FDA 510(k) clearances — page 493
clearances on record, most recent first.
Clearances — page 493
49,201–49,300 of 175,770- K102556 — VOLPARA, VERSION 1.3
- K102582 — ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE
- K102604 — I-LOGIC INREACH SYSTEM
- K102632 — ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
- K102728 — ARSTASIS ACCESS SYSTEM
- K092398 — HSV STRAW
- K093438 — PARADIGM INTERSPINOUS FUSION PLATE
- K093683 — ORTHOPANTOMOGRAPH OP300
- K100123 — ACUMED WRIST ARTHRODESIS PLATE SYSTEM
- K100933 — CONSENSUS CS2 PLUS ACETABULAR INSERT
- K101760 — ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES
- K102006 — CRYOMEGA
- K102089 — GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K102092 — PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES
- K102099 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K102277 — INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
- K093816 — DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600
- K093893 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K100356 — TDS PRECISION DENTAL BAR
- K100903 — ANTI-HAV
- K100991 — IMC SURGICAL DRAPE
- K101324 — GE ECHOPAC MODEL BT10
- K101365 — ELECSYS CA 19-9 CALCHECK 5
- K101586 — XTRA AUTOTRANSFUSION SYSTEM
- K101657 — RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40
- K101768 — MIE SCINTRON GAMMA CAMERA SYSTEMS
- K101809 — FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
- K101813 — IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
- K101856 — ELECSYS CEA CALCHECK 5
- K101874 — GE LOGIQ P6/P6 PRO
- K102069 — JOURNEY UNICONDYLAR TIBIAL BASEPLATES
- K102094 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K102150 — SYNGO DYNAMICS, VERSION 9.0
- K102256 — GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND
- K102596 — ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
- K092723 — AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM
- K100213 — LUMANOSITY CELEBRITY, MODEL 204
- K101084 — CASPIAN SPINAL SYSTEM
- K101598 — EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)
- K101828 — POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K101871 — TRUSIGNAL SPO2 FINGERTIP SENSOR
- K101998 — KAIYANG ALUMINUM WHEELCHAIR
- K101999 — KAIYANG STEEL WHEELCHAIR
- K102096 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K102160 — STRETCH VINYL EXAMINATION GLOVE POWDER FREE
- K102355 — ZIP'R MANTIS POWERED WHEELCHAIR
- K102358 — ZIP'R3/ ZIP'R3 XTRA SCOOTER
- K102361 — ZIP'R4/ ZIP'R4 XTRA SCOOTER
- K102362 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K102431 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K102477 — NO!NO! SKIN
- K102687 — MIRADA RT
- K091989 — PERFADEX AND PERFADEX WITH THAM
- K093837 — ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM
- K100042 — DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM
- K101148 — WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS
- K101223 — SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA
- K101347 — MAGNETOM AERA; MAGNETOM SKYRA
- K101528 — 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM
- K101606 — MICROMED PD-8K INSULATION DEFECT DETECTOR
- K101622 — ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
- K101831 — ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
- K101849 — BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT
- K101880 — TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
- K101992 — 3D SCANNER, MODEL 1230
- K102104 — GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
- K102216 — XIO RTP SYSTEM
- K102684 — XELIS DENTAL
- K093107 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K101200 — PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
- K101311 — EP NAVIGATOR R3
- K101337 — A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
- K101537 — AIM 200, MAJOR SURGICAL LIGHT
- K101772 — TSRH(R) SPINAL SYSTEM
- K102090 — SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
- K102156 — MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
- K102373 — CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
- K102438 — PRIMALOK FACET FIXATION SYSTEM
- K102468 — ZOLL PROPAQ MD
- K102492 — P200MAAF
- K102495 — M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
- K092977 — EBERLE SHAVER SYSTEM ACCESSORIES
- K093834 — CRIT-LINE ANEMIA MANAGEMENT SOFTWARE
- K100114 — FAT CONCENTRATION SYSTEM
- K100391 — DEPUY UNIVERSAL GRIPTION TF CONES
- K101524 — C2000 POWERED WHEELCHAIR
- K101611 — RELAY POWER WHEELCHAIR
- K101825 — CRYOBALLOON ABLATION SYSTEM
- K101869 — PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)
- K101958 — AMSINO I.V. ADMINISTRATION AND EXTENSION SETS
- K102265 — LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
- K091956 — HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712
- K093137 — K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
- K100112 — SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
- K100550 — POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
- K101477 — BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
- K101566 — VITEK 2 YEAST CASPOFUNGIN
- K101710 — LUXATEMP ULTRA /STAR
- K101994 — APEX KNEE MODULAR TIBIA SYSTEM
- K102036 — DOCTOR SURGERY DIODE LASERS FAMILY
Data sourced from openFDA. This site is unofficial and independent of the FDA.