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1002FDAA2405: FDA Approval BLA 125062/674
Regular price $56.00 USDRegular priceUnit price / per -
Adverse Events: Elevidys (Delandistrogene Moxeparvovec)
Regular price $77.94 USDRegular priceUnit price / per -
Adverse Events: Syfovre
Regular price $413.06 USDRegular priceUnit price / per -
ANDA -- 219115 -- Bioequivalence Review (Dexlansoprazole Delayed-Release Capsules)
Regular price $376.89 USDRegular priceUnit price / per -
ANDA 211287: Approval Letter, Routing Sheet, CRL
Regular price $170.95 USDRegular priceUnit price / per -
Approval Routing Summary for ANDA # 213719 (Zydus)
Regular price $168.94 USDRegular priceUnit price / per -
FDA 510(k) Internal Review Files, K121057, COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
Regular price $64.94 USDRegular priceUnit price / per -
FDA 510(k) K000471, FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT, by Future Diagnostics B.V.
Regular price $175.00 USDRegular priceUnit price / per -
FDA 510(k) K000655, PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE, by Ahava Stein
Regular price $419.04 USDRegular priceUnit price / per -
FDA 510(k) K002028, BRAVO PH MONITORING SYSTEM, by Endonetics, Inc.
Regular price $685.26 USDRegular priceUnit price / per -
FDA 510(k) K002456, MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992, by Becton Dickinson Vacutainer Systems
Regular price $477.30 USDRegular priceUnit price / per -
FDA 510(k) K002837, BIS ENGINE
Regular price $139.31 USDRegular priceUnit price / per -
FDA 510(k) K004006, SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER, by Lumenis, Inc.
Regular price $1,533.35 USDRegular priceUnit price / per -
FDA 510(k) K004028, ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING, by Maersk Medical, Ltd.
Regular price $887.78 USDRegular priceUnit price / per -
FDA 510(k) K011666, CHILLIT, by Heatshield, Inc.
Regular price $221.31 USDRegular priceUnit price / per -
FDA 510(k) K021550, LUMENIS SELECTA DUET, by Ellex Medical Pty, Ltd.
Regular price $1,063.19 USDRegular priceUnit price / per -
FDA 510(k) K022357, TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815, by Boston Scientific, Target
Regular price $826.30 USDRegular priceUnit price / per -
FDA 510(k) K022983, BARDPORT X-PORT ISP PORT, C.R. BARD, INC.
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k) K023706, ULTROID HEMORRHOID MANAGEMENT SYSTEM, by Ultroid, LLC
Regular price $477.30 USDRegular priceUnit price / per -
FDA 510(k) K030315, MODIFICATION TO ULTROID HEMORRHOID MANAGEMENT SYSTEM, by Ultroid, LLC
Regular price $419.04 USDRegular priceUnit price / per -
FDA 510(k) K031099, SORB+HISORB+CARTRIDGE, by Renal Solutions, Inc.
Regular price $1,028.83 USDRegular priceUnit price / per -
FDA 510(k) K031649, SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES, by Fink Engineering Pty, Ltd.
Regular price $273.70 USDRegular priceUnit price / per -
FDA 510(k) K031891, VIRTUOSAPH, by Terumo Cardiovascular Systems Corp.
Regular price $737.70 USDRegular priceUnit price / per -
FDA 510(k) K031949, TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75, by Baylis Medical Co., Inc.
Regular price $273.70 USDRegular priceUnit price / per -
FDA 510(k) K032688, COLONOSIGHT MODEL 510B, by Sightline Technologies , Ltd.
Regular price $341.30 USDRegular priceUnit price / per -
FDA 510(k) K032716, PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE), by Portex , Ltd.
Regular price $341.30 USDRegular priceUnit price / per -
FDA 510(k) K032958, PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000, by United Medical Systems, Inc.
Regular price $1,106.59 USDRegular priceUnit price / per -
FDA 510(K) K033688, MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
Regular price $805.32 USDRegular priceUnit price / per -
FDA 510(k) K040047, POLYGRAFT BGS; BONE GRAFT SUBSTITUTE, by Osteobiologics, Inc.
Regular price $314.26 USDRegular priceUnit price / per -
FDA 510(k) K042075, QUILL SYNTHETIC ABSORBABLE BARBED SUTURE, by Quill Medical, Inc.
Regular price $509.85 USDRegular priceUnit price / per -
FDA 510(k) K042145 READY-HEAT BLANKET
Regular price $415.84 USDRegular priceUnit price / per -
FDA 510(K) K042384, EUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
Regular price $578.59 USDRegular priceUnit price / per -
FDA 510(k) K050753, STRYKER DISCMONITOR, by Stryker Instruments
Regular price $540.59 USDRegular priceUnit price / per -
FDA 510(K) K050833, LECTRODE JUNCTION BOX, MODEL JE-921A
Regular price $392.19 USDRegular priceUnit price / per -
FDA 510(k) K051587, TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470, by Tracoe Medical GmbH
Regular price $509.85 USDRegular priceUnit price / per -
FDA 510(k) K051656, OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM, by Osteobiologics, Inc.
Regular price $393.69 USDRegular priceUnit price / per