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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
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15,048 catalysts · 3,603 8k filing · 2,723 grant · 2,426 approval · 1,714 device 510k · 1,264 device recall · 1,172 device pma
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I — Reason: The nasal feeding tube may be occluded — Status: Ongoing
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6; — Reason: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge. — Status: Ongoing
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; — Reason: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge. — Status: Ongoing
Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract. — Reason: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton. — Status: Ongoing
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081 — Reason: Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia. — Status: Ongoing
Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I — Reason: The nasal feeding tube may be occluded — Status: Ongoing
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS NY. Form: CAPSULE. Route: ORAL
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GILEAD SCIENCES INC. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: HIKMA. Form: TABLET. Route: ORAL
Sponsor: SPECGX LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: TARO. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: L PERRIGO CO. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: SQ INNOVATION. Form: SOLUTION. Route: SUBCUTANEOUS
Product code: NQQ. Advisory committee: Radiology. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: KGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IMG. Advisory committee: Physical Medicine. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional
Supplement type: 30-Day Notice. Product code: MKT. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: OYB. Advisory committee: MI. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: OCM. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: MIH. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: OYB. Advisory committee: MI. Decision: OK30
SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600 — Reason: Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while the device is running on battery power, the SimplyGo Mini will shut down and stop providing oxygen to the user. This may happen at a temperature within the specified operating temperature range of the SimplyGo Mini. — Status: Ongoing
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay — Reason: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. — Status: Ongoing
Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01. — Reason: Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management. — Status: Ongoing
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay — Reason: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. — Status: Ongoing
GM85 Digital Mobile X-ray imaging System; Model Number: GM85; — Reason: The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue. — Status: Ongoing
Sponsor: SANOFI AVENTIS US. Form: INJECTABLE. Route: INJECTION
Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL
Sponsor: SANOFI AVENTIS US. Form: CAPSULE. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: AURINIA. Form: CAPSULE. Route: ORAL
Sponsor: SUMITOMO PHARMA AM. Form: TABLET. Route: ORAL
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. — Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity — Status: Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL). — Reason: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns — Status: Ongoing
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06. — Reason: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity — Status: Ongoing