FDA 510(k) clearances — page 526
clearances on record, most recent first.
Clearances — page 526
52,501–52,600 of 175,825- K091193 — ACCELL EVO3C
- K091357 — MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
- K091521 — POWERED VINYL PATIENT EXAMINATION GLOVES
- K091699 — AMSURE HYDROPHILIC LATEX FOLEY CATHETER
- DEN080011 — SNAP WOUND CARE DEVICE
- K083053 — EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)
- K083087 — ECOCEL
- K083429 — I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT
- K083643 — VERIFY 275F GRAVITY INDICATORS
- K090002 — ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
- K090493 — SIGNAL
- K090586 — BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC)
- K090791 — DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%
- K091039 — KOWA, FM-600, MODEL LSS50
- K091041 — RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS
- K091098 — KOWAGENESIS-DF
- K091165 — HORIZON XVU
- K091324 — SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET
- K091381 — IBEX SPINAL SYSTEM
- K091385 — APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
- K091548 — AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A
- K091554 — PHARMAPAC PERSONAL LUBRICANT
- K091626 — CRYOPATCH SG PULMONARY HEMI-ARTERY; TRUNK; BRANCH
- K091633 — TEPHAFLEX SURGICAL FILM
- K091702 — CDB FLIP-SIDE-CLIP BRACKET
- K091773 — FUJINON STERILE OVERTUBES
- K091856 — CONMED ECG MONITORING ELECTRODES , MODEL 1700 ( INCLUDING 2500), 1750, 2700, 2710, 1800, SERIES
- K091995 — LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
- K092064 — SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12
- K092073 — MONOPOLY PEDICLE SCREW SYSTEM
- K092075 — CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
- K092136 — PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
- K092299 — TRAILBLAZER SUPPORT CATHETER
- K092343 — EN SNARE ENDOVASCULAR SNARE SYSTEM
- K083603 — I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL
- K090107 — MINI TIGHTROPE
- K090240 — MONTERIS MEDICAL UFO
- K090358 — ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
- K091167 — SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES
- K091289 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K091365 — VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K091460 — ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087
- K092079 — MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
- K092235 — BEYONDIMAGE WORKSTATION
- K082329 — VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE
- K090750 — RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581
- K091396 — CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM
- K091648 — NURSE'S ASSISTANT O.R. CONTROL SYSTEM ,1.8
- K092043 — BIPAP SYNCHRONY 2
- K092078 — OPTILOCK PERIARTICULAR PLATING
- K090777 — EZC MEDICAL, LLC INTUBAIDFLEX
- K091062 — MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730
- K092207 — RESTORELLE POLYPROPYLENE MESH
- K083097 — AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM
- K083302 — LIFECARE ELECTRODES
- K083707 — ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE
- K091129 — QUATTRO LT
- K091319 — REMSTAR AUTO A-FLEX
- K091333 — S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
- K091659 — BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
- K091768 — VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
- K091944 — MODIFICATION TO: DSS STABILIZATION SYSTEM
- K070385 — TI-TAMED SPINAL SYSTEM
- K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
- K083408 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
- K083410 — POWDER FREE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL CLAIM
- K083810 — PASS LP SPINAL SYSTEM
- K083913 — CHESSON LABS LIQUID BANDAGE
- K090949 — SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS
- K090967 — BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
- K091178 — MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN
- K091229 — GLUCOMANAGER DATA MANAGEMENT SOFTWARE
- K091491 — HERO VASCULAR ACCESS DEVICE
- K091494 — FLEXITIME FLOW
- K091500 — MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556
- K091796 — SOFTLASE PRO, ORTHOLASE AND HYGIENELASE
- K091993 — RAPID PROGRAMMER, VERSION 3.3.0
- K083131 — MEDOS HILITE RESERVOIR, MODEL: 4030
- K083334 — ELASTO-GEL MANUKA HONEY WOUND DRESSING
- K083719 — LNCS OXIMETRY SENSORS
- K083870 — EXSALT SD7 WOUND DRESSING
- K090203 — 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
- K090224 — FORTEX PEDICLE SCREW SYSTEM
- K090812 — THERAFORM STANDARD/SHEET
- K090844 — BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
- K090850 — ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
- K090867 — AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002
- K090918 — NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER
- K090954 — ATLAS WOUND MATRIX
- K091013 — SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
- K091190 — UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063
- K091236 — MANTRA COMBO, MODEL MECS 320
- K091380 — CORDCAP
- K091390 — HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2
- K091392 — TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK
- K091422 — NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
- K091563 — RECRUIT MICROCATHETER
- K091662 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K091693 — TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK
- K091719 — NEOSALUS LOTION
Data sourced from openFDA. This site is unofficial and independent of the FDA.