FDA 510(k) clearances — page 861
clearances on record, most recent first.
Clearances — page 861
86,001–86,100 of 176,637- K993038 — TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
- K990977 — SERAQUEST EB VAC IGM
- K991474 — HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NATURAL LATEX LAMINATED WITH NITRILE, EXTERNA
- K991914 — SUPER SOOTHER
- K992274 — MODIFICATION TO IMX HOMOCYSTEINE
- K992685 — QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C
- K992861 — SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K992922 — SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
- K992956 — LUCITONE FRS FLEXIBEL DENTAL RESIN
- K993004 — ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
- K993064 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
- K993100 — REDI-SCREEN
- K983793 — PREFERENCE TREATMENT SYSTEM
- K990324 — NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM
- K990723 — DYONICS VARICOSE VEIN ABLATION BLADE
- K992442 — V.T.S., INC. (V.T.-3)
- K992460 — CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY
- K992714 — MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010
- K992782 — NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES
- K992904 — MINI-PORT
- K992907 — INTRADUCER
- K993055 — DEXIDE BIPOLAR FORCEPS II** DEVICE
- K993057 — MBA
- K993083 — ALCYON 300I (WITH ISE MODULE) ANALYZER
- K993111 — ASCENT KNEE SYSTEM
- K991531 — CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
- K992127 — CARDIOQUANT TROPONIN I TEST
- K992262 — INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
- K992466 — OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR
- K993068 — VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK; VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
- K993132 — GENZYME DIRECT AMYLASE VERIFIER
- K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
- K990396 — T-ANASTAFLO
- K991965 — PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
- K992271 — PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
- K992272 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K992276 — MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
- K992292 — GLUMA COMFORT BOND + DESENSITIZER
- K992317 — AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION
- K992734 — BECTON DICKINSON SYRINGE
- K992775 — OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
- K992958 — ADVANTA GRAFT (<6MM)
- K992960 — ADVANTA GRAFT (>6MM)
- K993090 — SILHOUETTE FC
- K990992 — INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
- K984201 — DENZIR
- K984415 — S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F
- K991540 — WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
- K991947 — 3I CERAMIC ABUTMENT SYSTEM
- K992079 — KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
- K992141 — OLYMPUS WORKING ELEMENT FOR PROBES
- K992352 — ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
- K992378 — DIAGNOSTIC ULTRASOUND, MODEL 1.0
- K992622 — INTRAMAX ITI GUIDE CATHETER
- K992728 — SPRING POWERLITE 2000
- K992736 — WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
- K992968 — CARTO EP NAVIGATION SYSTEM
- K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
- K992385 — ORTHOPANTOMOGRAPH OP100D
- K992680 — ELECSYS PARATHYROID HORMONE TEST SYSTEM
- K992798 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
- K992800 — SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
- K992801 — SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
- K993188 — ENDOSTEPPER 1
- K991667 — BROADLINE OR TOWELS
- K992117 — PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER
- K992420 — MODIFICATION OF PASCO MIC AND MIC/ID PANELS
- K992558 — NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE
- K992810 — HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
- K984210 — SILVERLON WOUND PACKING STRIPS
- K990253 — SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
- K990662 — DISPOSABLE HEATING TUBING SET #7642HSES
- K990816 — AVCORE SYSTEM
- K990900 — MICROKERATOME, MODEL MK-2000
- K990931 — EZ-HBT HELICOBACTER BLOOD TEST
- K991090 — PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)
- K991378 — PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED
- K991381 — PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA
- K991620 — VISINE FOR CONTACTS
- K991633 — QUICKVUE INFLUENZA A/B TEST
- K991800 — HEMOCHEK URINE COLLECTION KIT
- K992175 — EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
- K992250 — CORE AUDIBLE TROCAR II
- K992432 — BACT/ALERT FN
- K992444 — MODIFICATION OF: CELL-DYN 1200 SYSTEM
- K992517 — BIOCHECK FERRITIN ELISA MODEL BC-1025
- K992526 — FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
- K992572 — NTERO RF SLEEVE
- K992594 — A-15 HEMODIALYZER
- K992671 — QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
- K992686 — DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
- K992687 — MILLENIUM MICROKERATOME, MODEL IMD-001
- K992860 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
- K992876 — VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
- K992882 — LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
- K992946 — RENEW RECEIVER
- K992972 — ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE ELECTROSURGERY WAND, MODELS H2000
- K992981 — ELECSYS ESTRADIOL CALSET II
- K992986 — SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER
- K992988 — PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.