Product code NEZ— Gastroenterology, Urology
GIVEN DIAGNOSTIC SYSTEM
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 47
Adverse events under product code NEZ
product code NEZ- Death
- 11
- Injury
- 218
- Total
- 229
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NEZ
- K252617 — MiroCam® Capsule Endoscope System
- K252480 — CE Deliver (DLV)
- K242643 — CapsoCam Plus (SV-3) Capsule Endoscopy System
- K240276 — PillCam Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software
- K233229 — NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether
- K230991 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
- K221590 — NaviCam Small Bowel Capsule Endoscopy System
- K211684 — PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
- K192662 — CapsoCam Plus (SV-3) Capsule Endoscopy System
- K183192 — CapsoCam Plus (SV-3)
- K183053 — Olympus Small Intestinal Capsule Endoscope System
- K180732 — MiroCam Capsule Endoscope System
- K173459 — Olympus Small Intestinal Capsule Endoscope System
- K170438 — MiroCam Capsule Endoscope System
- K170210 — PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
- K170839 — RAPID Web
- K163495 — AdvanCE capsule endoscope delivery device
- K163069 — OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
- K161773 — CapsoCam Plus (SV-3) Capsule Endoscope System
- K151635 — CapsoCam (SV-1)
- K143663 — MiroCam Capsule Endoscope System
- K142680 — ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT
- K140284 — GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
- K134005 — MIROCAM CAPSULE ENDOSCOPE SYSTEM
- K140751 — MIROCAM CAPSULE ENDOSCOPE SYSTEM
- K123864 — GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
- K123428 — MIROCAM CAPSULE ENDOSCOPE SYSTEM
- K123421 — OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
- K111450 — MIROCAM CAPSULE ENDOSCOPE SYSTEM
- K103025 — GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
- K101250 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
- K103088 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
- K101200 — PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
- K090210 — MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
- K091405 — PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
- K063259 — OLYMPUS CAPSULE ENDOSCOPE SYSTEM
- K070475 — MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
- K062786 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K053639 — GIVEN DIAGNOSTIC SYSTEM
- K040494 — CAPSULE DELIVERY DEVICE, 160CM, MODEL 711143; CAPSULE DELIVERY DEVICE, 210CM, MODEL 711144
- K040248 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K032405 — GIVEN DIAGNOSTIC SYSTEM
- K031033 — GIVEN DIAGNOSTIC SYSTEM
- K022980 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K022362 — GIVEN DIAGNOSTICS SYSTEM
- K020341 — GIVEN DIAGNOSTIC SYSTEM
- DEN010002 — GIVEN DIAGNOSTIC IMAGING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.