{
  "companyId": "56953",
  "slug": "richard-wolf-medical-instruments-corp-56953",
  "name": "Richard Wolf Medical Instruments Corp.",
  "clearances": {
    "total": 153,
    "last12Months": 0,
    "first": "1977-03-07",
    "latest": "2024-06-03"
  },
  "medianReviewDays": 90,
  "productCodeCount": 51,
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    "total": 12,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1957-2019",
        "productCode": "HIH",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2019-05-23",
        "reason": "E-Line Cutting Electrode package 8416.0305 contains E-Line Hook Electrode 8416.09 instead of E-Line Cutting Electrode 8416.03."
      },
      {
        "resNumber": "Z-2608-2016",
        "productCode": "HHI",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2016-05-19",
        "reason": "The distal end of the Conical portio adapter (acorn) is composed of a small cap (head) that partially sits inside a hollow shaft (tube). These two parts are welded together to create one piece. In the  impacted batches of product, the weld was improperly performed. As a result, the two pieces are not properly joined. This potential failure can result in the separation of the two pieces. The possible separation of these two components presents a potential risk to patients."
      },
      {
        "resNumber": "Z-1188-2016",
        "productCode": "FWE",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2016-02-29",
        "reason": "Supplier of the \"VESA 75 / 100 adaptation with rotation\", which is part of their monitor mounts and support arms may be missing riveting."
      },
      {
        "resNumber": "Z-0789-2016",
        "productCode": "HRX",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2015-11-25",
        "reason": "Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional."
      },
      {
        "resNumber": "Z-0790-2016",
        "productCode": "HRX",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2015-11-25",
        "reason": "Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional."
      }
    ]
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    "sites": 1,
    "countries": [
      "US"
    ]
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      "code": "GCJ",
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      "latest": "2008-05-14",
      "medianReviewDays": 84
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      "code": "HRX",
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      "medianReviewDays": 147
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    {
      "code": "GEI",
      "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories",
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      "latest": "2023-03-22",
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    },
    {
      "code": "HET",
      "deviceName": "Laparoscope, Gynecologic (And Accessories)",
      "clearances": 9,
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      "medianReviewDays": 68
    },
    {
      "code": "FET",
      "deviceName": "Endoscopic Video Imaging System/Component, Gastroenterology-Urology",
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      "latest": "2022-06-14",
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    },
    {
      "code": "HIF",
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      "medianReviewDays": 391
    },
    {
      "code": "HIH",
      "deviceName": "Hysteroscope (And Accessories)",
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      "medianReviewDays": 174
    },
    {
      "code": "FGB",
      "deviceName": "Ureteroscope And Accessories, Flexible/Rigid",
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      "latest": "2021-01-15",
      "medianReviewDays": 165
    },
    {
      "code": "FFK",
      "deviceName": "Lithotriptor, Electro-Hydraulic",
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    {
      "code": "GCT",
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    {
      "code": "FJL",
      "deviceName": "Resectoscope",
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      "medianReviewDays": 182
    },
    {
      "code": "GWG",
      "deviceName": "Endoscope, Neurological",
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      "latest": "2004-07-29",
      "medianReviewDays": 286
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    {
      "code": "HWE",
      "deviceName": "Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment",
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      "latest": "1997-04-07",
      "medianReviewDays": 61
    },
    {
      "code": "EOB",
      "deviceName": "Nasopharyngoscope (Flexible Or Rigid)",
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      "latest": "1999-09-24",
      "medianReviewDays": 58
    },
    {
      "code": "FAJ",
      "deviceName": "Cystoscope And Accessories, Flexible/Rigid",
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      "latest": "2005-10-05",
      "medianReviewDays": 108
    },
    {
      "code": "FBN",
      "deviceName": "Choledochoscope And Accessories, Flexible/Rigid",
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      "latest": "1996-12-02",
      "medianReviewDays": 8
    },
    {
      "code": "FBO",
      "deviceName": "Cystourethroscope",
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      "latest": "2001-08-10",
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    },
    {
      "code": "FGA",
      "deviceName": "Kit, Nephroscope",
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      "medianReviewDays": 8
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    {
      "code": "GCM",
      "deviceName": "Endoscope, Rigid",
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      "latest": "2021-05-14",
      "medianReviewDays": 85
    },
    {
      "code": "HIN",
      "deviceName": "Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)",
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      "latest": "1999-04-16",
      "medianReviewDays": 87
    },
    {
      "code": "ODA",
      "deviceName": "Endoscopic Central Control Unit",
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      "latest": "2016-01-12",
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    },
    {
      "code": "ECB",
      "deviceName": "Unit, Syringe, Air And/Or Water",
      "clearances": 1,
      "latest": "1991-10-24",
      "medianReviewDays": 189
    },
    {
      "code": "EQL",
      "deviceName": "Laryngostroboscope",
      "clearances": 1,
      "latest": "1999-03-17",
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    },
    {
      "code": "EWY",
      "deviceName": "Mediastinoscope, Surgical",
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      "latest": "1997-08-27",
      "medianReviewDays": 149
    },
    {
      "code": "EZN",
      "deviceName": "Dilator, Catheter, Ureteral",
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  "productCodesTotal": "51",
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      "deviceName": "Perforated Baskets",
      "productCode": "KCT",
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    {
      "kNumber": "K230194",
      "deviceName": "HF Surgery Generator 400KHZ",
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    {
      "kNumber": "K212808",
      "deviceName": "Logic Hd camera head green, System green",
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    {
      "kNumber": "K211332",
      "deviceName": "D Camera Controller",
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    },
    {
      "kNumber": "K203226",
      "deviceName": "TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM",
      "productCode": "GCM",
      "decisionDate": "2021-05-14",
      "reviewDays": 193
    },
    {
      "kNumber": "K201897",
      "deviceName": "Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525",
      "productCode": "FGB",
      "decisionDate": "2021-01-15",
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    {
      "kNumber": "K200617",
      "deviceName": "Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525",
      "productCode": "FET",
      "decisionDate": "2020-06-23",
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    {
      "kNumber": "K183188",
      "deviceName": "Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF",
      "productCode": "FGB",
      "decisionDate": "2019-05-03",
      "reviewDays": 165
    },
    {
      "kNumber": "K180583",
      "deviceName": "LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD",
      "productCode": "FET",
      "decisionDate": "2018-06-28",
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    },
    {
      "kNumber": "K170377",
      "deviceName": "TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM",
      "productCode": "GEI",
      "decisionDate": "2017-04-05",
      "reviewDays": 57
    }
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        "name": "RICHARD WOLF MEDICAL INSTRUMENTS CORP.",
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        "method": "normalised"
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    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Richard%20Wolf%20Medical%20Instruments%20Corp.%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Richard%20Wolf%20Medical%20Instruments%20Corp.%22"
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  "retrievedAt": "2026-08-11T14:48:53.033Z"
}