Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 112
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- LIPIVIEW OCULAR SURFACE INTERFEROMETER (K122481): indications, design and recorded evidenceRegulatory decision evidence
- LIXI (LXOSFM1) (K253662): indications, design and recorded evidenceRegulatory decision evidence
- LOCI Total Vitamin D Total Assay, LOCI VITD CAL (K162298): indications, design and recorded evidenceRegulatory decision evidence
- LOGIQ E10s (K251963): indications, design and recorded evidenceRegulatory decision evidence
- LOGIQ Focus (K261835): indications, design and recorded evidenceRegulatory decision evidence
- LOWTEM Crystal 120 (K231893): indications, design and recorded evidenceRegulatory decision evidence
- LT Antibacterial Foam with Silver Dressing (K254246): indications, design and recorded evidenceRegulatory decision evidence
- LTM-Perforated Surgical Mesh (K150712): indications, design and recorded evidenceRegulatory decision evidence
- LUCAS 3 Chest Compression System (K161768): indications, design and recorded evidenceRegulatory decision evidence
- LUMENVU CATHETER GUIDANCE SYSTEM (K093510): indications, design and recorded evidenceRegulatory decision evidence
- LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators (K142895): indications, design and recorded evidenceRegulatory decision evidence
- LUNA 3D (K232031): indications, design and recorded evidenceRegulatory decision evidence
- LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) (K242856): indications, design and recorded evidenceRegulatory decision evidence
- LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (K223360): indications, design and recorded evidenceRegulatory decision evidence
- LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US (K193473): indications, design and recorded evidenceRegulatory decision evidence
- LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) (K232597): indications, design and recorded evidenceRegulatory decision evidence
- LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) (K202241): indications, design and recorded evidenceRegulatory decision evidence
- Labcorp Fentanyl Urine Visual Test (K252684): indications, design and recorded evidenceRegulatory decision evidence
- LaborView LV1000 (K142583): indications, design and recorded evidenceRegulatory decision evidence
- Laboratorios Biogalenic Sterile Water for Inhalation, USP (K242717): indications, design and recorded evidenceRegulatory decision evidence
- Laminar P1 (LDH-HW-001) (K242487): indications, design and recorded evidenceRegulatory decision evidence
- Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) (K220475): indications, design and recorded evidenceRegulatory decision evidence
- LaparoLight Veress Needle (K171139): indications, design and recorded evidenceRegulatory decision evidence
- Laparoscope, General & Plastic Surgery, Reprocessed (NLM) — FDA decisions, comparisons and evidenceFDA record research
- Lapidus Screw Kit (K262075): indications, design and recorded evidenceRegulatory decision evidence
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