Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 158
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- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive (OIY) — FDA decisions, comparisons and evidenceFDA record research
- Prosthesis, Rib Replacement (MDI) — FDA decisions, comparisons and evidenceFDA record research
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented (PAO) — FDA decisions, comparisons and evidenceFDA record research
- Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set (K162181): indications, design and recorded evidenceRegulatory decision evidence
- Protek Solo 24 Fr Venous Cannula Set (K162214): indications, design and recorded evidenceRegulatory decision evidence
- ProtekDuo Mini Veno-Venous Cannula Set (K181150): indications, design and recorded evidenceRegulatory decision evidence
- Provident II Hip Stems (K201733): indications, design and recorded evidenceRegulatory decision evidence
- Proxeo ULTRA (PB-510, PB-520 and PB-530) (K223173): indications, design and recorded evidenceRegulatory decision evidence
- Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (K212952): indications, design and recorded evidenceRegulatory decision evidence
- Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair (K201228): indications, design and recorded evidenceRegulatory decision evidence
- Pulmogine Vibrating Mesh Nebulizer (K202171): indications, design and recorded evidenceRegulatory decision evidence
- Pulmonary Hypertension Machine Learning-Based Notification Software (SAT) — FDA decisions, comparisons and evidenceFDA record research
- Pulmonex II Xenon System (132-503) (K253942): indications, design and recorded evidenceRegulatory decision evidence
- Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 (K170111): indications, design and recorded evidenceRegulatory decision evidence
- Pulse Oximeter (MD300C228) (K232975): indications, design and recorded evidenceRegulatory decision evidence
- Pulse Oximeter(Model OHT60,OXH78) (K230277): indications, design and recorded evidenceRegulatory decision evidence
- Pump In Style® Pro+ (K253498): indications, design and recorded evidenceRegulatory decision evidence
- PuraStat (K222481): indications, design and recorded evidenceRegulatory decision evidence
- PuraStat (K242250): indications, design and recorded evidenceRegulatory decision evidence
- PuraStat-GI (K210098): indications, design and recorded evidenceRegulatory decision evidence
- PuraStat-RM (K261504): indications, design and recorded evidenceRegulatory decision evidence
- Pure Flow External Counter-Pulsation Device (K173483): indications, design and recorded evidenceRegulatory decision evidence
- Purema® H Hemoconcentrator (EtO Sterilized) (K232171): indications, design and recorded evidenceRegulatory decision evidence
- Purgo (K213753): indications, design and recorded evidenceRegulatory decision evidence
- Puritan Bennett Cuff Pressure Manager (K202874): indications, design and recorded evidenceRegulatory decision evidence
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