FDA 510(k) clearances — page 516
clearances on record, most recent first.
Clearances — page 516
51,501–51,600 of 175,825- K093164 — 3.25 SPLINE TWIST IMPLANT, HA COATED
- K093228 — SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
- K093346 — BD GENEOHM MRSA ACP ASSAY
- K093527 — ARIA RADIATION ONCOLOGY WITH MIRS
- K093583 — EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
- K093665 — ENDO SMARTCAP
- K090940 — SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
- K092663 — ELI 350 ELECTROCARDIOGRAPH
- K093498 — LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913
- K081092 — MODIFICATION TO MAMMAPRINT
- K082588 — GAMMALOC SYSTEM, MODEL 03-00001
- K083845 — XTAG CF60 KIT V2
- K091233 — SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
- K091331 — PIEZOTOME 2
- K091364 — DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
- K091711 — S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
- K092417 — INSIGHT ULTRASONIC INSERTS
- K092505 — BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
- K092647 — LENSX 550 LASER SYSTEM
- K092682 — GYRUS ACMI FLEXIBLE ENDOSCOPE STORAGE-STERILIZATION TRAYS
- K092943 — ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
- K092964 — COOLTOUCH VARIA ND:YAG LASER SYSTEM
- K093117 — DIGITAL LIGHTBOX
- K093642 — NEUTRASAL
- K093672 — AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION
- K093691 — ACCUMAX
- K090794 — OSTEOTAPE
- K092002 — AFGHAN EXTERNAL FIXATOR
- K092099 — NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4251, TD-4252, TD-4253 AND TD-4254
- K092125 — PRESIDIO PACS
- K092596 — EAGLE EYE PLATINUM DIGITAL IVUS CATHETER
- K092644 — TERUMO PRESSURE ISOLATOR
- K092744 — NEONATAL ECG ELECTRODE, M203KEN
- K092807 — HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103
- K093227 — SILVERSTREAM AND DERMASEPT
- K093285 — MODIFICATION TO LANX SPINAL FIXATION SYSTEM
- K093514 — DISCOVERY MODEL NM/CT 670
- K093525 — ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE
- K093714 — SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
- K091884 — ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003
- K091992 — EIDOSMED, MODEL EDG4.0
- K092914 — WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES
- K093332 — DELPHI INFUSION PUMP/ DELPHI ADMINISTRATION SET MODEL IV-01000/ MODEL IV-02XXXX (WHERE X IS ANY NUMBER BETWEEN 0-9)
- K093750 — ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA
- K082683 — SD CHECK GOLD
- K083371 — NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
- K083372 — ARROWBONE-A, ARROWBONE-B
- K090686 — SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS
- K091051 — BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM
- K091457 — NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
- K092032 — BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160
- K092966 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K093052 — CROSSCATH SUPPORT CATHTER
- K093312 — KIMBERLY-CLARK GASTROINTESTINAL ANCHOR SET WITH SAF-T-PEXY FASTENERS, ENTERNAL ACCESS DILATION SYSTEM
- K082965 — DS-A BLOOD GLUCOSE MONITORING SYSTEM
- K091198 — LIQUID FILLED RING TEETHER, MODEL 03807, LIQUID FILLED RING TEETHER, MODELS 1962005, 1962011, LIQUID FILLED TEETHING
- K091746 — WATERLASE MD, MODEL 7100102
- K091875 — E-PULSE
- K092534 — ALATUS VAGINAL BALLOON PACKING SYSTEM
- K092782 — INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
- K092793 — MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
- K092951 — STARLIGHT PRO AND SILIVERLIGHT DENTAL CURING LIGHTS
- K093051 — HYLATOPIC PLUS EMOLLIENT FOAM
- K093166 — WITTMANN PATCH
- K093522 — QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C
- K090628 — DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
- K090889 — EMSI GARMENT ELECTRODES
- K091302 — INTEGRA MOZAIK AND OS MOLDABLE MORSELS
- K091352 — SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
- K091507 — RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
- K091582 — GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
- K091672 — DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES
- K091838 — OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCK
- K092482 — TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500
- K092514 — UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES
- K092603 — COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
- K092620 — MD300C318 FINGERTIP PULSE OXIMETER
- K092936 — AMIGO ESCORT 7.5, MODEL 760001 PHS
- K092956 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K093165 — ARTHROCARE SYSTEM 15000 CONTROLLER, ARTHROWANDS
- K093171 — VIAMO SSA-640A VERSION 1.2
- K093199 — 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK
- K093233 — D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
- K093455 — CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
- K093458 — SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
- K093528 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963
- K093570 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
- K093600 — OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM
- K092598 — ZOLL E SERIES WITH SPCO/SPMET OPTION
- K092605 — XIA 4.5 SPINAL SYSTEM
- K092660 — SIROLASER ADVANCE
- K092727 — H100B PULSE OXIMETER
- K092749 — MAS AND MINI-TROL PTH CONTROL
- K092820 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K092840 — INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL
- K093372 — SILS PORT MODEL SILSPT15
- K093446 — VITA VMK MASTER
- K093591 — STIMPOD MODEL NMS-400 NERVE STIMULATOR
- K093639 — SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
- K090526 — MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.