Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 87
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- GUM HYDRAL Dry Mouth Oral Gel, GUM HYDRAL Dry Mouth Oral Rinse, GUM HYDRAL Dry Mouth Oral Spray (K181134): indications, design and recorded evidenceRegulatory decision evidence
- H. PYLORI QUIK CHEK (K181379): indications, design and recorded evidenceRegulatory decision evidence
- HA Minuteman G3 MIS Fusion Plate (K151741): indications, design and recorded evidenceRegulatory decision evidence
- HA Minuteman G3-R MIS Fusion Plate (K163428): indications, design and recorded evidenceRegulatory decision evidence
- HAL for Medical Use (Lower Limb Type) (K171909): indications, design and recorded evidenceRegulatory decision evidence
- HALO (K200873): indications, design and recorded evidenceRegulatory decision evidence
- HALO AP Dx (K232833): indications, design and recorded evidenceRegulatory decision evidence
- HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops (K252941): indications, design and recorded evidenceRegulatory decision evidence
- HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor (K251967): indications, design and recorded evidenceRegulatory decision evidence
- HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap (K234050): indications, design and recorded evidenceRegulatory decision evidence
- HAMILTON-C3 (K201306): indications, design and recorded evidenceRegulatory decision evidence
- HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) (K183616): indications, design and recorded evidenceRegulatory decision evidence
- HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) (K180180): indications, design and recorded evidenceRegulatory decision evidence
- HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE (K132612): indications, design and recorded evidenceRegulatory decision evidence
- HARMONIC Focus Long Shears + Adaptive Tissue Technology (K151340): indications, design and recorded evidenceRegulatory decision evidence
- HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length (K160752): indications, design and recorded evidenceRegulatory decision evidence
- HARMONIC HOOK (K151136): indications, design and recorded evidenceRegulatory decision evidence
- HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation System (K171413): indications, design and recorded evidenceRegulatory decision evidence
- HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (K220875): indications, design and recorded evidenceRegulatory decision evidence
- HAtetracell-C Titanium Cervical IBF System (K231899): indications, design and recorded evidenceRegulatory decision evidence
- HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY (K141502): indications, design and recorded evidenceRegulatory decision evidence
- HBP7 Settable Hemostatic Bone Putty (K202363): indications, design and recorded evidenceRegulatory decision evidence
- HD Camera Head OLYMPUS CH-S200-08-LB (K261260): indications, design and recorded evidenceRegulatory decision evidence
- HEARTWAY POWER MOBILITY SCOOTER (K132855): indications, design and recorded evidenceRegulatory decision evidence
- HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (K222270): indications, design and recorded evidenceRegulatory decision evidence
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