Avitene Microfibrillar Collagen Hemostat
C.R. Bard, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1018233 | 1018233 | C.R. BARD, INC. | 1 | Y | 2026-01-01 | 8195 INDUSTRIAL BLVD. COVINGTON GA US 30014 |
| 1313046 | 1313046 | C.R. BARD, INC. | 1 | N | 2026-01-01 | 289 Bay Rd Queensbury NY US 12804 |
| 3006082230 | 3006082230 | C.R. BARD, INC. | 1 | N | 2026-01-01 | 1211 MARY MAGNAN BLVD. MADISON GA US 30650 |
| 1030583 | 1030583 | C.R. BARD, INC. | 1 | N | 2020-04-25 | 428 POWERHOUSE RD. MONCKS CORNER SC US 29461 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 36072 | 1959520641 | P900030 | CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT | LNM | 1993-09-30 |
| 6288 | 1959520641 | P900030 | CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT | LNM | 1993-09-30 |
| 6288 | 1979670699 | P060002 | FLAIR ENDOVASCULAR STENT GRAFT | PFV | 2007-07-23 |
| 36072 | 1979670699 | P060002 | FLAIR ENDOVASCULAR STENT GRAFT | PFV | 2007-07-23 |
| 36072 | 1909626595 | K993840 | BARD UROFORCE BALLOON DILATION CATHETER | EZN | 2000-01-31 |
| 36072 | 1384859120 | K993464 | BARDEX I.C. PEDIATRIC FOLEY CATHETER | MJC | 1999-12-10 |
| 36073 | 1384859120 | K993464 | BARDEX I.C. PEDIATRIC FOLEY CATHETER | MJC | 1999-12-10 |
| 36079 | 1274882415 | K993000 | BARD HYDROPHILIC COATED GUIDE WIRES | DQX | 1999-11-02 |
| 36072 | 1274882415 | K993000 | BARD HYDROPHILIC COATED GUIDE WIRES | DQX | 1999-11-02 |
| 6288 | 1274882415 | K993000 | BARD HYDROPHILIC COATED GUIDE WIRES | DQX | 1999-11-02 |
| 6288 | 1793560087 | K991637 | BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 | FTL | 1999-06-22 |
| 36072 | 1793560087 | K991637 | BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 | FTL | 1999-06-22 |
| 36072 | 1406886467 | K991280 | 125 IMPLANT SEEDS, MODEL STM1251 | KXK | 1999-10-20 |
| 36073 | 1962823976 | K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER | MJC | 1999-02-16 |
| 36072 | 1962823976 | K984136 | BARDEX LUBRI-SIL I.C. FOLEY CATHETER | MJC | 1999-02-16 |
| 36073 | 1204601683 | K984084 | BARDEX LUBRI-SIL FOLEY CATHETER | EZL | 1999-02-01 |
| 36072 | 1204601683 | K984084 | BARDEX LUBRI-SIL FOLEY CATHETER | EZL | 1999-02-01 |
| 36072 | 1440072784 | K983498 | BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE | FAD | 1998-12-15 |
| 36073 | 1931457559 | K983101 | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 | MJC | 1998-11-03 |
| 36072 | 1931457559 | K983101 | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 | MJC | 1998-11-03 |
| 36072 | 1156629858 | K983064 | IMPRA HIGH POROSITY GRAFT | DSY | 1998-11-19 |
| 36072 | 2011477985 | K972152 | DEVMED STEPPING AND STABILIZING SYSTEM | ITX | 1997-08-15 |
| 36072 | 1325987720 | K962538 | BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06) | FAS | 1996-12-17 |
| 36072 | 1333831824 | K962077 | BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER | KNW | 1996-07-30 |
| 6288 | 1333831824 | K962077 | BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER | KNW | 1996-07-30 |
| 36072 | 1182511412 | K961841 | BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) | FAS | 1996-10-09 |
| 6288 | 2065971817 | K961492 | HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 | GCJ | 1996-05-15 |
| 36072 | 2065971817 | K961492 | HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010 | GCJ | 1996-05-15 |
