Cruxi research & evidence
Biocompatibility Testing (ISO 10993 Program) evidence guides — page 15
Compare documented facts, dated analyses and evidence that can change your project scope. Confirm applicability with a specialist.
Compare Biocompatibility Testing (ISO 10993 Program) providers- Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) (K223100): indications, design and recorded evidenceRegulatory decision evidence
- Hudson RCI Triflo II Incentive Deep Breathing Exerciser (K220565): indications, design and recorded evidenceRegulatory decision evidence
- Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) (K253322): indications, design and recorded evidenceRegulatory decision evidence
- Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe (K211555): indications, design and recorded evidenceRegulatory decision evidence
- Hystero-V Hysteroscope (K202445): indications, design and recorded evidenceRegulatory decision evidence
- ICS Dizcovery (1091) (K242198): indications, design and recorded evidenceRegulatory decision evidence
- IMPEDE-FX Embolization Plug (K182390): indications, design and recorded evidenceRegulatory decision evidence
- IMPELLA CONTROLLER (K093801): indications, design and recorded evidenceRegulatory decision evidence
- IMPULSE AND EXPO ANGIOGRAPHIC CATHETER (K120495): indications, design and recorded evidenceRegulatory decision evidence
- INFINITI Ambi Angiographic Catheter (K232573): indications, design and recorded evidenceRegulatory decision evidence
- INNI-CERA (K211308): indications, design and recorded evidenceRegulatory decision evidence
- INOUE BALLOON A (K220881): indications, design and recorded evidenceRegulatory decision evidence
- INTEGRATE -C Interbody Fusion System (K222004): indications, design and recorded evidenceRegulatory decision evidence
- IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 (K191435): indications, design and recorded evidenceRegulatory decision evidence
- IPL Hair Removal Device (JM-843, JM-865, JM-638) (K241881): indications, design and recorded evidenceRegulatory decision evidence
- IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) (K232499): indications, design and recorded evidenceRegulatory decision evidence
- IPL Treatment Device (MDSQMC-01) (K243123): indications, design and recorded evidenceRegulatory decision evidence
- IS-III active Short Implant (K232049): indications, design and recorded evidenceRegulatory decision evidence
- ISO 10993-1 Sixth edition 2025-11 — FDA recognition transition and report handoffCompliance research
- ISO 10993-17 Second edition 2023-09 — FDA recognition transition and report handoffCompliance research
- ISO 10993-4 Third edition 2017-04 [Including AMD1:2025] — FDA recognition transition and report handoffCompliance research
- ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System (K221872): indications, design and recorded evidenceRegulatory decision evidence
- Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) (K250194): indications, design and recorded evidenceRegulatory decision evidence
- Impella XR Sheath Set (K202330): indications, design and recorded evidenceRegulatory decision evidence
- Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (K151845): indications, design and recorded evidenceRegulatory decision evidence
Page 15 of 38