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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) K002837, BIS ENGINE
Regular price $139.31 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) K033688, MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
Regular price $805.32 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) K050833, LECTRODE JUNCTION BOX, MODEL JE-921A
Regular price $392.19 USDRegular priceUnit price / per -
FDA 510(k) K053379, RELI-ON ONE STEP, ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc.
Regular price $221.31 USDRegular priceUnit price / per -
FDA 510(k) K080445, LION SE ONE STEP ORTHODONTIC ADHESIVE, by Classone Orthodontics, Inc.
Regular price $273.70 USDRegular priceUnit price / per -
FDA 510(k) K081472 | SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS
Regular price $148.00 USDRegular priceUnit price / per -
FDA 510(K) K093065, FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
Regular price $1,705.30 USDRegular priceUnit price / per -
FDA 510(K) K100434, CLAVE NEUTRON
Regular price $439.49 USDRegular priceUnit price / per -
FDA 510(K) K100442, FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM
Regular price $484.00 USDRegular priceUnit price / per -
FDA 510(K) K110277, RAPIDPOINT 405 NEONATAL BILIRUBIN
Regular price $1,147.51 USDRegular priceUnit price / per -
FDA 510(k) K110374 MAX PULSE SYSTEM
Regular price $194.52 USDRegular priceUnit price / per -
FDA 510(K) K110569, AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
Regular price $568.85 USDRegular priceUnit price / per -
FDA 510(k) K122831, VIDEO SYSTEM CENTER, OLYMPUS MEDICAL SYSTEMS CORP.
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(k) K122899, POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, C.R. BARD, INC.
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(K) K123769, ZX-I POWER ADD ON
Regular price $584.15 USDRegular priceUnit price / per -
FDA 510(K) K131686, INOMAX DSIR (DELIVERY SYSTEM)
Regular price $605.02 USDRegular priceUnit price / per -
FDA 510(K) K132792, ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHARPS CONTAINER
Regular price $191.03 USDRegular priceUnit price / per -
FDA 510(k) K140503, FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER, THIRD PARTY REVIEW GROUP, LLC
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(K) K142754, Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
Regular price $549.38 USDRegular priceUnit price / per -
FDA 510(K) K143213, INOmax DSIR Plus MRI
Regular price $477.16 USDRegular priceUnit price / per -
FDA 510(K) K150313, Ablation Confirmation
Regular price $617.47 USDRegular priceUnit price / per -
FDA 510(k) K152319, Auris Robotic Endoscopy System (ARES), by Auris Surgical Robotics, Inc.
Regular price $887.78 USDRegular priceUnit price / per -
FDA 510(K) K153302 COFLEX-IF CLEARED 09/08/2016
Regular price $654.79 USDRegular priceUnit price / per -
FDA 510(k) K160127 iCodeConnect Submission by 3B MEDICAL, INC.
Regular price $733.44 USDRegular priceUnit price / per -
FDA 510(k) K163524, Vessel Dilator, Fetzer Medical GmbH & Co. KG
Regular price $89.00 USDRegular priceUnit price / per -
FDA 510(K) K171401, ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
Regular price $322.33 USDRegular priceUnit price / per -
FDA 510(k) K172431 Submission – Full file, including Master File, submissions, responses, and review memos.
Regular price $2,799.39 USDRegular priceUnit price / per -
FDA 510(k) K172959, PeraServer and PeraTrend
Regular price $602.23 USDRegular priceUnit price / per -
FDA 510(k) K191360 i-STAT CHEM8+ Cartridge with the i-STAT 1 System
Regular price $3,500.00 USDRegular priceUnit price / per$3,761.00 USDSale price $3,500.00 USDSale -
FDA 510(k) K191402, Heater-Cooler System 3T, by Livanova Deutschland, GmbH
Regular price $3,500.00 USDRegular priceUnit price / per