FDA 510(k) clearances — page 524
clearances on record, most recent first.
Clearances — page 524
52,301–52,400 of 176,542- 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
- K090636 — TSO3 OZONE STERILIZER, MODEL 125L
- K091111 — RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
- K091578 — LIFT CHAIR, MODEL T3
- K091934 — IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300
- K092614 — X-SMART EASY
- K092639 — INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
- K092710 — PENTAX ED-3490TK, VIDEO DUODENOSCOPE
- K092771 — DYNA LOCKING IM NAIL
- K092829 — INSERTEASE
- K092958 — AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES
- K093247 — MEDSYNAPSE PACS SOFTWARE
- K093313 — SYNERGY
- K093375 — KS-CARE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50UG OR LESS)
- K093434 — VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM
- K073214 — DUOWEDGE SYNTHETIC BONE SUBSTITUTE
- K090405 — LIPIDPRO SYSTEM
- K092017 — PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD)
- K092634 — OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF
- K092903 — BORA UP 2080, BORA UP 2080 OP AND BORA UP 2080 MOUNTING
- K093057 — BIOMET VISION FOOTRING SYSTEM
- K093456 — JETSTREAM G3 SYSTEM
- K093531 — ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
- K091248 — MAXEMS, MODELS 1000 AND 2000
- K092090 — ERBELIFT HAND PUMP AND FLEXIBLE PROBE
- K092341 — LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION
- K092439 — CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF
- K092871 — TRILOGY MX
- K093146 — IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
- K093272 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K093277 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
- K091824 — ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
- K092160 — POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES
- K092959 — AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152
- K093134 — CERNER CAREAWARE IBUS
- K093359 — 1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133
- K093387 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902
- K090326 — RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS
- K090796 — MULTI-BITE HOT BIOPSY FORCEPS
- K092191 — EXILIS, MODEL 5000
- K092230 — MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01
- K092473 — EXPEDIUM SPINE SYSTEM
- K092567 — MODIFICATION TO UNIGRAFT
- K092693 — VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS
- K092732 — PROPENCIL ESU PENCIL
- K093348 — 3.0T 16 CHANNEL HEAD NECK SPINE COIL
- K093521 — GDXPRO
- K093564 — SVED WOUND TREATMENT SYSTEM
- K083123 — MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES
- K090584 — INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS
- K091003 — ZIMMER MMC CUP
- K091650 — AXS-590 SERIES
- K091965 — POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED
- K092104 — ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
- K092231 — GEBDI TRIBOS 501
- K092656 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
- K092685 — PNEUMOTHERML, MODEL: 5800
- K092761 — PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C
- K092773 — CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST
- K092999 — NBP CUFF
- K093100 — REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)
- K093309 — PRO-LINE CT (BASIC TRAY) MODEL MR28036101
- K093352 — HG III FIXTURE SYSTEM
- K093366 — NMI PICC II
- K093501 — ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION
- K083770 — COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM
- K090925 — MULTIPLE (APEX LOCATOR), MODEL RCM-7
- K092135 — MODIFICATION TO IVENT 101
- K092166 — S. AUREUS/CNS PNA FISH, MODEL KT005
- K092687 — VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
- K093499 — HAIRMAX LASERCOMB
- K083754 — MINI LAP ELECTROCAUTERY INSTRUMENTS
- K090195 — PALOMAR LUX1540 HANDPIECE
- K090780 — MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE
- K091053 — PROPARAFLU+ASSAY
- K091468 — IVD TECHNOLOGIES ACHRAB TEST KIT
- K091795 — MEDTRADE PRODUCTS CELOX TRAUMA GAUZE
- K091814 — FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE
- K091862 — NESSI SPACER
- K092050 — IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01
- K092153 — SKYLINE 55, MODEL VER 1
- K092178 — AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
- K092498 — LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
Data sourced from openFDA. This site is unofficial and independent of the FDA.