Shippert Medical Technologies Corp.
United StatesFDA applicant, unverified
- Devices
- 595
- FDA recalls
- 15
At a glance
Market reach
- United States
- FDA recalls
What Shippert Medical Technologies Corp. makes
Shippert Medical Technologies Corp. manufactures single-use medical wipes and nasal packs for procedural preparation, including alcohol-impregnated instrument wipes and anatomical nasal packs with or without airways. Their portfolio also includes injectable nasal packs, deep-pressure massage devices like the Muscle Wand, and filtration systems such as the TISSU-TRANS and its associated tubing and syringe fill components.
The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. These items are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 595 devicesShowing 1-50 of 595
FDA recalls
FDA recall records list 15 recalls initiated by Shippert Medical Technologies Corp., the earliest on 2017-06-01 and the most recent on 2018-02-02. By recorded status: 8 terminated and 7 with another status. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 8
- 2018 7
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 2 Feb 2018 Z-1330-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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- 2 Feb 2018 Z-1331-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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- 2 Feb 2018 Z-1332-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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- 2 Feb 2018 Z-1333-2019 Class II Completed —
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- 2 Feb 2018 Z-1334-2019 Class II Completed —
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- 2 Feb 2018 Z-1335-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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- 2 Feb 2018 Z-1336-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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- 2 Feb 2018 Z-1330-2019 Class II Completed The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
2017
- 20 Oct 2017 Z-0170-2018 Class II Terminated Potential breach of sterility of the packaging.
- 1 Jun 2017 Z-3060-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3061-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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Show all 15 recalls
2017
- 1 Jun 2017 Z-3062-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3063-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3064-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3065-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3066-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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- 1 Jun 2017 Z-3062-2017 Class II Terminated Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
Frequently asked questions
How many devices does Shippert Medical Technologies Corp. have in the registry?
The registry currently lists 595 devices for Shippert Medical Technologies Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shippert Medical Technologies Corp.'s devices?
Among its 50 most recently registered devices, Shippert Medical Technologies Corp. has devices listed in FDA GUDID (50 devices).
What risk classes do Shippert Medical Technologies Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Shippert Medical Technologies Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Shippert Medical Technologies Corp.?
FDA recall records list 15 recalls initiated by Shippert Medical Technologies Corp., the most recent initiated on 2 Feb 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Shippert Medical Technologies Corp. in the registry?
The most recently registered devices listed for Shippert Medical Technologies Corp. include N/A 3-C-T60-TP-4X30, N/A 3-C-T60-MS-3x15, N/A 3-S-CL60-T and N/A 3-H-SB-BL-3X25.