HIF
EVA15 insufflator
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 176
Adverse events under product code HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
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 HIF
1–100 of 176- K250388 — ENDOFLATOR +
- K242772 — AirSurgN Insufflator (10030/AirSurgN)
- K243527 — High Flow Insufflation Unit (UHI-4)
- K242536 — TauTona Pneumoperitoneum Assist Device (TPAD)
- K232464 — VereSee Optical Veres Needle System
- K232902 — EVA15 insufflator
- K233020 — TauTona Pneumoperitoneum Assist Device (TPAD)
- K232401 — Disposable Veress Needles
- K230239 — AirSeal iFS System; AirSeal dV Solution
- K231342 — Insufflator (OPTO-IFL1000)
- K231407 — StarFin
- K222812 — Insufflator
- K221995 — Gas Insufflator
- K222901 — EVA15 insufflator
- K212786 — LevaLap Laparoscopic Access Device
- K211104 — AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
- K202799 — EVA15
- K201361 — PNEUMOCLEAR
- K193520 — EVA 15 Insufflator
- K193339 — GTK Veress Needles
- K191780 — AP50/30 Insufflator with Insuflow Port
- K190303 — AirSeal
- K172835 — GRI-Alleset Veress Needle
- K172516 — SurgiQuest AIRSEAL iFS System
- K173545 — TEMED Gas Diffuser
- K170799 — AP 50/30 Insufflator with Insuflow Port
- K162582 — HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
- K171139 — LaparoLight Veress Needle
- K170784 — PNEUMOCLEAR
- K161554 — ENDOFLATOR 40, ENDOFLATOR 50
- K162648 — U-Blade Veress Needle
- K153367 — S698 Symbioz flow
- K153513 — Insufflator 50L FM134
- K150068 — Unimicro Veress Needle
- K143404 — SurgiQuest AirSeal iFS System
- K142700 — InsufflatOR Needle
- K140263 — INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT
- K132203 — PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA
- K132204 — INSUFLOW SYNERGY XL PORT
- K122180 — HIGH FLOW INSUFFLANTION UNIT
- K120151 — NEBULAE I
- K120640 — INSUFLOW SYNERGY PORT
- K121336 — MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
- K112975 — CARBONAID C02 DIFFUSER
- K110294 — HIGH FLOW INSUFFLATION UNIT UHI-4
- K111955 — MEDLINE PNEUMOPERITONEUM NEEDLE
- K112357 — VESSEL GUARDIAN
- K111441 — UNIMAX VERESS NEEDLE
- K103692 — SUGIQUEST AIRSEALOPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000
- K102136 — VESSEL GUARDIAN
- K101320 — VASOVAPOR
- K090652 — ALPHA DUO LAP INSUFFLATOR
- K091366 — INSUFLOW DEWHEART
- K090456 — INSUFLOW
- K080852 — KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
- K072753 — REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE AND ACCESSORIES
- K073452 — MODIFICATION TO: ARAGON SURGICAL LAPCAP
- K070783 — SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
- K070651 — ARAGON SURGICAL LAPCAP
- K063367 — 45L CORE INSUFFLATOR, MODEL F114
- K063546 — INSUFLOW DEVICE, MODEL 6198
- K061387 — VERESURE BELL
- K060723 — 40 L HIGH FLOW INSUFFLATOR F113
- K052125 — CARBONAID GAS DIFFUSER
- K041560 — FLO-ASSISTANT
- K033614 — MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
- K030837 — 40 L HIGH FLOW INSUFFLATOR F108
- K033991 — MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
- K031014 — HI-FLO THERME PNEU 45, WISAP #7083, 7083V
- K030469 — LAPAROSHIELD CONDITIONED INSUFFLATION SET
- K022052 — 40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
- K021247 — PNEUMOPERITONEUM INSUFFLATION NEEDLE
- K022318 — VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
- K014166 — UHI-3 HIGH FLOW INSUFFLATION UNIT
- K011510 — MULTI HI-FLO PNEU, WISAP #7080
- K010053 — HUMI-FLOW, MODEL 6-850-00/ 01/02
- K002328 — SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
- K000180 — TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
- K003703 — TAUT-INSUFFLATION NEEDLE
- K003792 — STRYKER HEATED INSUFFLATOR TUBE SET
- K001533 — SURGIFLATOR-40
- K993625 — INSUFFLATION NEEDLE- 120MM, MODEL 900-200
- K001068 — NBS CONNECTING TUBE SET
- K000027 — INSUFFLATION NEEDLE, MODEL R65-933
- K991906 — LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
- K990662 — DISPOSABLE HEATING TUBING SET #7642HSES
- K992381 — CO2 GAS WARMER II, MODEL 6-800-00
- K983326 — OMNIFLATOR 7640 MODEL 7-640-00
- K983925 — ENDOPATH ULTRA VERESS NEEDLE
- K972675 — CO2 GAS WARMING UNIT (6-800-00)
- K973447 — OMNIFLATOR 6630(6-630-00)
- K981334 — LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)
- K981859 — SURGIFLATOR-20 ECU
- K980134 — KSEA N2O ENDOFLATOR
- K970866 — FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
- K973432 — SURGIFLATOR-30
- K955477 — HI-TEC CO2 INSUFFLATOR TYPE 1300
- K963423 — KSEA CO2 ENDOFLATOR
- K962683 — SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
- K955393 — NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.