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[Recalled] Trial Tampon Box; Model Number: FG-TMP-REF04050504; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Trial Tampon Box; Model Number: FG-TMP-REF04050504; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance. Issued 2025-02-17.

[Recalled] Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance.

[Recalled] Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance.

[Recalled] Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Initiation 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-IB09090909; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance.

[Recalled] 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for 9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearanc

[Recalled] Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Initiation 36 Coated Regular Tampons; Model Number: FG-TMP-MM-IB36000000; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance

[Recalled] 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for 18 Coated Regular Tampons; Model Number: FG-TMP-REF18000000; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance. Issued 2025

[Recalled] Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Refill 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-REFRF; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance. I

[Recalled] 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for 9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k)

[Recalled] Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Refill 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-REF18001800; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks

[Recalled] Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance. Is

[Recalled] Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one

FDA recall notice for Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5)

[Recalled] Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-552

FDA recall notice for Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50

[Recalled] NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I — Fluctuations may be more likely to occur if the total flow through the device s… | FDA 2025-09-09

FDA recall notice for NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I (NOXBOX LTD). Reason: Fluctuations may be more likely to occur if the total

[Recalled] The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement. — Vision RT is informing customers of an omission identified in the Instructions… | FDA 2025-0

FDA recall notice for The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement. (Vi

[Recalled] Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating

FDA recall notice for Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTH

[Recalled] Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide

FDA recall notice for Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The Nov

[Recalled] Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heat

FDA recall notice for Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and Nov

[Recalled] Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide

FDA recall notice for Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The Nov

[Recalled] HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator) — Due to a component manufacturing issue, Automated External Defibrillator may no… | FDA 2025-06-30

FDA recall notice for HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator) (HeartSin