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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma
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2,000 catalysts · 18,987 approval · 5,000 device 510k · 4,876 phase readout · 4,728 grant · 2,415 8k filing · 2,000 device pma
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ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemosafeLock Connecter REF: KL-FNU3 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E. — Reason: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment. — Status: Ongoing
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Port REF: CL2100 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Bag Spike REF: CL-10 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ChemoLock Bag Spike, 01 units REF: CL-10-10 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 — Reason: Port weld of drug transfer device may separate or break during use and potentially result in a leak. — Status: Ongoing
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. — Reason: Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. — Status: Ongoing
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I — Reason: Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz). — Status: Ongoing
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System) — Reason: Potential that the measured value may be smaller than the actual area. — Status: Ongoing
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable — Reason: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. — Status: Ongoing
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BIPOLAR HEAD 47MM 18140 BIPOLAR HEAD 48MM 18141 BIPOLAR HEAD 49MM 18142 BIPOLAR HEAD 50MM 18143 BIPOLAR HEAD 51MM 18144 BIPOLAR HEAD 52MM 18145 BIPOLAR HEAD 53MM 18146 BIPOLAR HEAD 54MM 18147 BIPOLAR HEAD 55MM 18148 BIPOLAR HEAD 56MM 18149 BIPOLAR HEAD 57MM 18150 BIPOLAR HEAD 58MM 18151 BIPOLAR HEAD 59MM 18152 BIPOLAR HEAD 60MM — Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. — Status: Ongoing
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9 — Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. — Status: Ongoing
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable — Reason: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. — Status: Ongoing
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 — Reason: The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices. — Status: Ongoing
BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36 — Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. — Status: Ongoing
BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT — Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. — Status: Ongoing
BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 ENDO SH 43 10191 ENDO SH 45 10192 ENDO SH 47 10193 ENDO SH 49 10194 ENDO SH 51 10195 ENDO SH 53 10196 ENDO SH 55 — Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted. — Status: Ongoing