GE Healthcare
GE Healthcare holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2026, with 89 FDA device recalls on record.
Clearances by GE Healthcare — page 2
101–168 of 168- K111582 — LOGIQ S8
- K110943 — LOGIQ E9
- K103129 — ENTROPY EASYFIT SENSOR
- K111445 — DISCOVERY NM 630
- K110875 — CENTRICITY PACS
- K110834 — AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
- K103649 — VOLUSON S6, VOLUSON S8
- K103335 — GEM OPTION FOR 1.5 MRI SYSTEMS
- K103458 — VIEWPOINT 6
- K101236 — VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM
- K101166 — 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
- K101874 — GE LOGIQ P6/P6 PRO
- K101878 — GE LOGIQ P5 MODEL H44662LD
- K092271 — GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
- K092004 — GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
- K091658 — GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121
- K082540 — GE ENTROPY SENSOR
- K081091 — PRECISION 500D R&F X-RAY SYSTEM
- K071889 — DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
- K081105 — GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
- K061907 — MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
- K062580 — GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
- K072976 — MODEL 250CX SERIES MATERNAL/FETAL MONITOR
- K072986 — INTEGRADWEB PACS SYSTEM
- K071175 — OHMEDA MEDICAL GIRAFFE OMNIBED
- K071020 — DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE
- K063324 — PET VCAR
- K070421 — DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02
- K062324 — MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN
- K061942 — TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237
- K062576 — DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES
- K061741 — MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
- K062393 — GE VANTAGE PET NEURO SOFTWARE
- K061918 — FOLEY CATHETERS WITH TEMPERATURE PROBE
- K061994 — WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE
- K061625 — AUTOBONE2
- K061587 — FULLCARD ANALYSIS
- K061370 — CARDIQ FUSION
- K061185 — DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE
- K053121 — TRAM MODULE
- K060779 — ADVANCE VESSEL ANALYSIS II
- K052839 — CT PERFUSION 4
- K051217 — DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P)
- K051400 — DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS
- K052975 — DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE
- K052976 — DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
- K052972 — DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3
- K052977 — DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES
- K052995 — ADVANTAGE WORKSTATION 4.3.
- K052880 — DATEX-OHMEDA S/5 INTERFACE MODULE E-INT
- K052756 — DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM
- K052855 — STARSPEED SERIES CT SCANNER SYSTEMS
- K052582 — DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
- K052755 — DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
- K051873 — DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES
- K052412 — INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
- K052345 — ADVANTAGE SIM MD
- K052167 — DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES
- K052145 — DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
- K051967 — REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
- K051883 — DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES.
- K051634 — DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION
- K051635 — DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
- K051092 — DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
- K050835 — DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
- K050837 — REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE
- K043262 — GE SIGNA EXCITE MR SURGICAL OPTION
- K041543 — GE DISCOVERY ST
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