Cruxi research & evidence
FDA 510(k) Submission Services evidence guides — page 150
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- Pedicle Screw Placement Guide (PQC) — FDA decisions, comparisons and evidenceFDA record research
- PeekMed web (K252452): indications, design and recorded evidenceRegulatory decision evidence
- PeekMed web (K252856): indications, design and recorded evidenceRegulatory decision evidence
- Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) (K230283): indications, design and recorded evidenceRegulatory decision evidence
- Peleton Universal Single Use Power System and Attachments (K240071): indications, design and recorded evidenceRegulatory decision evidence
- Pen Injector (K240774): indications, design and recorded evidenceRegulatory decision evidence
- Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) (K262427): indications, design and recorded evidenceRegulatory decision evidence
- Pentacam AXL Wave (K201724): indications, design and recorded evidenceRegulatory decision evidence
- Penumbra 3D Revascularization Device (K162901): indications, design and recorded evidenceRegulatory decision evidence
- Penumbra System (Reperfusion Catheter RED 43) (K222808): indications, design and recorded evidenceRegulatory decision evidence
- Penumbra System (Reperfusion Catheter RED 62) (K203440): indications, design and recorded evidenceRegulatory decision evidence
- Penumbra System (Reperfusion Catheter RED 72) (K211654): indications, design and recorded evidenceRegulatory decision evidence
- Penumbra System (Reperfusion Catheter RED 72) (K242104): indications, design and recorded evidenceRegulatory decision evidence
- Penumbra System 110 Aspiration Tubing (K151623): indications, design and recorded evidenceRegulatory decision evidence
- Penumbra System ACE 68 Reperfusion Catheter (K161064): indications, design and recorded evidenceRegulatory decision evidence
- Penumbra System ACE 68 Reperfusion Catheter (K161640): indications, design and recorded evidenceRegulatory decision evidence
- Pepper EMS Training System (K233770): indications, design and recorded evidenceRegulatory decision evidence
- PeraServer and PeraTrend (K172959): indications, design and recorded evidenceRegulatory decision evidence
- Peralta Stone Removal Catheter (K190492): indications, design and recorded evidenceRegulatory decision evidence
- Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set (K250824): indications, design and recorded evidenceRegulatory decision evidence
- Percutaneous Introducer (K200624): indications, design and recorded evidenceRegulatory decision evidence
- Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set (K181735): indications, design and recorded evidenceRegulatory decision evidence
- Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position (OMF) — FDA decisions, comparisons and evidenceFDA record research
- Peregrine Endoscopy System (K202727): indications, design and recorded evidenceRegulatory decision evidence
- Perfect-O Ostial Positioning Catheter (K260289): indications, design and recorded evidenceRegulatory decision evidence
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