Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 115
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- LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm (K150898): indications, design and recorded evidenceRegulatory decision evidence
- LithoVue Elite Digital Flexible Ureteroscope System (K261153): indications, design and recorded evidenceRegulatory decision evidence
- LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500) (K241598): indications, design and recorded evidenceRegulatory decision evidence
- LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) (K252703): indications, design and recorded evidenceRegulatory decision evidence
- Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (K161384): indications, design and recorded evidenceRegulatory decision evidence
- Little Wave Arc; Little Wave Flip (K223533): indications, design and recorded evidenceRegulatory decision evidence
- Livi Device (K252005): indications, design and recorded evidenceRegulatory decision evidence
- Llis, Vittra APS (K191306): indications, design and recorded evidenceRegulatory decision evidence
- LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System (K200793): indications, design and recorded evidenceRegulatory decision evidence
- Lollipop BiteBlock (K200652): indications, design and recorded evidenceRegulatory decision evidence
- Longeviti PorousFit implant (K211514): indications, design and recorded evidenceRegulatory decision evidence
- Longterm NPWT Foam Dressing Kit (K182458): indications, design and recorded evidenceRegulatory decision evidence
- Loss of Pulse Detection (K242967): indications, design and recorded evidenceRegulatory decision evidence
- Low Dead Space Piston Syringe (QNQ) — FDA decisions, comparisons and evidenceFDA record research
- Low Power Electrosurgical Devices For Skin Lesion Destruction (QVJ) — FDA decisions, comparisons and evidenceFDA record research
- Lubricant, Personal (NUC) — FDA decisions, comparisons and evidenceFDA record research
- Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible (PEB) — FDA decisions, comparisons and evidenceFDA record research
- Lubricating Jelly (K142473): indications, design and recorded evidenceRegulatory decision evidence
- Lucent® XP (K234150): indications, design and recorded evidenceRegulatory decision evidence
- Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle (K241821): indications, design and recorded evidenceRegulatory decision evidence
- Luma Wrap (K142416): indications, design and recorded evidenceRegulatory decision evidence
- Lumbar Expandable lnterbody Spacers -Additional Indications/Implants (K221894): indications, design and recorded evidenceRegulatory decision evidence
- Lumen 155-SF (K223911): indications, design and recorded evidenceRegulatory decision evidence
- LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape)) (K232615): indications, design and recorded evidenceRegulatory decision evidence
- LumiVy Lumbar IBF System (K233807): indications, design and recorded evidenceRegulatory decision evidence
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