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), K902149, FRESENIUS/DELMED 90/2 PERITONEAL DIALYSIS SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K901337, HILAL EMBOLIZATION MICROCOIL(TM)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K910124, LOW VISION ENHANCEMENT SYSTEM (LVES)
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K910898, SURGICA(TM) H
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K904573, PENTAX ULTRASOUND ENDOSCOPE, MODEL FG-32UA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K910602, HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K910769, SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K912438, MODELS 5,8,20,20S ARGON ION LASERS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K910272, HGM COMBINATION ND:YAG & SOLID STATE GREEN
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K912628, AIR ARGON ION LASERS VARIOUS MODELS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K913569, COMPAC A, ELITE A, ELITE A PLUS, SURGICA A
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K913083, BI-TEMP TEMPERATURE MONITOR TM-201D
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K911144, MF-500, MODIFICATION
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K922457, AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K921300, MODEL PC ARGON ION LASER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K923160, 3DSCOPE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K925794, TRACE MICROPROTEIN REAGENT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K930622, AMPLATZ GUIDEWIRES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K931374, AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K935674, LIFEPAK 9 DEFIBRILLATOR/MONITOR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K931621, ACUFEX PRO-PAC AND ISO-PAC
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K933121, MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K914145, DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K931588, SUTTER PROXIMAL INTERPHALANGEAL JOINT
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K935442, MAHE INSTRUMENTS
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K940187, ENVOY GUIDING CATHETER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K933094, INSUFFLATOR TUBING KIT W/FILTER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942044, BARD ENDOSCOPIC OVERTUBE
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K933768, COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942533, NOVALENS/NOVAWET PERCEPTION AND VANGUARD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942819, TROCAR WITH SHIELD
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942054, SHARPS-TAINER
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K941691, REVO ROTATOR CUFF REPAIR SYSTEM
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942903, SHARPS-TAINER SMALL OPENING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942901, SHARPS-TAINER LARGE OPENING
Regular price $149.00 USDRegular priceUnit price / per -
FDA 510(k), K942821, MAHE INSTRUMENTS
Regular price $149.00 USDRegular priceUnit price / per