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FOZ

506 FDA 510(k) clearances · Product code

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RecordFirmDate
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (K003553)Bd Becton Dickinson Vacutainer Systems Preanalytic2001-03-21
MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S (K010021)Medical Components, Inc.2001-02-23
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- (K010034)Cook, Inc.2001-01-24
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML (K003245)Baxter Healthcare Corp2000-12-04
BIOSENSORS CENTRAL VENOUS CATHETER KITS (K002786)Sunscope Intl., Inc.2000-11-17
THE AVITRO LLC, 10 AND 100 USO UNITS/ML HEPARIN SODIUM VAFD (K001795)Avitro, LLC2000-10-19
0.9% SODIUM CHLORIDE VASCULAT ACCESS DEVICE (K000632)Avitro, LLC2000-10-19
ZORTRAN DETECTOR (K000997)Lucent Medical Systems2000-09-07
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE (K001616)Abbott Laboratories2000-07-27
BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS (K002033)Becton Dickinson Infusion Therapy Systems, Inc.2000-07-26
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING (K992532)Baxter Healthcare Corp2000-06-13
MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL (K993518)Medefil, Inc.2000-06-12
TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER (K000665)Tfx Medical, Inc.2000-05-02
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE (K992732)Dumex Medical Surgical Products, Ltd.2000-04-20
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER (K000235)Becton Dickinson Infusion Therapy Systems, Inc.2000-04-05
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR (K000087)The Kendal Co.2000-03-17
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER (K993691)Arrow Intl., Inc.2000-03-08
BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE (K982558)Bd/Preefil2000-03-08
MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L (K993515)Medefil, Inc.2000-02-25
HEPARIN IV FLUSH SYRINGE, 10 U/ML \ (K990390)Rocap Div. of Sabratek Corp.1999-12-10
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML (K990308)Rocap Div. of Sabratek Corp.1999-12-10
0.9% SODIUM CHLORIDE FLUSH SYRINGE (K984590)Baxter Healthcare Corp1999-10-07
URETHANE PICC LINE MODEL UPICS- (K992198)Cook, Inc.1999-08-27
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT (K990236)Johnson & Johnson Medical, Div. of Ethicon, Inc.1999-08-20
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER (K991406)Terumo Medical Corp.1999-06-16
NORMAL SALINE FLUSH SYRINGE (K984614)Rocap Div. of Sabratek Corp.1999-05-27
ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER (K984189)Maxxim Medical1999-05-05
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER (K984059)Bd Becton Dickinson Vacutainer Systems Preanalytic1999-04-09
CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS (K984055)Sims Deltec, Inc.1999-01-29
INTROCAN SAFETY IV CATHETER (K982805)B.Braun Medical, Inc.1999-01-14
BRAUN PREFILLED SYRINGE (K970736)B.Braun Medical, Inc.1998-12-16
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) (K983916)Hdc Corp.1998-11-23
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) SEE APPENDIX 1 (K983409)Hdc Corp.1998-10-16
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER (K980566)Boston Scientific Corp1998-09-14
STERILE SALINE SOLUTION 0.9%- CATALOG NO, 10290, STERILE WATER- CATALOG NO. 10291 (K981905)Acu-Pak1998-08-18
ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL (K974015)Davis & Geck, Inc.1998-05-18
MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M (K973561)Medical Components, Inc.1998-05-11
PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS (K981382)Catheter Innovations, Inc.1998-05-01
PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER PIC-NUMEROUS (K981368)Catheter Innovations, Inc.1998-05-01
I.V. CATHETER SYSTEM (K980493)Johnson & Johnson Medical, Inc.1998-04-28
INTROSYTE CATHETER (K974764)Becton Dickinson Infusion Therapy Systems, Inc.1998-02-26
L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGER (K974543)Luther Medical Products, Inc.1998-02-10
INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS (K971339)Becton Dickinson Vascular Access, Inc.1997-12-24
GESCO PER-Q-CATH PICC CATHETERS (K971990)Bard Access Systems, Inc.1997-11-07
GESCO PER-Q-CATH MIDLINE CATHETERS (K971991)Bard Access Systems, Inc.1997-11-07
ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS (K970864)Arrow Intl., Inc.1997-10-17
