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Organization (Industry)

B Braun Medical SpA

ClinicalTrials.gov lists B Braun Medical SpA as lead sponsor of 19 trials. It has 5 approved assets.

CL Industry Manufacturer
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4 0 1999 2026

Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.

2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.0 trial starts a year over the five years to September, under the 5 a year the method needs.

This page covers B Braun Medical SpA: 19 lead-sponsored trials and 4 legal-entity registrations. The parent company on record for B Braun Medical SpA is B. Braun Holding GmbH & Co. KG, which does not have its own page on this site.

Related companies are recorded in the same corporate group by GLEIF, ROR or a curator but are not grouped here; they are listed below with their own counts and are not included in the figures above.

Get the B Braun Medical SpA report as a PDF

The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

Disease areas (27)

Shown in this order: most trials first (counted at this company's own legal-entity record, not the consolidated group).

Trials by start year as sponsor or collaborator (16)

Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Show the table of trials by start year as sponsor or collaborator
Trials by start year as sponsor or collaborator
Year Trials started
2023 3
2022 2
2020 3
2019 2
2018 1
2017 2
2016 1
2013 3
2012 4
2011 2

Recruitment duration, a model prediction: none of the 19 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Approved assets (5)

Shown in this order: max phase first.

Approved assets
Drug Trials
MCT/LCT 1
Cefazolin 2 g Infusion 1
Mupirocin + Chlorhexidin 1
MCT/LCT/omega-3 (5:4:1) 1
Cefazolin 1 g Infusion 1

Sponsor delivery record (1)

Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.

Sponsor delivery record
Enrollment Timeline
20% hit target (n=5) 20% on time (n=5)

FDA inspection record (1)

FDA inspection record
Latest classification Inspections
VAI 3

FDA recalls (444)

Shown in this order: most recent first.

FDA recalls
Product Classification Initiated
Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK PENCAN SPINAL W/BUPIVAC (333871); P25BK SPINAL TRAY (333851) Class I 2026-05-06
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333201); Spinocan 25 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333211); Spinocan 22 Ga. x 3-1/2 in. (90 mm), Bupivacaine 0.75% with Dextrose 8.25% Tray (Kit) (333231) Class I 2026-05-06
Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material Number): SSK H M C 20061890 (560074), SSK S C H (560214), SSK BJC H S (ORIGINAL CUST) (560272), SSK CA P M C (ORIGINAL CUST) (560327), SSK T M H (560394), SSK S O 20070208 (560428), SSK L G H (ORIGINAL CUST) (560462), SSK H M H (560465), SSK BUPIVACAINE TRAY 2068824 (560476), SSK K F H (560497), SSK T J U H (560513), SSK O M C (560521), SSK CUSTOM SPINAL TRAY (560523), SSK O R M C (560533), SSK B S H S 20115122 (560538), SSK M M (560572), SSK M S 27GA PENCAN SPINAL TRAY (560580), SSK S T H & C (560584), SSK U C (560587), SSK P25BKG (560603), SSK P24BKG (560606), SSK S25BKG (560607), SSK M C - BUPIVACAINE TRAY (560609), SSK T M C (560613), SSK PENCIL POINT SPINAL TRAY (560619), SSK E O & S H-SPINAL (560621), SSK BSW SPINAL TRAY (560628), SSK M C OB DEPT - SPINAL (560645), SSK B H M (560646), SSK M G M C (560647), SSK S M H (560648), SSK H H S (560660), O S U M C SPINAL TRAY SSK (560667), A M C, SSK (560670), S B H - SPINAL TRAY SSK (560672); Class I 2026-05-06
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07. Class I 2026-04-28
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60. Class II 2026-04-02

FDA import refusals (1)

FDA import refusals
Refused import lines Latest refusal
12 2025-03-10

Manufacturing and distribution sites (11)

Shown in this order: severity rank then name.

Manufacturing and distribution sites
Facility Location Regulators Member organization
B. BRAUN MEDICAL INC. BETHLEHEM, US FDA
B. BRAUN MEDICAL INC. Allentown, US FDA
B.Braun Medical Ludres, FR EMA B. Braun Medical
B BRAUN MEDICAL S.A. Jaen, ES EMA B Braun Medical S.A.
B BRAUN MEDICAL S.A. Alcobendas, ES EMA B Braun Medical S.A.

Biomarker capability evidence (15)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
ABO Trial collaborator Named in trial inclusion criteria
ALB Trial sponsor Named in trial exclusion criteria
ALB Trial sponsor Named in trial exclusion criteria
BCHE Trial collaborator Named in trial exclusion criteria
BTBD8 Trial sponsor Named in trial exclusion criteria

Not on this page

Checked, with nothing recorded for this organization: companies grouped under this page, active development programs, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, organization relationships, and clia clinical laboratory certificates.

Counted at group level under Aesculap (United States): journals published in, us granted patents, latest dated events, and biomarkers this organization publishes on.