOD2015-03-31
360801305604715K142808CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fastenersGDW2015-03-09
360801886923577K142711ONFLEX MeshFTL2015-03-20
360801837618884K142706Modified ONFLEX MeshFTL2015-03-25
442811105336423K142027888 WNLE POWERED WHEELCHAIRITI2014-10-07
360801371101384K140533GALAFLEX MESHOOD2014-05-21
360801729549758K140501XENMATRIX SURGICAL GRAFTFTM2014-04-28
107971682207982K133562CATARHEX 3HQC2014-08-12
360801013046758K133223XENMATRIX AB SURGICAL GRAFTPIJ2014-09-19
360801222623587K132441BARD VENTRALEX HERNIA PATCHFTL2013-12-13
360801718671558K130968VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEMFTL2013-05-01
360801389078595K122436COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEMFTL2012-11-02
360801212652964K120728PHASIX PLUG AND PATCHOWT2012-10-22
360931212652964K120728PHASIX PLUG AND PATCHOWT2012-10-22
360801881070827K111153SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEMGDW2011-05-24
360801634929799K110820VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEMFTL2011-04-01
360801366938927K102766COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEMFTL2010-12-16
360801252258738K101928VENTRALEX ST HERNIA PATCHFTL2011-03-23
360801081439100K101920VENTRIO ST HERNIA PATCHFTL2011-03-23
360801453849783K101851VENTRALIGHT ST MESHFTL2010-07-15
360801634879936K100229VENTRIO HERNIA PATCHFTL2010-04-21
360801827079434K092032BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160FTL2009-12-08
360801148094231K091659BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732FTL2009-08-03
415751744009807K083724WIENER LAB. URINE STRIP 10 AND 11JIO2009-09-02
360801310693339K082687COLLAMEND FM IMPLANTFTM2008-10-17
360931310693339K082687COLLAMEND FM IMPLANTFTM2008-10-17
360801467779788K081272PORCINE SURGICAL MESH; DERMAL MATRIXFTM2008-07-31
360801769198429K081010BARD 3DMAX MESHFTL2008-10-07
360801933310477K063739SEPRAMESH, MODEL 5959-1214FTL2007-01-17
360801831544907K061754BARD COMPOSITE L/P MESHFTL2006-10-23
360801569900015K053066SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESHFTL2005-12-19
360801207275390K052155BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPEDFTL2005-10-20
360801140231836K042026BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004FTL2004-09-10
360801227200643K041641DAVOL DELIVERY SYSTEMGCJ2004-07-01
360801986428847K040868SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESHFTM2004-06-04
360801599984093K033666HEMADERMQSY2003-12-17
360931599984093K033666HEMADERMQSY2003-12-17
429031749848145K032133BRODA MODEL 587 MANUAL WHEELCHAIRIOR2003-07-21
360801358046372K031213AQUASENS FLUID MONITORING SYSTEMHIG2003-04-30
415751970932824K030482WIENER LAB. STANDATROL S-E 2 NIVELES, LOVELS 1&2: 3X5 ML VIALS CAT.NR.1937553JJY2003-03-19
415751822373711K024305WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006JIX2003-03-18
415751833676965K024116WIENER LAB. BILIRUBINA DIRECT AACIG2003-02-12
360801275303674K024008SMALL BARD VENTRALEX PATCHFTL2003-02-20
415751256002077K023992WIENER LAB COLINESTERASA AADIH2003-02-12
415751145204733K023889WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254MIU2004-02-11
415751891323320K023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354JHW2003-01-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FTL392025-06-12
OOD82024-04-09
GCJ82004-07-01
OWT72025-02-19
GDW62019-07-16
FTM52014-04-28
HET51994-06-14
HIG42003-04-30
GEI42001-02-28
HRX41995-06-02
LMF41980-10-24
PIJ32016-12-23
ITI32014-10-07
INI32002-01-28
HQC22024-06-27
NBE22016-04-11
LMG22006-09-26
QSY22003-12-17
IOR22003-07-21
CIG22003-02-12
JFJ22002-12-09
CIT22002-12-09
KNK22002-12-09
FXX21998-05-28
HIS21995-11-22
FQH21994-07-19
CAC21993-02-25
MOT12020-08-17
JIO12009-09-02
MIU12004-02-11
JJY12003-03-19
JIX12003-03-18
DIH12003-02-12
JHW12003-01-03
CJY12002-09-10
CGS12002-07-03
CJE12002-01-28
CIC12001-12-21
CGA12001-12-21
CEO12001-11-16

NDC#

PMA#

127 records. Showing 1-40. Next

PMN#

168 records. Showing 1-40. Next

Applications#

76 records. Showing 1-40. Next