Data / Medical devices / Spain / B. Braun Surgical, S.A.
B. Braun Surgical, S.A.: FDA-registered device maker in RUBI Barcelona, Spain, 17 510(k) clearances
B. Braun Surgical, S.A. is registered with the FDA (registration 3003639970) in RUBI Barcelona, Spain. It lists 10 device types. The FDA files 17 510(k) clearances under its listings, the newest dated March 7, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003639970
- Address
- Carretera De Terrassa 121, RUBI Barcelona, Spain, 08191
- Owner or operator
- B. Braun Surgical, S.A. (10030447)
- Roles
- Complaint file establishment, Exporter to the US
- First device listed
- October 6, 2009
- Registered through
- 2026
- Brand names listed
- MANIPLER AZ
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Staple, Removable (Skin) | GDT | 1 | Complaint file establishment | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Complaint file establishment | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Complaint file establishment | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Complaint file establishment | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 2 | Complaint file establishment | accessdata.fda.gov |
| Suture, Recombinant Technology | NWJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 2 | Complaint file establishment | accessdata.fda.gov |
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 7, 2018 | K180321 | Aesculap Optilene Nonabsorbable Suture | GAW | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| October 23, 2017 | K171001 | Monosyn Quick Synthetic Absorbable Surgical Suture | GAM | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| June 8, 2017 | K170661 | Novosyn Quick Absorbable Suture | GAM | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| February 17, 2016 | K151165 | Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture | GAR | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| October 27, 2015 | K151865 | PremiPatch PTFE Pledget | DXZ | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 15, 2014 | K133890 | AESCULAP OPTILENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| May 13, 2014 | K140343 | AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP | MPN | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| May 17, 2013 | K121976 | AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE | MPN | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| December 18, 2012 | K122734 | AESCULAP NOVOSYN ABSORBABLE SUTURE | GAM | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| February 6, 2012 | K111959 | AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE | MPN | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 14, 2010 | K100876 | AESCULAP MONOMAX ABSORBABLE SUTURE | NWJ | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| July 17, 2003 | K031216 | MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE | NEW | Substantially Equivalent | Aesculap | accessdata.fda.gov |
| September 19, 2001 | K012201 | PREMICRON NONABSORBABLE PET SURGICAL SUTURE | GAT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| June 29, 2001 | K011375 | AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE | GAM | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 22, 1999 | K990090 | DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE | GAR | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| March 15, 1999 | K990089 | SILKAM NONABSORBABLE SILK SURGICAL SUTURE | GAP | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| February 10, 1999 | K990088 | SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE | GAT | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Synthetic, Polypropylene
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- All makers of Suture, Surgical, Absorbable, Polydioxanone
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
- All makers of Tissue Adhesive For The Topical Approximation Of Skin
Updated March 7, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.