{
  "companyId": "51209",
  "slug": "convatec-inc-51209",
  "name": "Convatec Inc.",
  "clearances": {
    "total": 112,
    "last12Months": 1,
    "first": "1982-09-07",
    "latest": "2026-04-01"
  },
  "medianReviewDays": 88,
  "productCodeCount": 30,
  "recalls": {
    "total": 71,
    "openLast12Months": 5,
    "recent": [
      {
        "resNumber": "Z-2677-2026",
        "productCode": "FRO",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-06-08",
        "reason": "Surgical dressing  manufactured out of specification (greater thickness)."
      },
      {
        "resNumber": "Z-1582-2026",
        "productCode": "FON",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-02-16",
        "reason": "Drainable large pouch may leak due to manufacturing issue."
      },
      {
        "resNumber": "Z-1583-2026",
        "productCode": "FON",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-02-16",
        "reason": "Drainable large pouch may leak due to manufacturing issue."
      },
      {
        "resNumber": "Z-1584-2026",
        "productCode": "FON",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2026-02-16",
        "reason": "Drainable large pouch may leak due to manufacturing issue."
      },
      {
        "resNumber": "Z-0160-2026",
        "productCode": "NAD",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2025-08-29",
        "reason": "Wound dressing may have foreign matter on the product."
      }
    ]
  },
  "registration": {
    "sites": 2,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "FRO",
      "deviceName": "Dressing, Wound, Drug",
      "clearances": 23,
      "latest": "2018-07-20",
      "medianReviewDays": 89
    },
    {
      "code": "KMF",
      "deviceName": "Bandage, Liquid",
      "clearances": 13,
      "latest": "1998-04-15",
      "medianReviewDays": 86
    },
    {
      "code": "EXB",
      "deviceName": "Collector, Ostomy",
      "clearances": 9,
      "latest": "1986-04-16",
      "medianReviewDays": 59
    },
    {
      "code": "KGX",
      "deviceName": "Tape And Bandage, Adhesive",
      "clearances": 6,
      "latest": "1994-03-01",
      "medianReviewDays": 73
    },
    {
      "code": "EZD",
      "deviceName": "Catheter, Straight",
      "clearances": 5,
      "latest": "2026-04-01",
      "medianReviewDays": 168
    },
    {
      "code": "KNT",
      "deviceName": "Tubes, Gastrointestinal (And Accessories)",
      "clearances": 5,
      "latest": "2025-03-28",
      "medianReviewDays": 160
    },
    {
      "code": "KNX",
      "deviceName": "Collector, Urine, (And Accessories) For Indwelling Catheter",
      "clearances": 5,
      "latest": "1995-08-15",
      "medianReviewDays": 50
    },
    {
      "code": "EYQ",
      "deviceName": "Garment, Protective, For Incontinence",
      "clearances": 4,
      "latest": "1986-11-19",
      "medianReviewDays": 30
    },
    {
      "code": "LRJ",
      "deviceName": "Disinfectant, Medical Devices",
      "clearances": 4,
      "latest": "1998-01-13",
      "medianReviewDays": 21
    },
    {
      "code": "NAD",
      "deviceName": "Dressing, Wound, Occlusive",
      "clearances": 4,
      "latest": "1989-05-11",
      "medianReviewDays": 21
    },
    {
      "code": "EXJ",
      "deviceName": "Device, Incontinence, Urosheath Type, Sterile",
      "clearances": 3,
      "latest": "1996-10-25",
      "medianReviewDays": 39
    },
    {
      "code": "EZQ",
      "deviceName": "Pouch, Colostomy",
      "clearances": 3,
      "latest": "2011-08-19",
      "medianReviewDays": 95
    },
    {
      "code": "FAQ",
      "deviceName": "Bag, Urine Collection, Leg, For External Use, Sterile",
      "clearances": 3,
      "latest": "1996-07-18",
      "medianReviewDays": 29
    },
    {
      "code": "KOD",
      "deviceName": "Catheter, Urological",
      "clearances": 3,
      "latest": "2017-11-21",
      "medianReviewDays": 109
    },
    {
      "code": "EXI",
      "deviceName": "Device, Paste-On For Incontinence, Sterile",
      "clearances": 2,
      "latest": "1993-06-22",
      "medianReviewDays": 38
    },
    {
      "code": "GBM",
      "deviceName": "Catheter, Urethral",
      "clearances": 2,
      "latest": "2022-06-22",
      "medianReviewDays": 101
    },
    {
      "code": "KGN",
      "deviceName": "Wound Dressing With Animal-Derived Material(S)",
      "clearances": 2,
      "latest": "1999-05-18",
