FDA 510(k) clearances — page 791
clearances on record, most recent first.
Clearances — page 791
79,001–79,100 of 175,825- K012026 — TRIDENT ALL POLY CUP
- K003966 — WUNDCATH CONDUCTION CATHETER
- K011112 — CYCLOSPORINE CALIBRATOR
- K011256 — TORIC LITE LENS
- K011264 — MESH URETERAL STENT
- K011456 — DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
- K011499 — VISUALINE AMPHETAMINE DIPSTRIP ASSAY
- K011581 — AMERITEK BRACHYTHERAPY TEMPLATE
- K011596 — UREA NITROGEN (BUN) LIQUID REAGENT
- K011712 — LATEX EXAMINATION GLOVES- POWDER FREE, BLUE
- K011853 — ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
- K011883 — POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K011884 — POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
- K011982 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
- K010008 — AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
- K011076 — LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
- K011189 — VIADUCT MICROENDOSCOPE AND ACCESSORIES
- K011402 — BIOPSY SITE MARKER
- K011419 — CAVEX COLORCHANGE
- K011525 — SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)
- K011626 — CONCORD 72
- K011628 — CONCORD 82
- K011885 — SYNTHETIC POWDER FREE VINYL PATIENT EXAMINATION GLOVES
- K011955 — MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
- K011976 — OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
- K004043 — METAL TRANSCEND ARTICULATION SYSTEM
- K010051 — POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
- K010600 — SUPREMA POWERED WHEELCHAIR
- K011078 — MALLEABLE SHAFT CLAMP
- K011257 — ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM)
- K011401 — RAMBLER
- K011429 — MODEL 100 ACTIVITY MONITOR
- K011515 — MEDLINE GROUNDING PAD
- K011779 — AVIDCARE SERIES 100 TELEMANAGEMENT SYSTEM
- K011837 — LIFECARD CF 7 DAY
- K011847 — ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
- K011910 — IN-FAST BONE SCREW SYSTEM
- K011942 — AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
- K011948 — HOFFMAN II HYBRID RING CLAMP
- K011965 — IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
- K011993 — QUANTUM BLAST
- K012006 — MEDICAL DEPOT POWER NEB 1
- K012013 — LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
- K000265 — PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION
- K000266 — PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
- K003045 — HA-TI (HAND TITANIUM SCREW) IMPLANT
- K003779 — IMMOBILIZATION SYSTEM FOR ENT
- K003954 — STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
- K011155 — INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S
- K011291 — TEMPORALSCANNER THERMOMETER, SENSORTOUCH
- K011395 — MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
- K011557 — PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
- K011560 — TRUBYTE DENTURE BASE RESIN SYSTEM
- K011606 — PURESPERM BUFFER
- K011786 — VACUETTE SAFETY BLOOD COLLECTION SET
- K011862 — DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
- K011867 — LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600; LEVEL 2 #981700; LEVEL 3 #981800
- K011925 — HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
- K012017 — VARISEED 7.0
- K012072 — VOXAR VC, MODEL 1.0
- K012097 — VORTEX
- K983024 — PROTON THERAPY SYSTEM
- K002207 — MACROPOREPX PEDIATRIC SYSTEM
- K003551 — VENOUS HARDSHELL CARDIOTOMY RESEVOIR, MODEL VHK 4201
- K003823 — SCS DT-02 TRANSVERSE CONNECTOR
- K011129 — SIGN IM NAIL
- K011173 — TELEPAX
- K011229 — DEVILBISS 9000 SERIES CPAP, MODEL 9001
- K011825 — RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE
- K011851 — MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K011987 — MODIFIED M-IV MAMMOGRAPHY SYSTEM
- K010546 — POWDER FREE LATEX EXAMINATION GLOVES
- K010748 — SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
- K011138 — OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
- K011205 — ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125
- K011254 — EAR THERMOMETER, MODELS ST613C AND ST613F
- K011293 — POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
- K011311 — UROLOGIC
- K011422 — SURGICAL DRAPES
- K011497 — CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
- K011517 — LUTE; CORE
- K011808 — ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)
- K011834 — BIS ENGINE
- K011882 — SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K011924 — POWDERED BLUE NITRILE EXAMINATION GLOVES
- K011997 — MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX, 1295-XX-XX
- K001962 — S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-
- K002099 — S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-
- K002838 — GASTRIC SUCTION AND DRAINAGE CATHETER
- K003254 — CORTEZ NEEDLE FREE IV CONNECTOR, MODEL MMD-001
- K003662 — SPINE WORKS COLLAR
- K003876 — US SENSOR #CG-930P; TOCO SENSOR CG-940P
- K004026 — BRAIDED GUIDING INTRODUCER
- K010235 — TEMPTELLER INFRARED EAR THERMOMETER, MODEL CT-30/ CT-30DX
- K010841 — ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE
- K010871 — TGL FLEX REAGENT CARTRIDGE
- K011085 — GUIDEWIRE INTRODUCER SAFETY NEEDLE
- K011092 — CANDELA SPTL-1E PULSED DYE LASER
- K011117 — MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS
- K011342 — COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
Data sourced from openFDA. This site is unofficial and independent of the FDA.