FDA 510(k) clearances — page 528
clearances on record, most recent first.
Clearances — page 528
52,701–52,800 of 175,825- K082982 — BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES
- K083354 — FLORASEAL, MODEL FS350D
- K090599 — MD300K1 PULSE OXIMETER
- K090838 — STIMULUS/DISSECTION INSTRUMENTS
- K090972 — LEKSELL GAMMAPLAN
- K091384 — VINYL POWDERED EXAMINATION GLOVE
- K091444 — PERFSCAPE
- K091760 — DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)
- K091866 — PROGENY VANTAGE PANORAMIC X-RAY SYSTEM
- K091889 — DRX-EVOLUTION, MODEL VX3733-SYS
- K090587 — STARLIGHT
- K090734 — EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES
- K090941 — ADHESE ONE F
- K091024 — CHROMID MRSA AGAR, MODEL: REF 43 841
- K091296 — POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
- K091536 — OPTIMA MR450W
- K091558 — BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM
- K091617 — QMS LIDOCAINE CALIBRATORS, MODEL 0374678
- K091804 — CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS
- K092013 — SYNGO VOLUME PERFUSION-CT BODY
- K082849 — SILENT SLEEP
- K083183 — AKLARUS PHOTOTHERAPY SYSTEM
- K083419 — ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020
- K090825 — SQ IS SYSTEM
- K090914 — AXXENT BALLOON APPLICATOR, MODEL AB2034, AB2045, AB2056, AB2057E, AB2067E
- K090955 — SMITH & NEPHEW RF CANNULATE
- K091179 — MONACO RTP SYSTEM, VMAT OPTION
- K091900 — ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE
- K092088 — VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713
- K083903 — 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
- K083912 — TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS
- K090285 — SONICAID FM820 AND FM830 ENCORE
- K090707 — TALOS INTERVERTEBRAL BODY FUSION DEVICE
- K090893 — TIGRT TPS
- K091008 — STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55
- K091021 — MODIFICATION TO MEDICOMPASS CONNECT
- K091156 — TRIMED STERILE PRODUCT
- K091442 — CD HORIZON SPINAL SYSTEM
- K091666 — PASCAL PHOTOCOAGULATOR, PASCAL-US
- K091834 — PASSPORT V MONITOR, MODEL 0998-00-6100
- K083704 — NUTRAC PELVATOR, MODEL PEL 200
- K090389 — AP-1000 BLOOD GLUCOSE MONITORING SYSTEM
- K090527 — SINUS QUICK IT SYSTEM
- K090655 — PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260
- K090857 — VALOR ANKLE FUSION NAIL SYSTEM
- K090952 — ZYFUSE FACET FIXATION SYSTEM
- K091067 — 5.5 POLARIS SPINAL SYSTEM
- K091088 — LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
- K091180 — MINITAPE URETHRAL SLING
- K091274 — CORONIS 5MP HD, MODEL MDMG 5121
- K091517 — RALCO, MODEL R225 ACS
- K091751 — DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
- K091922 — WATERLASE C100, MODEL 7100104
- K090188 — U-RIGHT TD-4227 NO CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4222
- K091153 — SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291
- K091479 — APTUS FOOT SYSTEM
- K083154 — NEWDEAL HALLU LOCK PLATE SYSTEM
- K083712 — WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
- K090688 — COOK UROLOGICAL GRAFT
- K090988 — GMK TOTAL KNEE SYSTEM
- K091159 — SYNTHES ORACLE PLATE
- K091689 — SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
- K091908 — M3 MONITOR
- K081998 — H-WAVE SPORT
- K082871 — XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
- K083130 — NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
- K083812 — REFRESH OPTIVE LENS COMFORT REWETTING DROPS
- K090165 — RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
- K091044 — SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM
- K091057 — MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
- K091109 — XPERT C. DIFFICILE
- K091219 — DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
- K091224 — OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-S
- K091308 — ALARIS PC UNIT, MODELS 8000 AND 8015
- K091470 — RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
- K091474 — EASY.TOUCH INSULIN SYRINGE
- K091515 — SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM
- K091523 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K091700 — AIRCAST VENAFLOW ELITE SYSTEM
- K091793 — AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54
- K091909 — LITHO LASER SYSTEM
- K091941 — DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
- K082620 — ONCE-A-DAY VERTOS TEST PACK
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.