FDA 510(k) clearances — page 521
clearances on record, most recent first.
Clearances — page 521
52,001–52,100 of 175,825- K091709 — MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
- K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE
- K083552 — MAXMORESPINE TOM STICK
- K090190 — WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM
- K090563 — HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
- K090650 — SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
- K090653 — POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM
- K090705 — BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
- K090991 — COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO
- K091216 — CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797
- K091440 — LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L
- K091574 — SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES
- K091584 — MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
- K091623 — LAMINOPLASTY FIXATION SYSTEM
- K091758 — BD SPINAL NEEDLE 27G
- K091767 — 3 WAY SILICONE FOLEY BALLOON CATHETER
- K091787 — MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
- K091803 — SMARTTRACK SYSTEM
- K092049 — IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT
- K092103 — DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)
- K092105 — RADIANALYZER XPRESS
- K092109 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K092182 — VOYAGER COMPACT IMAGING SYSTEM
- K092212 — BUSSE SURGICAL DRAPES III
- K092225 — AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR
- K092297 — ELETONE CREAM
- K092432 — AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L)
- K092513 — RAINBOW BLOCK
- K092566 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)
- K092650 — HEARTWAY POWER MOBILITY SCOOTER, S12
- K092747 — PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
- K092757 — THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR
- K092770 — SIMPLYGO HANDS FREE BREAST PUMP
- K092806 — AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
- K092810 — EP-WORKMATE SYSTEM, VERSION 4.2
- K092939 — PATLOG 2.0
- K092948 — APLIO MX SSA-780A, VERSION 1.0
- K092962 — CAROTID COIL 5000004901
- K090051 — LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
- K090361 — REMOTE INFRARED THERMOMETER, MODEL RC002
- K091540 — MTD 4000
- K092014 — SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
- K092204 — PMD VIEWER
- K092253 — MODIFICATION TO FMRI HARDWARE SYSTEM
- K092431 — BODY COMPOSITION ANALYZER, MODEL: IOI 353
- K092509 — EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE
- K092575 — ENGAGE/ENGAGE TR
- K092763 — IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
- K092804 — MICROSELECTRON HDR V2, MODEL 105.999
- K092834 — HOFFMAN XPRESS LINE EXTENSION
- K092863 — MAXIFLO, TAPERFLO
- K092949 — IMAGEGRID RADIOLOGY VIEWER SYSTEM
- K090724 — OR-LIGHT
- K091613 — TAKE 1
- K091918 — ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
- K092085 — ISPIRA RESUSCITATION UNIT
- K092516 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K093018 — G-PROX ENDOSCOPIC GRASPER, MODEL 205333
- K090716 — BEGO SEMADOS S-LINE
- K091878 — OSSEOLINK DENTAL IMPLANT SYSTEM
- K091907 — NOBELPROCERA IMPLANT BRIDGE ZIRCONIA
- K092070 — INTERPLATE C
- K092112 — BTI DENTAL IMPLANT TINY 2.5-3.0
- K092197 — PHOTEX30 DIODE LASER SERIES: 980, 810, 940
- K092218 — FLEXICARE BREATHING FILTERS
- K092287 — NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
- K090841 — ADDPLUS
- K090568 — MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
- K090712 — EOCENE SYSTEM
- K090919 — KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE
- K091217 — DBX DEMINERALIZED BONE MATRIX PUTTY
- K091332 — AIA-PACK RBC FOLATE
- K091386 — MICROFUSE DUAL RATE INFUSER
- K091679 — LEFORTE SYSTEM BONE PLATE
- K091721 — CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
- K092016 — SUPER-FINE PEN NEEDLE
- K092026 — EASYCARE TX, TX LINK
- K092037 — LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM
- K092041 — STELLAR FIDUCIAL MARKER, MODEL GFMIA
- K092058 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
- K092082 — SYNERGY CANNULATED SCREW SYSTEM
- K092111 — ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
- K092471 — MODEL SENTINELLA 102
- K092676 — TSRH SPINAL SYSTEM
- K092729 — BAXANO NEURO CHECK DEVICE
- K083927 — WATERLASE MD
- K091789 — CARTO RMT EP NAVIGATION SYSTEM V8
- K091910 — PICCOLO MAGNESIUM TEST SYSTEM
- K092056 — OPTOMED SMARTSCOPE, MODEL M3-1 EY1
- K092195 — CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
- K092234 — DYNESYS TOP-LOADING SPINAL SYSTEM
- K092539 — SEAMFREE
- K092678 — EVISION DATA MANAGEMENT SOFTWARE
- K092711 — GUARDIAN II HEMOSTASIS VALVE
- K092867 — IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT
- K091093 — PARCUS PPEK CF INTERFERENCE SCREW
- K091094 — PARCUS V-LOX PEEK CF SUTURE ANCHOR, MODELS: 10253, 10254, 10263, 10264
- K091962 — POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
- K092003 — CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
- K092161 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868BF
Data sourced from openFDA. This site is unofficial and independent of the FDA.