FIRST PICC CATHETER WITH DUAL LUMENS (K972263)Becton Dickinson Infusion Therapy Systems, Inc.1997-09-15
FIRST MIDCATH CATHETER (K972264)Becton Dickinson Infusion Therapy Systems, Inc.1997-09-15
FIRST PICC CATHETER (K972262)Becton Dickinson Infusion Therapy Systems, Inc.1997-09-15
FIRST MIDCATH CATHETER (K972254)Becton Dickinson Infusion Therapy Systems, Inc.1997-09-12
VYGON UMBILICAL CATHETHER INSERTION TRAY (K963196)Vygon Corp.1997-09-09
ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER (K962577)Arrow Intl., Inc.1997-08-21
AEROQUIP SAFESTART IV CATHETER (K970669)Aeroquip Medical Products1997-08-01
AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM (K970644)Aeroquip Medical Products1997-07-31
SAFE-CATH (K960764)Scientific Device Manufacturer, LLC1997-04-24
V-CATH (K964966)Hdc Corp.1997-03-05
CVP POLYURETHANE CATHETER (K961552)Abbott Laboratories1997-02-10
FIRST MIDCATH CATHETER (K964050)Becton Dickinson Vascular Access, Inc.1997-01-06
FIRST MIDCATH CATHETER KIT (K964048)Becton Dickinson Vascular Access, Inc.1997-01-06
FIRST MIDCATH CATHETER WITH DUAL LUMENS (K964049)Becton Dickinson Vascular Access, Inc.1997-01-06
PROTECTIV 2000 I.V. CATHETER SAFETY SYSTEM (K962226)Johnson & Johnson Medical, Inc.1996-12-23
DISPOSABLE SCALP VEIN INFUSION SET (K953252)Myco Medical Supplies, Inc.1996-11-26
NEO-CARE CATHETERIZATION TRAY (K963867)Klein-Baker Medical, Inc.1996-11-06
EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) (K962938)Excelsior Medical Corp.1996-10-25
MEDCOMP P-CATH (K953811)Medcomp1996-07-25
0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE (K953805)Abbott Laboratories1996-06-28
VYGON LIFEVAC MID-LINE TRAY (K954112)Vygon Corp.1996-05-09
MIDMARK MIDLINE CATHETER (K951620)Menlo Care, Inc.1996-04-04
SOLOPICC 24 (60CM) 20GA CATHETER (K954428)Douglas Medical Products Corp.1996-03-28
NIPRO SAFELET CATH (K960051)Nissho Corp.1996-03-28
MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER (K955839)Baxter Edwards1996-03-25
MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM (K960013)MDC Research , Ltd.1996-02-13
ABRM CATHETER (K950118)Cook, Inc.1996-02-08
STERILE WATER O.9% STERILE SALINE (K954887)Lockett Medical Corp.1996-01-24
MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER (K953335)Micro Therapeutics, Inc.1996-01-23
NIPRO SCALP VEIN SET (DISPOSABL PSV SET) (K955053)Nissho Corp.1996-01-04
VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE (K952645)Vital Signs, Inc.1995-12-13
VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE (K953120)Vital Signs, Inc.1995-12-13
COMFORT-Q SUBCUTANEOUS INJECTION SETS (K946170)B. Braun of America, Inc.1995-11-03
STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE (K952058)Trinity Laboratories, Inc.1995-09-21
WALLACE IV CANNULA (K932946)Smiths Industries Medical Systems, Inc.1995-09-01
WALLACE Y-CAN (K932947)Smiths Industries Medical Systems, Inc.1995-09-01
ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER (K952757)Becton Dickinson Vascular Access, Inc.1995-07-31
PICC LINE KIT (K952256)Medi-Flex Hospital Products, Inc.1995-07-31
ANGIOCATH & INSYTE AUTOGUARD CATHETERS (K952861)Becton Dickinson Vascular Access, Inc.1995-07-31
BIONECTOR (K941678)Vygon Corp.1995-06-26
SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR (K950284)Sims Deltec, Inc.1995-05-23
LF CT HIG PRESSURE CATHETERS (K945053)Mallinckrodt Group, Inc.1995-05-19
ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS (K950301)Becton Dickinson Vascular Access, Inc.1995-04-18
THE FLEX-SET SUBCUTANEOUS INFUSION SET (K944302)Cathco, Inc.1995-04-10
CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY (K945521)Menlo Care, Inc.1995-04-06
CATCO SILICONE UMBILICAL VESSEL CATHETER (K944368)Catco Medical, Inc.1995-04-05
CATCO POLYURETHANE UMBILICAL VESSEL CATHETER (K944367)Catco Medical, Inc.1995-04-05
CATCO UMBILICAL VESSEL CATHETER (K944336)Catco Medical, Inc.1995-04-05
CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER (K944410)Catco Medical, Inc.1995-04-05
CATCO FIRST PICC (K944504)Catco Medical, Inc.1995-03-31
LANDMARK MIDLINE CATHETER (K944968)Menlo Care, Inc.1995-03-29
LANDMARK MIDLINE CATHETER (K950737)Menlo Care, Inc.1995-03-29
MAHURKAR DUAL LUMEN CATHETER (K943349)Quinton, Inc.1995-03-22
ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC) (K944511)Neostar Medical Technologies, Inc.1995-03-13
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