Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 114
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- Libre Rio Continuous Glucose Monitoring System (K233861): indications, design and recorded evidenceRegulatory decision evidence
- Life Fast Set, Life Regular Set (K150559): indications, design and recorded evidenceRegulatory decision evidence
- Life Sensor Cardiac Monitor (K191331): indications, design and recorded evidenceRegulatory decision evidence
- Life Spine SIMPACT Sacroiliac Joint Fixation System (K201538): indications, design and recorded evidenceRegulatory decision evidence
- LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (K241324): indications, design and recorded evidenceRegulatory decision evidence
- Lifetech Cardio Model 8301 Temporary Pacemaker (K182839): indications, design and recorded evidenceRegulatory decision evidence
- LigaMend (K253695): indications, design and recorded evidenceRegulatory decision evidence
- LigaPASS (K172021): indications, design and recorded evidenceRegulatory decision evidence
- LigaPASS (K173506): indications, design and recorded evidenceRegulatory decision evidence
- LigaPASS 2.0 Ligament Augmentation System (K213659): indications, design and recorded evidenceRegulatory decision evidence
- Light Based Over The Counter Wrinkle Reduction (OHS) — FDA decisions, comparisons and evidenceFDA record research
- Light Based Over-The-Counter Hair Removal (OHT) — FDA decisions, comparisons and evidenceFDA record research
- Light Therapy System (M500, L6) (K251042): indications, design and recorded evidenceRegulatory decision evidence
- Light, Lymphedema Reduction, Low Energy (NZY) — FDA decisions, comparisons and evidenceFDA record research
- LightForce Orthodontic System (K222764): indications, design and recorded evidenceRegulatory decision evidence
- LightningWire Transseptal Puncture System (TPS) (K261745): indications, design and recorded evidenceRegulatory decision evidence
- Lim Precision Steerable TS, Steerable Sheath, Dilator (K202226): indications, design and recorded evidenceRegulatory decision evidence
- LimiFlex® Dynamic Sagittal Tether Instrument Set (K253374): indications, design and recorded evidenceRegulatory decision evidence
- Lingo Glucose System (K233655): indications, design and recorded evidenceRegulatory decision evidence
- Linshom Respiratory Monitoring Device (LRMD) (K190734): indications, design and recorded evidenceRegulatory decision evidence
- LipiFlow Thermal Pulsation System (K161357): indications, design and recorded evidenceRegulatory decision evidence
- LipiFlow Thermal Pulsation System (K192623): indications, design and recorded evidenceRegulatory decision evidence
- Lipofina Laser System (K143741): indications, design and recorded evidenceRegulatory decision evidence
- LiquID .051 LP Guide Catheter Extension (K243691): indications, design and recorded evidenceRegulatory decision evidence
- Liquid CO2-2 (LCO2-2) (K152085): indications, design and recorded evidenceRegulatory decision evidence
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