{
  "companyId": "52483",
  "slug": "b-braun-medical-inc-52483",
  "name": "B. Braun Medical, Inc.",
  "clearances": {
    "total": 151,
    "last12Months": 1,
    "first": "1993-08-06",
    "latest": "2026-05-15"
  },
  "medianReviewDays": 141,
  "productCodeCount": 44,
  "recalls": {
    "total": 508,
    "openLast12Months": 150,
    "recent": [
      {
        "resNumber": "Z-2276-2026",
        "productCode": "OFU",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-05-06",
        "reason": "A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues."
      },
      {
        "resNumber": "Z-2277-2026",
        "productCode": "OFU",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-05-06",
        "reason": "A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues."
      },
      {
        "resNumber": "Z-2278-2026",
        "productCode": "OFU",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-05-06",
        "reason": "A sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huon Co, Ltd. has issued a voluntary recall due to potential quality issues."
      },
      {
        "resNumber": "Z-1798-2026",
        "productCode": "FJK",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-03-19",
        "reason": "Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure."
      },
      {
        "resNumber": "Z-1799-2026",
        "productCode": "FJK",
        "status": "Open, Classified",
        "recallClass": "Class I",
        "initiated": "2026-03-19",
        "reason": "Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure."
      }
    ]
  },
  "registration": {
    "sites": 6,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "FPA",
      "deviceName": "Set, Administration, Intravascular",
      "clearances": 22,
      "latest": "2025-07-24",
      "medianReviewDays": 145
    },
    {
      "code": "FOZ",
      "deviceName": "Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days",
      "clearances": 12,
      "latest": "2026-05-15",
      "medianReviewDays": 146
    },
    {
      "code": "FRN",
      "deviceName": "Pump, Infusion",
      "clearances": 11,
      "latest": "2018-06-12",
      "medianReviewDays": 86
    },
    {
      "code": "DYB",
      "deviceName": "Introducer, Catheter",
      "clearances": 9,
      "latest": "2004-02-05",
      "medianReviewDays": 130
    },
    {
      "code": "LHI",
      "deviceName": "Set, I.V. Fluid Transfer",
      "clearances": 9,
      "latest": "2020-12-09",
      "medianReviewDays": 139
    },
    {
      "code": "CAZ",
      "deviceName": "Anesthesia Conduction Kit",
      "clearances": 7,
      "latest": "2012-01-24",
      "medianReviewDays": 129
    },
    {
      "code": "FRO",
      "deviceName": "Dressing, Wound, Drug",
      "clearances": 7,
      "latest": "2017-05-23",
      "medianReviewDays": 150
    },
    {
      "code": "BSO",
      "deviceName": "Catheter, Conduction, Anesthetic",
      "clearances": 6,
      "latest": "2023-09-15",
      "medianReviewDays": 90
    },
    {
      "code": "FMF",
      "deviceName": "Syringe, Piston",
      "clearances": 6,
      "latest": "2020-03-05",
      "medianReviewDays": 83
    },
    {
      "code": "BSP",
      "deviceName": "Needle, Conduction, Anesthetic (W/Wo Introducer)",
      "clearances": 5,
      "latest": "2014-06-27",
      "medianReviewDays": 114
    },
    {
      "code": "FMI",
      "deviceName": "Needle, Hypodermic, Single Lumen",
      "clearances": 5,
      "latest": "2018-06-11",
      "medianReviewDays": 89
    },
    {
      "code": "LJS",
      "deviceName": "Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days",
      "clearances": 4,
      "latest": "1997-11-24",
      "medianReviewDays": 141
    },
    {
      "code": "LJT",
      "deviceName": "Port & Catheter, Implanted, Subcutaneous, Intravascular",
      "clearances": 4,
      "latest": "1996-12-16",
      "medianReviewDays": 78
    },
    {
      "code": "DQX",
      "deviceName": "Wire, Guide, Catheter",
      "clearances": 3,
      "latest": "1997-12-19",
      "medianReviewDays": 195
    },
    {
      "code": "DXT",
      "deviceName": "Injector And Syringe, Angiographic",
      "clearances": 3,
      "latest": "1997-03-19",
      "medianReviewDays": 212
    },
    {
      "code": "GBM",
      "deviceName": "Catheter, Urethral",
      "clearances": 3,
      "latest": "2020-05-07",