| 36072 | 1920276970 | K961248 | BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS | FFL | 1996-05-28 |
| 6288 | 1920276970 | K961248 | BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS | FFL | 1996-05-28 |
| 36072 | 2035947347 | K960176 | DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER | FEG | 1996-07-24 |
| 36072 | 1564892839 | K955712 | USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING | LDF | 1996-10-11 |
| 6288 | 1395807547 | K953577 | BARD VISILEX MESH 3 X 6 | FTL | 1995-09-26 |
| 36072 | 1395807547 | K953577 | BARD VISILEX MESH 3 X 6 | FTL | 1995-09-26 |
| 6288 | 1999107005 | K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | GBX | 1995-05-15 |
| 36072 | 1999107005 | K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | GBX | 1995-05-15 |
| 36079 | 1999107005 | K951907 | NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER | GBX | 1995-05-15 |
| 36072 | 1578428099 | K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER | GBX | 1995-04-24 |
| 36079 | 1578428099 | K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER | GBX | 1995-04-24 |
| 6288 | 1578428099 | K951475 | NAVARRE UNIVERSAL DRAINAGE CATHETER | GBX | 1995-04-24 |
| 36072 | 1308305285 | K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT | KOD | 1995-09-27 |
| 6288 | 1308305285 | K951260 | URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT | KOD | 1995-09-27 |
| 36072 | 2025653400 | K951103 | SILASTIC BRAND FOLEY CATHETER | EZL | 1995-04-28 |
| 36073 | 2025653400 | K951103 | SILASTIC BRAND FOLEY CATHETER | EZL | 1995-04-28 |
| 6288 | 1951885520 | K950300 | BARD FLEXIBLE TIP URETERAL CATHETER | EYB | 1995-04-27 |
| 36072 | 1951885520 | K950300 | BARD FLEXIBLE TIP URETERAL CATHETER | EYB | 1995-04-27 |
| 36073 | 1338910207 | K946249 | BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES | KNT | 1995-12-11 |
| 36072 | 1338910207 | K946249 | BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES | KNT | 1995-12-11 |
| 36072 | 1340342360 | K946249 | BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES | KNT | 1995-12-11 |
| 6288 | 1340342360 | K946249 | BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES | KNT | 1995-12-11 |
| 36072 | 1738024427 | K945753 | FST FIBEROPTIC PRESSURE CONVERTER | FEN | 1995-05-11 |
| 6288 | 1158469301 | K945495 | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | EXY | 1995-02-09 |
| 36072 | 1158469301 | K945495 | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | EXY | 1995-02-09 |
| 36079 | 1158469301 | K945495 | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | EXY | 1995-02-09 |
| 36072 | 1552965357 | K942886 | SIMPULSE SOLO SUCTION IRRIGATOR | FQH | 1994-07-19 |
| 6288 | 1552965357 | K942886 | SIMPULSE SOLO SUCTION IRRIGATOR | FQH | 1994-07-19 |
| 36072 | 1147023780 | K942315 | NAVARRE PERCUTANEOUS ACCESS SET | KGZ | 1994-07-08 |
| 6288 | 1147023780 | K942315 | NAVARRE PERCUTANEOUS ACCESS SET | KGZ | 1994-07-08 |
| 6288 | 1715211912 | K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | HET | 1994-06-14 |
| 36072 | 1715211912 | K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | HET | 1994-06-14 |
| 36072 | 1542819960 | K933600 | NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS | GBX | 1994-03-28 |
| 6288 | 1542819960 | K933600 | NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS | GBX | 1994-03-28 |
| 36072 | 1884414672 | K926088 | FST CATH UD-DUAL DUAL PRESSURE CATHETER | FEN | 1993-06-18 |
