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Panels › General Hospital › Product code FMG · Class 2

Stopcock, I.V. Set

Regulation 880.5440

0510(k)s in 12 months (89 all time)
19recalls in 12 months (207 all time)
204recalls that name a 510(k)
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Top companies in FMG

DateFirm and productCodeLinked 510(k)
Sep 11, 2026ICU Medical, Inc.
IV Sets with drip chambers
Open, Classified
FMGK964435
Sep 11, 2026ICU Medical, Inc.
IV Non-Dedicated Gravity Administration Sets with drip chambers
Open, Classified
FMGK964435
Jun 18, 2026BD SWITZERLAND SARL
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extensi
Open, Classified
FMGK974083
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK022895
Nov 26, 2025B Braun Medical Inc
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the followin
Open, Classified
FMGK060231
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK060231
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK060231
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK060231
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK060231
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK060231
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK060231
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK060231
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK022895
K032393
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK022895
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK022895
Nov 26, 2025B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as th
Open, Classified
FMGK022895
K032393
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FMGK060231
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FMGK060231
K083723 +1
Nov 26, 2025B Braun Medical Inc
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the fo
Open, Classified
FMGK060231
Oct 23, 2025ICU Medical, Inc.
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150
Open, Classified
FMGK964435
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Open, Classified
FMGNone listed
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Pr
Open, Classified
FMGK180739
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
Open, Classified
FMGK180739
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
Open, Classified
FMGK180739
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
Open, Classified
FMGK952074
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
Open, Classified
FMGK112893
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632
Open, Classified
FMGK112893
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
Open, Classified
FMGK112893
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
Open, Classified
FMGK153158
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571
Open, Classified
FMGK153158
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
Open, Classified
FMGK203609
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537
Open, Classified
FMGK203609
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
Open, Classified
FMGK203609
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Open, Classified
FMGK112893
Oct 16, 2025Baxter Healthcare Corporation
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Open, Classified
FMGK112893
Oct 16, 2025Baxter Healthcare Corporation
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255
Open, Classified
FMGK130245
Apr 2, 2025BD SWITZERLAND SARL
BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta Plus 1 and Connecta Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure mo
Open, Classified
FMGK974083
Aug 1, 2022ICU Medical, Inc.
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
Open, Classified
FMGK964435
May 9, 2022Becton Dickinson & Company
Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
Open, Classified
FMGK974083
May 9, 2022Becton Dickinson & Company
Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
Open, Classified
FMGK974083
May 9, 2022Becton Dickinson & Company
BD Connecta" Plus3 White Blend OEM (sterile, bulk) Catalog No. 395214 (OUS)
Open, Classified
FMGK974083
May 9, 2022Becton Dickinson & Company
BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
Open, Classified
FMGK974083
May 9, 2022Becton Dickinson & Company
BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
Open, Classified
FMGK974083
May 9, 2022Becton Dickinson & Company
BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
Open, Classified
FMGK974083
May 9, 2022Becton Dickinson & Company
BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)
Open, Classified
FMGK974083
May 9, 2022Becton Dickinson & Company
BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
Open, Classified
FMGK974083
May 9, 2022Becton Dickinson & Company
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
Open, Classified
FMGK974083
May 9, 2022Becton Dickinson & Company
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
Open, Classified
FMGK974083
May 9, 2022Becton Dickinson & Company
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
Open, Classified
FMGK974083
Dec 2, 2020ICU Medical, Inc.
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the adminis
Terminated
FMGK964435

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