Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 204
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- Tubing, Long Term Support Greater Than 6 Hours (QWF) — FDA decisions, comparisons and evidenceFDA record research
- Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape (K201863): indications, design and recorded evidenceRegulatory decision evidence
- Tunneled Catheter Remover (ODY) — FDA decisions, comparisons and evidenceFDA record research
- Turbo-Flo PICC Sets (K161496): indications, design and recorded evidenceRegulatory decision evidence
- TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile (K190539): indications, design and recorded evidenceRegulatory decision evidence
- Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter (K212211): indications, design and recorded evidenceRegulatory decision evidence
- TxRx Knee 15 Flare MR Coil 1.5T (K162966): indications, design and recorded evidenceRegulatory decision evidence
- TxRx Knee 15 Flare MR Coil 3.0T (K163066): indications, design and recorded evidenceRegulatory decision evidence
- Tympanostomy Tubes (K232059): indications, design and recorded evidenceRegulatory decision evidence
- Type 5 Integrating Indicator for Steam (CSPN-15) (K242860): indications, design and recorded evidenceRegulatory decision evidence
- Tyrosine Phosphatase (Ia-2) Autoantibody Assay (OIF) — FDA decisions, comparisons and evidenceFDA record research
- U&U Indicator tape and strip (K171823): indications, design and recorded evidenceRegulatory decision evidence
- U2 Femoral Component, CR, Porous Coated, Additional Sizes (K150832): indications, design and recorded evidenceRegulatory decision evidence
- UL 1642 Sixth Edition September 29 2020 — FDA recognition transition and report handoffCompliance research
- UL 2054 Third Edition November 17 2021 — FDA recognition transition and report handoffCompliance research
- ULSPIRA TS Nitric Oxide Therapy System (K242374): indications, design and recorded evidenceRegulatory decision evidence
- ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE (K140949): indications, design and recorded evidenceRegulatory decision evidence
- ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K130004): indications, design and recorded evidenceRegulatory decision evidence
- ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM (K141584): indications, design and recorded evidenceRegulatory decision evidence
- ULTRASHAPE POWER SYSTEM (K160896): indications, design and recorded evidenceRegulatory decision evidence
- ULTRASHAPE SYSTEM (K141708): indications, design and recorded evidenceRegulatory decision evidence
- ULTepap Expiratory Positive Airway Pressure (EPAP) Device (K191728): indications, design and recorded evidenceRegulatory decision evidence
- UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle (K142553): indications, design and recorded evidenceRegulatory decision evidence
- UNIEXPERT 2 PLUS (K200944): indications, design and recorded evidenceRegulatory decision evidence
- UNIVATION (K131167): indications, design and recorded evidenceRegulatory decision evidence
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