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Approval Package — Approval Records & Labeling https://foiadocs.com/products/fda-drug-approval-package-augmentin-xr-nda-050785 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-augmentin-xr-nda-050785-approval-records.png?v=1789009497 FDA AUGMENTIN XR NDA 050785 Approval Package — Approval Records & Labeling https://foiadocs.com/products/fda-drug-approval-package-doryx-nda-050795 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-doryx-nda-050795-approval-records.png?v=1789009496 FDA DORYX NDA 050795 Approval Package — Reviews & Approval Records https://foiadocs.com/products/fda-drug-approval-package-iluvien-nda-201923 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-iluvien-nda-201923-approval-records.png?v=1789009496 FDA ILUVIEN NDA 201923 Approval Package — Reviews & Approval Records https://foiadocs.com/products/fda-drug-approval-package-dymista-nda-202236 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https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k112760-amsco-v-pro-max-low-temperature-sterilization-system.png?v=1791746006 FDA 510(k) K112760, AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM, by STERIS Corporation https://foiadocs.com/products/fda-510k-k120632-amsco-v-pro-1-lowplusmax-temperature-sterilization-system 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k120632-amsco-v-pro-1-lowplusmax-temperature-sterilization-system.png?v=1791745957 FDA 510(k) K120632, AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM, by STERIS Corporation https://foiadocs.com/products/fda-510k-k152113-biohpp-brecambiohpp 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k152113-biohpp-brecambiohpp.png?v=1791745895 FDA 510(k) K152113, BioHPP - breCAM.BioHPP, by Bredent GmbH & Co. KG https://foiadocs.com/products/fda-510k-k152829-visions-pv014p-rx-digital-ivus-catheter 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k152829-visions-pv014p-rx-digital-ivus-catheter.png?v=1791745837 FDA 510(k) K152829, Visions PV.014P RX Digital IVUS Catheter, by Volcano Corporation https://foiadocs.com/products/fda-510k-k160918-juvora-dental-disc-ceramill-peek-by-juvora 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k160918-juvora-dental-disc-ceramill-peek-by-juvora.png?v=1791745783 FDA 510(k) K160918, JUVORA Dental Disc, Ceramill PEEK by JUVORA, by Juvora https://foiadocs.com/products/fda-510k-k161384-lithoplasty-peripheral-balloon-dilatation-catheter-lithoplasty 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k161384-lithoplasty-peripheral-balloon-dilatation-catheter-lithoplasty.png?v=1791745717 FDA 510(k) K161384, Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable, by Shockwave Medical, Inc. https://foiadocs.com/products/fda-510k-k172754-v-pro-max-2-low-temperature-sterilization-system 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k172754-v-pro-max-2-low-temperature-sterilization-system.png?v=1791745666 FDA 510(k) K172754, V-PRO maX 2 Low Temperature Sterilization System, by STERIS Corporation https://foiadocs.com/products/fda-510k-k173256-system-1-endo-liquid-chemical-sterilant-processing-system 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k173256-system-1-endo-liquid-chemical-sterilant-processing-system.png?v=1791745598 FDA 510(k) K173256, System 1 endo Liquid Chemical Sterilant Processing System, by STERIS Corporation https://foiadocs.com/products/fda-510k-k181331-juvora-oyster-white-dental-disc-ceramill-peek-by-juvora-oyster 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k181331-juvora-oyster-white-dental-disc-ceramill-peek-by-juvora-oyster.png?v=1791745548 FDA 510(k) K181331, JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White, by Juvora, Ltd. https://foiadocs.com/products/fda-510k-k182827-system-1-endo-liquid-chemical-sterilant-processing-system-model 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k182827-system-1-endo-liquid-chemical-sterilant-processing-system-model.png?v=1791745489 FDA 510(k) K182827, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900, by STERIS Corporation https://foiadocs.com/products/fda-510k-k202345-flowtriever-retrievalaspiration-system 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k202345-flowtriever-retrievalaspiration-system.png?v=1791745411 FDA 510(k) K202345, FlowTriever Retrieval/Aspiration System, by Inari Medical https://foiadocs.com/products/fda-510k-k203024-c2-cryoballoon-catheter-pear-c2-cryoballoon-catheter-standard-c 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k203024-c2-cryoballoon-catheter-pear-c2-cryoballoon-catheter-standard-c.png?v=1791745323 FDA 510(k) K203024, C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge, by Pentax of America, Inc. https://foiadocs.com/products/fda-510k-k250096-felix-neuroai-system 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k250096-felix-neuroai-system.png?v=1791745242 FDA 510(k) K250096, Felix NeuroAI System, by Fasikl Incorporated https://foiadocs.com/products/fda-510k-k250356-mome-arc-wireless-ambulatory-ecg-monitoring-and-detection-syste 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k250356-mome-arc-wireless-ambulatory-ecg-monitoring-and-detection-syste.png?v=1791745172 FDA 510(k) K250356, MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000), by Infobionic, Inc. https://foiadocs.com/products/fda-510k-k123638-pekkton-ivory 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k123638-pekkton-ivory.png?v=1791745071 FDA 510(k) K123638, PEKKTON IVORY, by Cendres & Metaux SA https://foiadocs.com/products/fda-510k-k132725-juvora-dentqal-disc 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k132725-juvora-dentqal-disc.png?v=1791745010 FDA 510(k) K132725, JUVORA DENTQAL DISC, by Juvora https://foiadocs.com/products/fda-510k-k170102-pekkton-ivory 2026-10-12T11:58:56-05:00 daily https://cdn.shopify.com/s/files/1/0659/0677/0084/files/fda-510k-k170102-pekkton-ivory.png?v=1791744534 FDA 510(k) K170102, Pekkton Ivory, by Cendres+Metaux SA