      "medianReviewDays": 56
    },
    {
      "code": "KNY",
      "deviceName": "Accessories, Catheter, G-U",
      "clearances": 2,
      "latest": "1993-12-01",
      "medianReviewDays": 15
    },
    {
      "code": "MCY",
      "deviceName": "Wound Dressing Kit",
      "clearances": 2,
      "latest": "1995-06-12",
      "medianReviewDays": 97
    },
    {
      "code": "MGQ",
      "deviceName": "Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic",
      "clearances": 2,
      "latest": "1993-12-27",
      "medianReviewDays": 78
    },
    {
      "code": "EXD",
      "deviceName": "Irrigator, Ostomy",
      "clearances": 1,
      "latest": "1983-08-26",
      "medianReviewDays": 44
    },
    {
      "code": "EXE",
      "deviceName": "Protector, Ostomy",
      "clearances": 1,
      "latest": "1991-03-06",
      "medianReviewDays": 182
    },
    {
      "code": "FCM",
      "deviceName": "Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)",
      "clearances": 1,
      "latest": "2025-06-06",
      "medianReviewDays": 73
    },
    {
      "code": "JOW",
      "deviceName": "Sleeve, Limb, Compressible",
      "clearances": 1,
      "latest": "2008-03-07",
      "medianReviewDays": 252
    },
    {
      "code": "KMK",
      "deviceName": "Device, Intravascular Catheter Securement",
      "clearances": 1,
      "latest": "1993-10-15",
      "medianReviewDays": 324
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "30",
  "recentClearances": [
    {
      "kNumber": "K252943",
      "deviceName": "GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women",
      "productCode": "EZD",
      "decisionDate": "2026-04-01",
      "reviewDays": 198
    },
    {
      "kNumber": "K250699",
      "deviceName": "Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)",
      "productCode": "EZD",
      "decisionDate": "2025-07-01",
      "reviewDays": 116
    },
    {
      "kNumber": "K250891",
      "deviceName": "Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C",
      "productCode": "FCM",
      "decisionDate": "2025-06-06",
      "reviewDays": 73
    },
    {
      "kNumber": "K243228",
      "deviceName": "Flexi-Seal AIR (with ENFit Connector)",
      "productCode": "KNT",
      "decisionDate": "2025-03-28",
      "reviewDays": 171
    },
    {
      "kNumber": "K232665",
      "deviceName": "GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)",
      "productCode": "EZD",
      "decisionDate": "2024-01-25",
      "reviewDays": 147
    },
    {
      "kNumber": "K230400",
      "deviceName": "Cure Catheter Closed System; Cure Dextra Closed System",
      "productCode": "EZD",
      "decisionDate": "2023-11-08",
      "reviewDays": 266
    },
    {
      "kNumber": "K221593",
      "deviceName": "Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus",
      "productCode": "EZD",
      "decisionDate": "2022-11-17",
      "reviewDays": 168
    },
    {
      "kNumber": "K213283",
      "deviceName": "GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter",
      "productCode": "GBM",
      "decisionDate": "2022-06-22",
      "reviewDays": 264
    },
    {
      "kNumber": "K190114",
      "deviceName": "Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)",
      "productCode": "KNT",
      "decisionDate": "2019-04-30",
      "reviewDays": 96
    },
    {
      "kNumber": "K180205",
      "deviceName": "AVELLE Negative Pressure Wound Therapy System",
      "productCode": "OMP",
      "decisionDate": "2018-10-19",
      "reviewDays": 268
    }
  ],
  "nameVariants": {
    "total": "13",
    "shown": [
      {
        "name": "CONVATEC LIMITED",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "ConvaTec",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "ConvaTec, Inc",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "ConvaTec, Inc",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "ConvaTec, Inc.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Convatec",
        "dataset": "device/510k",
        "method": "normalised"
      },
      {
        "name": "Convatec Inc.",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Convatec Inc.",
        "dataset": "device/enforcement",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Convatec%20Inc.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Convatec%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": "2026-08-11T14:48:53.039Z"
}