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ANDA 211287: Approval Letter, Routing Sheet, CRL
Regular price $124.74 USDRegular priceUnit price / per -
FDA 510(k), K000080, ASNIS III CANNULATED SCREW SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000281, WALLSTENT ENTERNAL PROSTHESIS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000365, ACCU-CHEK ADVANTAGE METER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000609, CARDTEL, MODEL NT-100
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000669, MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000795, RIGID GAS PERMEABLE CONTACT LENS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K000881, PERFADEX SOLUTION FOR ORGAN PRESERVATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001086, FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001122, PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001149, AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001217, INSIDE VIEW
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001275, RETCAM II
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001338, MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001520, ALPHA OMEGA DUAL COOLER-HEATER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001852, PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001960, RIGID GAS PERMEABLE CONTACT LENS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K001989, COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002095, SNAP MODEL 6
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002138, PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002255, LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002321, PAIN CARE 2000L
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002488, KELO-COTE TOPICAL GEL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002883, PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002892, FRSENIUS PD IQCARD CYCLER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002911, XSCAN32 TELERADIOLOGY SOFTWARE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002913, HEADBAND FOR BAHA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K002996, SYNERGY HA COATED POROUS FEMORAL STEMS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003028, CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003154, MIZAR, BASIS BE, SANDMAN DIGITAL
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003269, UNICONDYLAR INTERPOSITIONAL SPACER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003305, PEDIATRIC INGESTASCAN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003335, RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003337, HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003487, STIMATE N601 TENS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K003559, TCI (TINNITUS CONTROL INSTRUMENT)
Regular price $149.00 USDRegular priceUnit price / per