Collection: Fast Track Requests
FDA documents available for fast-track requests typically delivered within 1 to 2 weeks. Our fast-track request service identifies previously requested and redacted documents for quick access.
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FDA 510(k), K070378, ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K032149, RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K052674, CONTACT LENS OPHTHALMODYNAMOMETER
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K992875, SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K202243, SkinPen Precision System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K021914, MICROPLEX COIL SYSTEMS (MCS)
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K200547, Traxcess 14 SELECT Guidewire
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K073377, ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K843909, TITANIUM HIP 1019
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K192268, Europa Pedicle Screw System
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K191906, MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K103122, C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K984188, AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K970824, MDX 2000, DIGITAL ANALYZER
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K043299, MEDLEY PCA MODULE, MODEL 8120
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K032147, SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K946168, IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K873884, IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K012383, GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K060479, MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K896393, CARDIAC COOLING JACKED, 16 CM, MODEL CJ-620
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K191006, EasiSlush
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K833112, TUBING FOR CARDIOPULMONARY BYPASS
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K896971, CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K896972, CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K896973, CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K863981, STERILIZATION WRAPS #620,624,648,640,636,630,612
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K002617, PERIFORM PERINEOMETRIC PROBE, MODEL 8300
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K023305, KEGELMASTER 2000
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K990041, UROSTYM BIOFEEDBACK AND STIMULATION PROBES
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K030086, PALACOS R BONE CEMENT WITH GENTAMICIN
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K202623, Novapak Nasal Sinus Packing and Stent
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K002256, ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K961509, INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K963187, MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD -
FDA 510(k), K940178, PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
Regular price $89.00 USDRegular priceUnit price / perSale price $89.00 USD