Cruxi research & evidence

Biocompatibility Testing (ISO 10993 Program) evidence guides — page 21

Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.

• Milagro / Milagro Advance Interference Screw (K143660): indications, design and recorded evidenceRegulatory decision evidence
• Milli Vaginal Dilator (K220035): indications, design and recorded evidenceRegulatory decision evidence
• Millipede 088 Access Catheter (K214048): indications, design and recorded evidenceRegulatory decision evidence
• MiniGuard Arterial Safety Valve (K182442): indications, design and recorded evidenceRegulatory decision evidence
• Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” (K161067): indications, design and recorded evidenceRegulatory decision evidence
• Mochida Nerve Cuff (K233322): indications, design and recorded evidenceRegulatory decision evidence
• Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented (K190533): indications, design and recorded evidenceRegulatory decision evidence
• Montage Flowable Settable, Resorbable Bone Paste (K232771): indications, design and recorded evidenceRegulatory decision evidence
• Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste (K231386): indications, design and recorded evidenceRegulatory decision evidence
• Morrison Steerable Needle (K150625): indications, design and recorded evidenceRegulatory decision evidence
• MuCover (proposed name) Oral Wound Dressing (K253816): indications, design and recorded evidenceRegulatory decision evidence
• MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) (K203673): indications, design and recorded evidenceRegulatory decision evidence
• N22 Offset Humeral Head (K262173): indications, design and recorded evidenceRegulatory decision evidence
• NC TREK NEO Coronary Dilatation Catheter (K220634): indications, design and recorded evidenceRegulatory decision evidence
• NEUROMARK System (NMK00301) (K261833): indications, design and recorded evidenceRegulatory decision evidence
• NEXA Negative Pressure Wound Therapy System (K162610): indications, design and recorded evidenceRegulatory decision evidence
• NEXTSTEP RETROGRADE (K130192): indications, design and recorded evidenceRegulatory decision evidence
• NIOX VERO AIRWAY INFLAMMATION MONITOR (K133898): indications, design and recorded evidenceRegulatory decision evidence
• NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE (K093985): indications, design and recorded evidenceRegulatory decision evidence
• NOVA RESIN dual cure, self adhesive resin cement (K213609): indications, design and recorded evidenceRegulatory decision evidence
• NUSTAT, NUSTAT XR (K142363): indications, design and recorded evidenceRegulatory decision evidence
• Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits (K183579): indications, design and recorded evidenceRegulatory decision evidence
• NanoBone® SBX Putty ; NanoBone® QD (K250521): indications, design and recorded evidenceRegulatory decision evidence
• NanoCeram Resin (K262681): indications, design and recorded evidenceRegulatory decision evidence
• NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) (K233708): indications, design and recorded evidenceRegulatory decision evidence

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