| 36079 | 1884414672 | K926088 | FST CATH UD-DUAL DUAL PRESSURE CATHETER | FEN | 1993-06-18 |
| 6288 | 1948755373 | K925446 | BARD SAFE SAMPLING DEVICE | FMI | 1993-07-29 |
| 36072 | 1948755373 | K925446 | BARD SAFE SAMPLING DEVICE | FMI | 1993-07-29 |
| 36072 | 1608495067 | K924714 | BARD URODYNAMIC CATHETER | FEN | 1993-09-21 |
| 36072 | 1633967069 | K922916 | BARD MARLEX MESH DART | FTL | 1992-08-24 |
| 6288 | 1633967069 | K922916 | BARD MARLEX MESH DART | FTL | 1992-08-24 |
| 36073 | 1799154326 | K922431 | BARD LATEX URINARY CATHETERS | KOD | 1993-03-25 |
| 36072 | 1799154326 | K922431 | BARD LATEX URINARY CATHETERS | KOD | 1993-03-25 |
| 36072 | 1173262459 | K921716 | DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM | HET | 1993-11-08 |
| 6288 | 1173262459 | K921716 | DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM | HET | 1993-11-08 |
| 6288 | 1529270858 | K915841 | BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC | KNT | 1993-06-25 |
| 36072 | 1529270858 | K915841 | BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC | KNT | 1993-06-25 |
| 6288 | 1596782597 | K915837 | NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM | KNT | 1993-03-23 |
| 36072 | 1596782597 | K915837 | NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM | KNT | 1993-03-23 |
| 6288 | 1446799131 | K915801 | BIP-COAX-SYSTEM | FCG | 1994-03-11 |
| 36072 | 1446799131 | K915801 | BIP-COAX-SYSTEM | FCG | 1994-03-11 |
| 6288 | 1880911280 | K914526 | DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY) | GCJ | 1991-11-22 |
| 36072 | 1880911280 | K914526 | DAVOL ENDO-FLO SUCT/IRRI PROBE (FOR GEN SURGERY) | GCJ | 1991-11-22 |
| 6288 | 1952380650 | K914119 | DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM | CAC | 1992-12-03 |
| 36072 | 1952380650 | K914119 | DAVOL ORTHOPAEDIC AUTOTRANSFUSION SYSTEM | CAC | 1992-12-03 |
| 6288 | 2012134402 | K913944 | NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES | HET | 1992-03-09 |
| 36072 | 2012134402 | K913944 | NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES | HET | 1992-03-09 |
| 36072 | 1840529431 | K913341 | BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER | EZC | 1992-01-27 |
| 36073 | 1840529431 | K913341 | BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER | EZC | 1992-01-27 |
| 6288 | 1742480917 | K913247 | SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM | CAC | 1993-02-25 |
| 36072 | 1742480917 | K913247 | SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM | CAC | 1993-02-25 |
| 6288 | 1603805262 | K913113 | FST CATH-UD CATHETER, MODIFICATION | FEN | 1991-10-09 |
| 36072 | 1603805262 | K913113 | FST CATH-UD CATHETER, MODIFICATION | FEN | 1991-10-09 |
| 36073 | 1530419612 | K910846 | BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF | EZC | 1991-08-16 |
| 36072 | 1530419612 | K910846 | BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF | EZC | 1991-08-16 |
| 36072 | 1358065650 | K910653 | TOUCHLESS II INTERMITTENT CATHETER | FCM | 1991-05-06 |
| 36073 | 1551136007 | K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER | MJC | 1994-08-18 |
| 36072 | 1551136007 | K910318 | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER | MJC | 1994-08-18 |
| 36072 | 1637565091 | K910197 | HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS | EZC | 1991-08-09 |
