FDA 510(k) clearances — page 826
clearances on record, most recent first.
Clearances — page 826
82,501–82,600 of 175,890- K001069 — MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
- K001081 — BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810
- K001095 — OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
- K001101 — XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
- K001103 — WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
- K001146 — GENYX FLEXIBLE INJECTION NEEEDLE
- K001322 — PERFORMER 30 HPS
- K001611 — DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
- K001664 — COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120
- K001670 — AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
- K001671 — ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
- K001674 — POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
- K001682 — VSCORE WITH EKG SIGNAL GATING
- K001688 — DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
- K001722 — AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE
- K001776 — MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
- K001787 — QUART ARTERIAL FILTER, MODEL HBF 140
- K001801 — STEATHSTATION TREATMENT GUIDANCE PLATFORM
- K001834 — SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K001862 — SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
- K001888 — UNICORN MODEL SYS0630
- K994130 — RECTOSIGHT RS 300-04
- K001031 — URANUS, COMFORTOUCH LASER SYSTEM
- K001080 — SPINE SYSTEM EVOLUTION
- K001150 — ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE
- K001227 — ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT
- K001417 — ONTRAK TESTCUP 502, MODEL 3016641
- K001443 — SUGAR CHEX ONE
- K001705 — STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
- K992757 — CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER
- K993154 — LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM
- K993939 — NICOLET EME LEGEND TC22
- K001364 — BD DIRECTIGEN FLU A+B
- K001679 — VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
- K001700 — XPLAN 2.1
- K001846 — ELECSYS INSULIN CALCHECK
- K994419 — FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
- K000565 — MODIFICATION TO NC-STAT
- K000619 — SCANDINAVIAN IVF SCIENCES AB, G2.2
- K000683 — MODIFIED SINGLE AXLE TOTAL ELBOW
- K000707 — LEICA COLPOSCOPE
- K001151 — ELECTROSURGICAL ELECTRODE FAMILY
- K001157 — MONARCH II IOL DELIVERY SYSTEM
- K001180 — TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
- K001258 — BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
- K001305 — MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM
- K001382 — AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
- K001517 — SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
- K000992 — MACROPOREDX DISTRACTOR SYSTEM
- K001226 — SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
- K001344 — ADVIA IMS
- K001569 — INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
- K000278 — VIVANT MEDICAL BIOPSY MARKER SYSTEM
- K000351 — HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE
- K000827 — UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
- K000906 — KLINIDRAPE SURGICAL DRAPES
- K000990 — OPUS 10 DENTAL DIODE LASER
- K001078 — SULZER ORTHOPEDICS MS-30 FEMORAL STEM
- K001107 — FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
- K001142 — AUDIO TECHNOLOGIES S:R.1
- K001172 — POLYESTER NONABSORBABLE SURGICAL SUTURES URP
- K001173 — NYLON, NONABSORBABLE SURGICAL SUTURES USP
- K001184 — SILK, NONABSORBABLE, SURGICAL SUTURES, USP
- K001185 — POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
- K001223 — ACULUX, MODEL AX3001, AX3002
- K001274 — LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K001277 — TRIFLANGE ACETABULAR CUP SYSTEM
- K001299 — PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
- K001481 — PALCERAM 49
- K001482 — AURENORM 75 KF
- K001601 — DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES
- K001637 — DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR
- K001640 — BIOSOFT RESIN
- K001643 — VARIS 1.4G
- K001649 — STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234
- K001667 — RESOLVE SURGICAL O.R. TOWELS
- K001672 — POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
- K001686 — GALILEO VENTILATOR
- K993623 — GEMINI E
- K993663 — FIRST CHECK HOME DRUG TEST (THC)
- K994138 — FIRST CHECK HOME DRUG TEST PANEL 3
- K994139 — FIRST CHECK HOME DRUG TEST PANEL 2
- K994238 — IL TEST LIQUID ANTITHROMBIN
- K000959 — CRITERION 60 OR PM 60
- K000978 — ANATOMIC TOTAL KNEE PROSTHESIS
- K000994 — BIPAP DUET LX BI-LEVEL SYSTEM
- K001066 — CD HORIZON ECLIPSE
- K001088 — ULTRASIM CT SYSTEM
- K001215 — DBEST HCG 2 IU/ML TEST KIT
- K001439 — ORTHOCEPH OC100 D
- K990209 — NOVAC7
- K991038 — VASO PRESS DVT SYSTEM, MODELS VP500, VP501
- K994384 — CLICKER
- K994393 — AEQUALIS UNIVERSAL SHOULDER GLENOID
- K001064 — BEHRING COAGULATION TIMER ANALYZER (BCT)
- K001219 — MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM
- K001240 — SERAGARD INJECTION PATCH
- K001269 — DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
- K001479 — PALCERAM 53
- K001480 — AURECAST 40 B
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