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18,004 catalysts · 4,728 grant · 3,603 8k filing · 2,593 approval · 1,945 device 510k · 1,575 device recall · 1,351 device pma
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18,004 catalysts · 4,728 grant · 3,603 8k filing · 2,593 approval · 1,945 device 510k · 1,575 device recall · 1,351 device pma
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: OCX. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: PNL. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: SFV. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional
Product code: EZD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SCR. Advisory committee: Ear, Nose, Throat. Type: Traditional
Supplement type: 30-Day Notice. Product code: MCM. Advisory committee: EN. Decision: OK30
Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: PJQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: Real-Time Process. Product code: PMP. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: NXW. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diameter 1.6 - 2.1mm, Model 06 0402 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7120 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 6101 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7150 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102 6160000-103 6160000-104 6160000-105 6160001-063 6160001-064 6160001-065 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms 3/19/26 updated to add B105P Patient Monitor 6160001-061 B125P Patient Monitor 6160001-062 B105M-C Patient Monitor 6160002-033 B105M-A Patient Monitor 6160000-113 B155M-A Patient Monitor 6160000-115 B125P-B Patient Monitor 6160002-022 B105M-B Patient Monitor 6160002-023 B125M-B Patient Monitor 6160002-024 B105M-OR Patient Monitor 6160000-143 B105M-OR Patient Monitor 6160000-144 B155M-OR Patient Monitor 6160000-145 — Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment. — Status: Ongoing
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms Updated 3/19 to add CARESCAPE ONE MBZ101 2087075-001 — Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment. — Status: Ongoing
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0009 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
CODMAN Disposable Perforator 11mm. Cranial Perforator. — Reason: Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution. — Status: Ongoing
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced Heparin, Model/Catalog Number: 06 0187 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fluoride; Gray Model/Catalog Number: 07 7340 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 502-104 - Calf Implant style 1 size 4 UDI-DI code: B490502104 502-105 - Calf Implant style 1 size 5 UDI-DI code: B490502105 502-106 - Calf Implant style 1 size 6 UDI-DI code: B490502106 502-201 - Calf Implant style 2 size 1 UDI-DI code: B490502201 502-303 - Calf Implant style 3 size 3 UDI-DI code: B490502303 502-304 - Calf Implant style 3 size 4 UDI-DI code: B490502304 — Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin and Plasma Separator Gel; Green Model/Catalog Number: 07 7221 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis — Reason: Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa. — Status: Ongoing
Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No — Reason: Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced. — Status: Ongoing
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026 — Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. — Status: Ongoing
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503 — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Lithium Heparin; Green Model/Catalog Number: 07 7251 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Untreated. Model 06 0199 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection or Alarms — Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment. — Status: Ongoing
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System. — Reason: Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product Description: A clear, plastic capillary blood collection tube coated with Heparin — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis — Reason: Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa. — Status: Ongoing
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502 — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs UDI-DI code: B4906006019 600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs UDI-DI code: B4906006039 600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs UDI-DI code: B4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs UDI-DI code: B49060060239 600-603 -Silicone Carving Implant Style 6 Size 3 UDI-DI code: B490600603 600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs UDI-DI code: B49060060339 600-604 - Silicone Carving Implant Style 6 Size 4 UDI-DI code: B490600604 600-605 - Silicone Carving Implant Style 6 Size 5 UDI-DI code: B490600605 600-801 - Silicone Carving Implant Style 8 Size 1 UDI-DI code: B490600801 600-803 - Silicone Carving Implant Style 8 Size 3 UDI-DI code: B490600803 600-804 - Silicone Carving Implant Style 8 Size 4 UDI-DI code: B490600804 Intended for Augmentation and reconstructive surgery. * Pending information — Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. — Status: Ongoing
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-1R01, revision S — Reason: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment. — Status: Ongoing
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick. — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 115 ¿L; Prepared with Balanced Heparin Model/Catalog Number: 06 0185 Product Description: A clear, plastic capillary blood collection tube — Reason: Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. — Status: Ongoing