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FDA SSED for PMA P910071, ADATOMED SILICONE OIL OP5000

USD 178.95
FDA 510(k) K873213, HICKMAN PLASTIC SUBCUTANEOUS PORT, by C.R. Bard, Inc.

FDA 510(k) K873213, HICKMAN PLASTIC SUBCUTANEOUS PORT, by C.

USD 89.0
FDA 510(k) K161354, MELODY, Remote Control System for Ultrasound Probe, by Adecho Tech

FDA 510(k) K161354, MELODY, Remote Control System for Ultras

USD 89.0

ANDA 211287: Approval Letter, Routing Sheet, CRL

USD 170.95
FDA 510(k) K941327, CROSSTEX SELF-SEALING STERILIZATION POUCH, by Cross Country Paper Products Corp.

FDA 510(k) K941327, CROSSTEX SELF-SEALING STERILIZATION POUC

USD 89.0
FDA 510(k) K960091, ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT, by Helix Diagnostics, Inc.

FDA 510(k) K960091, ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED

USD 89.0
FDA 510(k) K971418, CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER, by Chiron Diagnostics Corp.

FDA 510(k) K971418, CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINE

USD 89.0
FDA 510(k) K972706, CLINITEK MICROALBUMIN REAGENT STRIPS, by Bayer Corp.

FDA 510(k) K972706, CLINITEK MICROALBUMIN REAGENT STRIPS, by

USD 89.0
FDA 510(k) K001086, FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900, by Diagnostic Systems Laboratories, Inc.

FDA 510(k) K001086, FREE TESTOSTERONE ENZYME IMMUNOASSAY, MO

USD 89.0
FDA 510(k) K003987, URS-1K (KETONE TESST), by Teco Diagnostics

FDA 510(k) K003987, URS-1K (KETONE TESST), by Teco Diagnosti

USD 89.0
FDA 510(k) K003720, ANGEL OF WATER COLON HYDROTHERAPY SYSTEM, by Lifestream Purfication Systems, LLC

FDA 510(k) K003720, ANGEL OF WATER COLON HYDROTHERAPY SYSTEM

USD 89.0
FDA 510(k) K090413, A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC, by Bayer Healthcare, LLC

FDA 510(k) K090413, A1CNOW+ (10 TEST KIT, PROFESSIONAL USE)

USD 89.0
FDA 510(k) K161533, A1C EZ Glycohemoglobin Analysis System, by Biohermes Co., Ltd.

FDA 510(k) K161533, A1C EZ Glycohemoglobin Analysis System,

USD 89.0
FDA 510(k) K171392, ulrichINJECT CT motion, by Ulrich GmbH & Co. KG

FDA 510(k) K171392, ulrichINJECT CT motion, by Ulrich GmbH &

USD 2029.4
FDA 510(k) K221183, AEYE-DS, by Aeye Health, Inc.

FDA 510(k) K221183, AEYE-DS, by Aeye Health, Inc.

USD 788.63
FDA 510(k) K213037, IDx-DR v2.3, by Digital Diagnostics, Inc.

FDA 510(k) K213037, IDx-DR v2.3, by Digital Diagnostics, Inc

USD 723.25
FDA 510(k) K200667, EyeArt, by Eyenuk, Inc.

FDA 510(k) K200667, EyeArt, by Eyenuk, Inc.

USD 2111.47
FDA 510(k) K193053, Tina-quant Hemoglobin A1cDx Gen.3, by Roche Diagnostics Operations (Rdo)

FDA 510(k) K193053, Tina-quant Hemoglobin A1cDx Gen.3, by Ro

USD 89.0
FDA 510(k) K182651, HbA1c Advanced, by Beckman Coulter Ireland, Inc.

FDA 510(k) K182651, HbA1c Advanced, by Beckman Coulter Irela

USD 89.0

FDA Drug Approval, A086195, PROCTOFOAM HC

USD 227.95
FDA 510(k) K160907, DePuy Actis DuoFix Hip Prosthesis, by Depuy(Ireland)

FDA 510(k) K160907, DePuy Actis DuoFix Hip Prosthesis, by De

USD 478.43
FDA 510(k) K861985, 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX), by 3M Company

FDA 510(k) K861985, 3M BRAND MICROVASCULAR ANASTOMOTIC COUPL

USD 179.0
FDA 510(k) K040163, MICROVASCULAR ANASTOMOTIC DEVICE, by Synovis Micro Companies Alliance, Inc.

FDA 510(k) K040163, MICROVASCULAR ANASTOMOTIC DEVICE, by Syn

USD 571.63

FDA Drug Approval, N017381, SILVADENE

USD 404.41