FDA 510(k) clearances — page 850
clearances on record, most recent first.
Clearances — page 850
84,901–85,000 of 176,637- K993671 — CANDELA SCLERO LONG PULSE DYE LASER
- K993961 — RAPID DRUG SCREEN 3-PANEL TEST FOR COCAINE, MARIJUANA (THC) (CANNABINOIDS) AND OPIATES (3 PANEL TEST FOR CTO)
- K994263 — SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
- K994418 — VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
- K992286 — DERMAFREEZE
- K992403 — MRP-TITAN
- K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
- K993415 — GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1
- K993417 — GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC)
- K993418 — FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL
- K993629 — ABI VEST AIRWAY CLEARANCE SYSTEM
- K993768 — CITATION TMZF HA STEM
- K994331 — REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
- K000067 — ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
- K992436 — GOWN BACK, MODEL 13-403N; 13-404N; 13-405N
- K992634 — IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5
- K992675 — PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
- K993483 — ACON ONE STEP HOME PREGNANCY TEST STRIP
- K993582 — MODIFICATION TO LASER-SHIELD II
- K993587 — HP M2376A DEVICE LINK SYSTEM
- K993598 — MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205
- K993682 — MRI EQUIPMENT COVER
- K993736 — EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
- K993797 — EC-7701 FLUID WARMING CABINET
- K993824 — MSAS PROFESSIONAL
- K993827 — UFI GEL HARD
- K993864 — COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
- K993865 — GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
- K994005 — SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
- K994013 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
- K994019 — CAUTERY GRASPER/DISSECTOR
- K994066 — MTP DISPOSABLE TROCARS
- K994070 — REVELATION POROUS HIP STEM
- K994084 — SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
- K994114 — DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
- K994173 — STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL 1025A-230
- K994189 — OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
- K994258 — SENSI-PRO DISPOSABLE POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES
- K994273 — MODEL 1000 HOLMIUM LASER SYSTEM
- K000030 — SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM
- K991545 — WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
- K993869 — INTER-OS BONE GENERATOR
- K984083 — MULTIFUNCTION KEITO K5
- K990445 — LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR
- K991390 — 1.5 M PROPANEDIOL FREEZING MEDIUM, 1.5 PROPANEDIOL 0.1 SUCROSE FREEZING MEDIUM, 9% GLYCEROL, 0.2 M SUCROSE FREEZING MEDI
- K991861 — 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
- K991936 — 3.0 ML RESERVOIR, MODEL 103/193
- K992448 — V.A.C. PLUS
- K992563 — A-22 HEMODIALYZER
- K992564 — AF-180 HEMODIALYZER
- K992566 — AF-150 HEMODIALYZER
- K992573 — AF-220 HEMODIALYZER
- K992658 — OSOM ULTRA STREP A TEST, MODEL 147
- K992727 — THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM
- K992811 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
- K992901 — GYNECARE VERSAPOINT G-VAP ELECTRODE
- K993239 — STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
- K993574 — OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
- K993599 — DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
- K993614 — FAS ENDOLUMINAL BRUSH
- K993658 — RENAMEL SCULPT
- K993659 — RENAMEL PACK
- K993720 — CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
- K993802 — SHARPVIEW IMAGE ENHANCEMENT SYSTEM
- K993813 — LUMAGEM SCINTILLATION CAMERA
- K993847 — TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES
- K993849 — TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE
- K993870 — UNSCENTED INTERLABIAL MENSTRUAL PAD
- K993920 — ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17
- K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
- K993942 — LITESABER 2000
- K993984 — SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
- K994040 — PHASED ARRAY KNEE AND FOOT COIL
- K994071 — RHIGENE ANA ELISA TEST SYSTEM
- K994081 — SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
- K994095 — LATEX CONDOM
- K994132 — HARDYDISK IMIPENEM, 10MCG
- K994200 — ACCESS HYBRITECH PSA QC, MODEL 37209
- K994330 — ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
- K994333 — ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES
- K994427 — CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL
- K994437 — CYNOSURE PHOTOGENICA SPIR
- K983953 — MICROSTREP PLUS PANEL, VANCOMYCIN
- K984551 — INFRARED EAR THERMOMETER, MODEL KI-8120
- K991916 — VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K992007 — PHARMASEED, MODEL BT-103-1
- K992684 — FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
- K992749 — ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
- K992785 — IBC FLOGUARD, MODEL 6050
- K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
- K993238 — FORTOSS-CEMA
- K993519 — RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
- K993679 — MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
- K993924 — WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
- K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
- K994063 — HARDYDISK AZTREONAM, 30MCG
- K994067 — HARDY DISK AMPICILLIN/SULBACTAM
- K994073 — HEMOSITE TEST SYSTEM
- K994277 — ACCESS OSTASE QC
- K994316 — MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
Data sourced from openFDA. This site is unofficial and independent of the FDA.