Degania Silicone , Ltd.
Degania Silicone , Ltd. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2026, with 43 FDA device recalls on record.
Top product codes for Degania Silicone , Ltd.
FDA recalls by Degania Silicone , Ltd.
10 most recent of 43- Z-0809-2020 — Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
- Z-2265-2019 — Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
- Z-2260-2019 — Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
- Z-2264-2019 — Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
- Z-2261-2019 — Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
- Z-2267-2019 — Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
- Z-2262-2019 — Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
- Z-2263-2019 — Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
- Z-2266-2019 — Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
- Z-2759-2018 — Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Degania Silicone , Ltd.
- K254170 — Percutaneous Endoscopic Gastrostomy (PEG) Kit
- K233591 — Stylus
- K152246 — Aquarius Stoma Measuring Device
- K143378 — AQUARIUS Gastrostomy Replacement Tube
- K141753 — AQUARIUS NASAL FEEDING TUBE
- K141631 — AQUARIUS EXTENSION FEEDING SET
- K132686 — AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE
- K131020 — TEMPERATURE SENSOR CATHETER
- K122030 — LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
- K103371 — COUDE/ OR TIEMANN
- K070124 — GASTROSTOMY REPLACEMENT TUBE, MODEL 253
- K063442 — ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR
- K981956 — DEGANIA SILICONE IDENTI LOOPS
- K971482 — DEGANIA SILICONE SIL-K
- K964547 — DEGANIA SILICONE INDENTI LOOPS
- K953864 — SILCLEAR TUBING (MODIFICATION)
- K943992 — SILCLEAR TUBING
- K914701 — SIL-K
- K875092 — DEGANIA SILICONE TOURNIQUET
Data sourced from openFDA. This site is unofficial and independent of the FDA.