      "medianReviewDays": 224
    },
    {
      "code": "KPO",
      "deviceName": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",
      "clearances": 3,
      "latest": "2005-11-09",
      "medianReviewDays": 67
    },
    {
      "code": "DQO",
      "deviceName": "Catheter, Intravascular, Diagnostic",
      "clearances": 2,
      "latest": "1996-02-23",
      "medianReviewDays": 84
    },
    {
      "code": "DTK",
      "deviceName": "Filter, Intravascular, Cardiovascular",
      "clearances": 2,
      "latest": "2024-07-31",
      "medianReviewDays": 80
    },
    {
      "code": "KDI",
      "deviceName": "Dialyzer, High Permeability With Or Without Sealed Dialysate System",
      "clearances": 2,
      "latest": "1998-11-10",
      "medianReviewDays": 432
    },
    {
      "code": "KPE",
      "deviceName": "Container, I.V.",
      "clearances": 2,
      "latest": "2008-03-12",
      "medianReviewDays": 69
    },
    {
      "code": "LIT",
      "deviceName": "Catheter, Angioplasty, Peripheral, Transluminal",
      "clearances": 2,
      "latest": "1995-06-22",
      "medianReviewDays": 94
    },
    {
      "code": "BSS",
      "deviceName": "Tube, Nasogastric",
      "clearances": 1,
      "latest": "1997-06-11",
      "medianReviewDays": 405
    },
    {
      "code": "BXN",
      "deviceName": "Stimulator, Nerve, Battery-Powered",
      "clearances": 1,
      "latest": "2003-03-21",
      "medianReviewDays": 357
    },
    {
      "code": "DQY",
      "deviceName": "Catheter, Percutaneous",
      "clearances": 1,
      "latest": "1997-11-24",
      "medianReviewDays": 77
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "44",
  "recentClearances": [
    {
      "kNumber": "K253235",
      "deviceName": "Introcan Safety® Deep Access XL IV Catheter",
      "productCode": "FOZ",
      "decisionDate": "2026-05-15",
      "reviewDays": 228
    },
    {
      "kNumber": "K243392",
      "deviceName": "Infusomat® Space Volumetric Infusion Pump Administration Sets",
      "productCode": "FPA",
      "decisionDate": "2025-07-24",
      "reviewDays": 266
    },
    {
      "kNumber": "K240578",
      "deviceName": "VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System",
      "productCode": "DTK",
      "decisionDate": "2024-07-31",
      "reviewDays": 152
    },
    {
      "kNumber": "K241845",
      "deviceName": "Introcan Safety® 2 IV Catheter",
      "productCode": "FOZ",
      "decisionDate": "2024-07-26",
      "reviewDays": 30
    },
    {
      "kNumber": "K241385",
      "deviceName": "Omnifix Syringe NRFit",
      "productCode": "QEH",
      "decisionDate": "2024-07-13",
      "reviewDays": 59
    },
    {
      "kNumber": "K231242",
      "deviceName": "Perifix FX Catheter; Contiplex FX Catheter",
      "productCode": "BSO",
      "decisionDate": "2023-09-15",
      "reviewDays": 137
    },
    {
      "kNumber": "K223479",
      "deviceName": "AQUAbase nX",
      "productCode": "FIP",
      "decisionDate": "2023-08-16",
      "reviewDays": 271
    },
    {
      "kNumber": "K220756",
      "deviceName": "Introcan Safety 2 IV Catheter",
      "productCode": "FOZ",
      "decisionDate": "2022-06-23",
      "reviewDays": 100
    },
    {
      "kNumber": "K220626",
      "deviceName": "Introcan Safety IV Catheter",
      "productCode": "FOZ",
      "decisionDate": "2022-05-14",
      "reviewDays": 71
    },
    {
      "kNumber": "K213778",
      "deviceName": "IV Administration Set",
      "productCode": "FPA",
      "decisionDate": "2022-03-03",
      "reviewDays": 90
    }
  ],
  "nameVariants": {
    "total": "17",
    "shown": [
      {
        "name": "B BRAUN MEDICAL INC",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "B BRAUN MEDICAL INC",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "B Braun Medical Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "B Braun Medical Inc",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "B Braun Medical, Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "B Braun Medical, Inc.",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "B Braun Medical, Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "B. BRAUN MEDICAL",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22B.%20Braun%20Medical%2C%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22B.%20Braun%20Medical%2C%20Inc.%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.033Z"
}