Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 88
Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.
Compare FDA 510(k) Submission Services providers- HEDRON Cervical Spacers (HEDRON C-MIS Spacer) (K253876): indications, design and recorded evidenceRegulatory decision evidence
- HEMO-Bandage (K151204): indications, design and recorded evidenceRegulatory decision evidence
- HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) (K132883): indications, design and recorded evidenceRegulatory decision evidence
- HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM (K110031): indications, design and recorded evidenceRegulatory decision evidence
- HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System (K252018): indications, design and recorded evidenceRegulatory decision evidence
- HFD100 ROCKER ARM ACCESSORY (K141950): indications, design and recorded evidenceRegulatory decision evidence
- HI-TORQUE InfilTrac Guide Wire Family (K193126): indications, design and recorded evidenceRegulatory decision evidence
- HI-TORQUE PROCEED Guide Wire Family (K201834): indications, design and recorded evidenceRegulatory decision evidence
- HICP200 Patient/Monitor Interconnect Cable (K161010): indications, design and recorded evidenceRegulatory decision evidence
- HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx (K220685): indications, design and recorded evidenceRegulatory decision evidence
- HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream (K192123): indications, design and recorded evidenceRegulatory decision evidence
- HILINE Fixation System (K230565): indications, design and recorded evidenceRegulatory decision evidence
- HIT Clear Aligner (K210613): indications, design and recorded evidenceRegulatory decision evidence
- HIVOX Spopad EMS SP-911, SP-921 (K192264): indications, design and recorded evidenceRegulatory decision evidence
- HOME ACCESS AIC TEST (K141944): indications, design and recorded evidenceRegulatory decision evidence
- HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305) (K261438): indications, design and recorded evidenceRegulatory decision evidence
- HP Tissue Matrix (K142326): indications, design and recorded evidenceRegulatory decision evidence
- HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux (K161394): indications, design and recorded evidenceRegulatory decision evidence
- HS SutureTape (K153307): indications, design and recorded evidenceRegulatory decision evidence
- HSW Resection Instruments (K173070): indications, design and recorded evidenceRegulatory decision evidence
- HWJECT Auto-disable syringe (K234024): indications, design and recorded evidenceRegulatory decision evidence
- HYALEX® MTP Hemiarthroplasty Implant (K250074): indications, design and recorded evidenceRegulatory decision evidence
- HYDROS Robotic System (HY1000);HYDROS Handpiece (HH1000);HYDROS TRUS Probe (HU1000) (K260723): indications, design and recorded evidenceRegulatory decision evidence
- Habib EndoHPB (K180165): indications, design and recorded evidenceRegulatory decision evidence
- Habib EndoHPB (K231533): indications, design and recorded evidenceRegulatory decision evidence
Page 88 of 228