Collection: FDA 510(k)
FDA 510K documents available for fast-track requests typically delivered within 1 to 2 weeks. Publicly Available documents delivered within 24 business hours.
Use Search below to find the 510k you are looking for by:
- Device Name
- Manufacturer
- Device Classification Name
- Regulation Number
- Classification Product Code
- Date Received
- Decision Date
- Regulation Medical Specialty
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FDA 510(k), K042784, MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K041623, REUSABLE STERILCONTAINER FILTER MODEL #JK090
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042841, M2A/C2A ACETABULAR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042911, CEMENTEK LV
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042938, GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042657, VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K043557, MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050159, MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050338, MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050275, MODIFICATION TO: INION OTPS BIODEGRADABLE PIN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050344, LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042091, BIOLOX DELTA CERAMIC HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050225, HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K043555, SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050937, TRABECULAR METAL ACETABULAR REVISION SHELLS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051002, ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K042912, INTERX5000
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050273, FRESENIUS ART HEMOADSORPTION SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K050036, FES CYCLE ERGOMETER, MODEL RT300-S
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051411, ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051588, BIOLOX DELTA CERAMIC FEMORAL HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051664, SCAN300FP / RETROPAN (VDC)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052051, OMNI SPHINCTEROTOME
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K043465, 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K051980, DVT SCANNER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052260, SUPERDIMENSION/BRONCHUS 4.1
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052309, DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052718, V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052607, ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052852, SUPERDIMENSION/BRONCHUS PREMIUM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052596, MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052931, MODIFICATION TO VERTE-STACK SPINAL SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052257, VASCULAR SOLUTIONS TWIN-PASS DUAL ACCESS CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K053120, STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052396, OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K052289, DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE
Regular price $149.00 USDRegular priceUnit price / per