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ANDA 211287: Approval Letter, Routing Sheet, CRL
Regular price $170.95 USDRegular priceUnit price / per -
FDA 510(k) K022983, BARDPORT X-PORT ISP PORT, C.R. BARD, INC.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K042145 READY-HEAT BLANKET
Regular price $415.84 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) K122831, VIDEO SYSTEM CENTER, OLYMPUS MEDICAL SYSTEMS CORP.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K122899, POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, C.R. BARD, INC.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K140503, FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER, THIRD PARTY REVIEW GROUP, LLC
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K163524, Vessel Dilator, Fetzer Medical GmbH & Co. KG
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K192869, SherpaPak Lung Preservation System , SherpaPak Liver Transport System, Northstar Biomedical Associates
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K200529, Orion, lnteracoustics A/S
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K202459, Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter, MEDIcept Inc.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K214115, MightySat -OTC, Masimo Corporation
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K221365, LapBox Tissue Containment Removal System, ProMedoss, Inc.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K230076, Enhanced AURORA™ Medical Diode System, and related accessories, Psoria-Shield, Inc.
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k) K231465, Q-Pad Test System, Hyman, Phelps & McNamara P.C.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K231850, QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments, Globus Medical Inc
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K791899, CYCLER SETS MOD. #5C4143, 5C4144, 5C4145, TRAVENOL LABORATORIES, S.A.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K803293, GUARDIAN PEEL POUCHES, KIMBERLY-CLARK CORP.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K873213, HICKMAN PLASTIC SUBCUTANEOUS PORT, C.R. BARD, INC.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K924250, PLASTIC LOW PROFILE SUBCUTANEOUS PORT, BARD ACCESS SYSTEMS, INC.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K953776, STERIKING STERILIZATION POUCHES & ROLLS, WIHURI OY
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K961825, ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493, BAXTER HEALTHCARE CORP.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K964066, DUAL SLIM PORT IMPLANTED PORT (0654970/0654940), C.R. BARD, INC.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K973827, KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATION, KIMBERLY-CLARK CORP.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k) K993953 OVES CERVICAL CAP
Regular price $136.44 USDRegular priceUnit price / per -
FDA 510(k), AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES, AVITA CORPORATION
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), CONDUIT Cages; FIBERGRAFT BG Putty, MCRA LLC
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), CPAP MASK, DEVILBISS HEALTH CARE, INC.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), CustomizedBone Service, Regulatory and Clinical Research Institute, Inc.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES, SUNRISE MEDICAL
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE), FRESENIUS MEDICAL CARE NORTH AMERICA
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), HEARTPORT THORACIC TROCAR, HEARTPORT, INC.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054, INSTRUMED INTERNATIONAL, INC.
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K000080, ASNIS III CANNULATED SCREW SYSTEM
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K000281, WALLSTENT ENTERNAL PROSTHESIS
Regular price $49.00 USDRegular priceUnit price / per -
FDA 510(k), K000365, ACCU-CHEK ADVANTAGE METER
Regular price $49.00 USDRegular priceUnit price / per