ClearanceBrief
Company

BD SWITZERLAND SARL

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
15recalls (4 in 12 months)
12recalls that name a 510(k)

Product codes

CodeDeviceRecords
FPASet, Administration, Intravascular10
FMFSyringe, Piston2
FMGStopcock, I.V. Set2
ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 15, 2026BD SWITZERLAND SARL
BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Ala
Open, Classified
FPAK022209
Aug 13, 2026BD SWITZERLAND SARL
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-
Open, Classified
FPAK051499
K083472
Jul 2, 2026BD SWITZERLAND SARL
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
Open, Classified
FPANone listed
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
Aug 27, 2025BD SWITZERLAND SARL
BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 51500
Open, Classified
ONBK123213
K130197 +3
Jun 12, 2025BD SWITZERLAND SARL
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA
Open, Classified
FPANone listed
Jun 12, 2025BD SWITZERLAND SARL
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Open, Classified
FPAK053049
Jun 12, 2025BD SWITZERLAND SARL
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
Open, Classified
FMFNone listed
Jun 12, 2025BD SWITZERLAND SARL
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
Open, Classified
FMFK071108
Jun 12, 2025BD SWITZERLAND SARL
Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Ma
Open, Classified
FPAK053049
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
May 31, 2024BD SWITZERLAND SARL
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set used for delivery of fluids, medication, blood and blood products.
Open, Classified
FPAK022209
Apr 9, 2020BD SWITZERLAND SARL
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-s
Terminated
FPAK811885
Apr 9, 2020BD SWITZERLAND SARL
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve
Terminated
FPAK811885
Apr 9, 2020BD SWITZERLAND SARL
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve
Terminated
FPAK811885
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