| 36073 | 1637565091 | K910197 | HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS | EZC | 1991-08-09 |
| 6288 | 1605708002 | K910196 | BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS | FGH | 1991-03-27 |
| 36072 | 1605708002 | K910196 | BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS | FGH | 1991-03-27 |
| 36073 | 1605708002 | K910196 | BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS | FGH | 1991-03-27 |
| 36072 | 1153162060 | K910195 | BARD HYDROGEL-COATED FOLEY CATHETERS | EZC | 1991-08-09 |
| 36073 | 1153162060 | K910195 | BARD HYDROGEL-COATED FOLEY CATHETERS | EZC | 1991-08-09 |
| 36072 | 1054368509 | K905641 | FST CATH-UD CATHETER | FEN | 1991-02-19 |
| 6288 | 1054368509 | K905641 | FST CATH-UD CATHETER | FEN | 1991-02-19 |
| 36072 | 1827026526 | K905102 | BARD(R) SYRINGE ASSIST IRRIGATION | OCX | 1991-04-09 |
| 36072 | 1405464196 | K904779 | BUTTON REPLACEMENT GASTROSTOMY DEVICE | KGC | 1991-01-18 |
| 6288 | 1405464196 | K904779 | BUTTON REPLACEMENT GASTROSTOMY DEVICE | KGC | 1991-01-18 |
| 36072 | 1382889968 | K903345 | BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE | FAD | 1991-04-30 |
| 36072 | 2043185362 | K902722 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM | HET | 1990-11-16 |
| 6288 | 2043185362 | K902722 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM | HET | 1990-11-16 |
| 6288 | 1787216037 | K896058 | GRASPING FORCEPS | KOA | 1989-12-28 |
| 36072 | 1787216037 | K896058 | GRASPING FORCEPS | KOA | 1989-12-28 |
| 36072 | 1274743694 | K881743 | VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER | LFJ | 1988-06-23 |
| 6288 | 1274743694 | K881743 | VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER | LFJ | 1988-06-23 |
| 6288 | 1494092634 | K880571 | CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM | LJT | 1988-03-04 |
| 36072 | 1494092634 | K880571 | CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEM | LJT | 1988-03-04 |
| 6288 | 1573255441 | K871488 | VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH | LFJ | 1987-06-12 |
| 36072 | 1573255441 | K871488 | VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH | LFJ | 1987-06-12 |
| 36072 | 1492089444 | K870915 | SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM | HRX | 1987-04-01 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| EZL | 23 | 2018-09-19 |
| FTL | 20 | 2009-08-03 |
| KNT | 18 | 2014-05-09 |
| KOD | 16 | 2026-02-23 |
| MJC | 14 | 2004-09-29 |
| MSD | 12 | 2009-05-28 |
| LJT | 11 | 2015-11-20 |
| DQY | 10 | 2016-08-04 |
| KNW | 8 | 2019-11-07 |
| KXK | 8 | 2014-05-02 |
| GCJ | 8 | 2004-07-01 |
| GBX | 8 | 1995-05-15 |
| FEN | 8 | 1995-05-11 |
| HET | 8 | 1994-06-14 |
| EZC | 8 | 1992-01-27 |
| FOZ | 6 | 2016-06-02 |
| OTP | 6 | 2009-01-15 |
| LFJ | 6 | 1988-06-23 |
| EZD | 5 | 2017-09-20 |
| DQX | 5 | 2010-08-31 |
| GBM | 5 | 1976-08-23 |
| FED | 4 | 2016-03-31 |
| LJS | 4 | 2015-01-27 |
| NFK | 4 | 2006-12-05 |
| FAD | 4 | 2004-12-07 |
| FFL | 4 | 1996-05-28 |
| FQH | 4 | 1994-07-19 |
| CAC | 4 | 1993-02-25 |
| LDF | 3 | 2025-05-15 |
| DWJ | 3 | 2016-09-02 |
| DTK | 3 | 2013-05-15 |
| LIT | 3 | 2012-04-19 |
| PNO | 3 | 2010-12-13 |
| FGE | 3 | 2005-08-24 |
| DSY | 3 | 2005-01-31 |
| EYB | 3 | 2003-11-14 |
| ITX | 3 | 2003-05-20 |
| GEI | 3 | 2002-01-29 |
| EXY | 3 | 1995-02-09 |
| FGH | 3 | 1991-03-27 |
C.R. Bard, Inc.
C.R. Bard, Inc.
C.R. Bard, Inc.
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