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19,902 catalysts · 4,728 grant · 3,345 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
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19,902 catalysts · 4,728 grant · 3,345 8k filing · 2,785 device 510k · 2,724 approval · 2,000 device recall · 1,962 device pma
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery. — Reason: Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'. — Status: Ongoing
ZAP-X Radiosurgery System, Model: 300150 — Reason: If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table. — Status: Ongoing
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC010469; 6. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480; 7. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480A; 8. ADULT INTUBATION, Kit Number ACC010540; 9. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593A; 10. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593B; 11. INTUBATION TRAY, Kit Number DYNDA1847A; 12. INTUBATION TRAY (ADULT), Kit Number DYNJAA245A. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended. — Status: Ongoing
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices. — Reason: Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway. — Status: Ongoing
Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended. — Status: Ongoing
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery. — Reason: Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'. — Status: Ongoing
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. — Reason: Due to incorrect/lack of Unique Device Identifier (UDI) codes. — Status: Ongoing
Product code: BZE. Advisory committee: Anesthesiology. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: KRO. Advisory committee: Orthopedic. Type: Traditional
Product code: GWO. Advisory committee: Neurology. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: KRH. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: SECURA. Form: CAPSULE. Route: ORAL
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NVN. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 — Reason: Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles — Status: Ongoing
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631 — Reason: Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted — Status: Ongoing
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-DI code: 07350137520081 Inserter Adapter OTD REF 30-158 Model Number: 1004 UDI-DI code: 07350137520098 The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation. — Reason: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. — Status: Ongoing
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 — Reason: Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure — Status: Ongoing
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QYE. Advisory committee: Cardiovascular. Type: Traditional
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: QLX. Advisory committee: Microbiology. Type: Traditional
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION
Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPU. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR