FDA 510(k) clearances — page 536
clearances on record, most recent first.
Clearances — page 536
53,501–53,600 of 176,542- K091189 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K091397 — ECSCOPE 200
- K091431 — POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
- K091681 — FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
- K091792 — REST ASSURED GENERATION II DENTAL PROTECTOR
- K091882 — AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM
- K083094 — STREAMER POLYMER GUIDEWIRE
- K083658 — PACS PLUS 5TH EDITION
- K090194 — POWDER- FREE NITRILE EXAMINATION GLOVES, BLACK COLOR
- K090479 — TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
- K090579 — SMARTSCREENER-PLUS2
- K090670 — MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER
- K090709 — CORTEX DENTAL IMPLANT SYSTEM
- K090779 — ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
- K090802 — TIGRT MLC, TIGRT DMLC
- K091687 — PACSMATE, MODEL MMD-4300C/MMD-4300CX
- K091694 — MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)
- K091783 — THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
- K090256 — POWER STANDING DANI
- K090434 — BECE PRESS
- K090735 — C.T.M. MOBILITY SCOOTER, HS-528
- K090792 — MITAKA UNIARM
- K090901 — ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8
- K091242 — BANTAM
- K091418 — C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION
- K091482 — HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4
- K091723 — FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5
- K091727 — MEDICAL TREATMENT CHAIR, T400, T500,T600
- K083004 — MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM
- K083686 — BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES
- K083896 — DESTINY MAX COAGULATION ANALYZER
- K090522 — OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM
- K090541 — ELECSYS PRECICONTROL UNIVERSAL
- K090554 — ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
- K090582 — CALCANEAL FRACTURE PLATE SYSTEM
- K090851 — DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)
- K090981 — MODIFICATION TO: NUVASIVE SPHERX SYSTEM
- K091007 — AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05
- K091304 — VORTEX CANNULA
- K091377 — BD FLU+ SYRINGE
- K091378 — MAMMOSITE II RADIATION THERAPY SYSTEM
- K091596 — EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST
- K091627 — SMITH & NEPHEW INSTRUMENT TRAYS
- K091683 — KOWA VX-10 A
- K091854 — BIS CLICK SENSOR/CABLE
- K081923 — ACTIPROTECT UF N95 RESPIRATOR, DOUBLE STRAP, FLAT FOLD
- K082629 — S12X WITH ESAX OPTION
- K083689 — INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM
- K090211 — INFLATABLE BONE TAMP
- K090221 — REACTION SYSTEM
- K090336 — SUNMAX ENTERPRISE SHANGHAI CO. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS
- K090523 — POLARIS SPINAL SYSTEM
- K090613 — CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2
- K090847 — PLATELIA TOXO IGM KIT MODEL 26211
- K090935 — MINIME PEDIATRIC MASK
- K090983 — APTUS 2.0/2.3 FOUR CORNER FUSION PLATE
- K091299 — SPECTRANETICS TURBO-TANDEM SYSTEM
- K091587 — MERCURY SPINAL SYSTEM
- K091670 — BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER
- K091747 — FLAATZ 500
- K091816 — ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
- K091855 — THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000
- K091858 — PINNACLE STAIR WAY LIFT
- K091881 — RPL/CPL VERTICAL PLATFORM LIFTS
- K082450 — IDR
- K083583 — XPRESSE INJECTION SYSTEM
- K090115 — RETINA CAMERA TRC-NW7SF MARK II
- K090268 — SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION
- K090548 — CONTRA-ANGLE HANDPIECE KOMET OS30
- K090565 — ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM
- K090596 — ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM
- K090807 — REGIONAL OXIMETER SYSTEM, MODEL 7600
- K090910 — HANSO ACUPUNCTURE NEEDLE
- K090923 — PARCUS GRAFT FIXATION SYSTEM
- K090984 — INERTIA PEDICLE SCREW SYSTEM
- K091391 — UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
- K091609 — NEWDEAL COMPRESSION PLATE
- K091641 — HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT)
- K080365 — MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
- K083640 — DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D
- K090126 — FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,
- K090560 — CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS
- K090884 — PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA.
- K090885 — NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
- K090980 — HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
- K091001 — MYRIAN 1.4
- K091136 — AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200
- K091262 — MR CARDIAC FUNCTION ANALYSIS
- K091325 — TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS
- K091362 — CERAMIC PEDATRIC PREFORMED CROWN
- K091598 — LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS
- K091658 — GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121
- K083119 — PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
- K083256 — ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
- K083435 — ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
- K083756 — GUARDIAN 150 ELECTRODE
- K090164 — CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER
- K090484 — ALICE PDX
- K090580 — THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES
- K090583 — ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
Data sourced from openFDA. This site is unofficial and independent of the FDA.