FDA 510(k) clearances — page 976
clearances on record, most recent first.
Clearances — page 976
97,501–97,600 of 175,890- K962581 — STOPCOCK MANIFOLD GANGS
- K962801 — SAFE MATE I.V. EXTENSION SETS
- K962802 — SAFE MATE I.V. FLUID DELIVERY SETS
- K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
- K955880 — DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05
- K960205 — CPR TRACHEOTOMY CARE TRAY
- K960356 — POSTERIOR ANNULOPLASTY BAND (MODEL 607)
- K960435 — PHOENIX CRX VALVE
- K961587 — IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25
- K961718 — DEI MODEL 20 EEG
- K962099 — CEDIA PROCAINAMIDE ASSAY
- K962117 — QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
- K962154 — CARBOMEDICS HANDLE
- K962396 — KSEA BIPOLAR GOAGULATING FORCEPS
- K962397 — STATAK SOFT TISSUE ATTACHMENT DEVICE
- K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
- K962898 — KSEA UNIMAT PLUS
- K962934 — AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR
- K963163 — ELECSYS CALCHECK FT3
- K963164 — ELECSYS CALCHECK FT4
- K963167 — ELECYS CALCHECK T 3
- K963178 — ELECSYS CALCHECK T4
- K960424 — BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
- K960767 — LIGHT COMMANDER
- K961250 — DYNATRON 125 ULTRASOUND
- K962085 — SALTER LABS 8990 SERIES NEBULIZER
- K962121 — HORIZON/WESTHIN 55-G
- K962279 — ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES
- K962940 — RAVEN EYE, INC.- EYE WEAR
- K963083 — LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES
- K963284 — RAVEN EYE- EYE WEAR (SUNGLASSES)
- K954576 — AXSYM TOXO IGM
- K954594 — RETICULOCYTE METHOD, RBC INDICES
- K960826 — CADD-PRIZM MODEL 6100 PUMP
- K961083 — OREX SURGEON'S VEST
- K961103 — BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT
- K961263 — MODEL 1200 ABMULATORY INFUSION PUMP
- K961311 — HEMOCUE B-GLUCOSE SYSTEM
- K961699 — EQUIPMENT COVERS
- K961721 — STERITEC DISPOSABLE BIOLOGICAL TEST PACK
- K962051 — ASPECT OPTICAM
- K962076 — MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6)
- K962080 — RPS-50 BEAM SCANNER
- K962094 — MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
- K962095 — MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES
- K962131 — STORZ D4600 AIR EXCHANGE LINE PACK
- K962196 — NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS
- K962779 — COMPRESSION SCREW
- K962866 — OPUS HLH
- K962875 — ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
- K962906 — SCRIPPS LABORATORIES HCG ONE-STEP
- K962916 — HUA-XIA ACUPUNCTURE NEEDLES
- K962982 — NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
- K963005 — NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
- K963059 — SUNQUEST INTERNATIONAL
- K963143 — ELECSYS CALCHECK TROPONIN T
- K963147 — ELECSYS CALCHECK TSH
- K963182 — ELECSYS CALCHECK CK-MB
- K963194 — ITO ACUPUNCTURE NEEDLES
- K951052 — WEEKS APPLICATOR
- K960903 — KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY
- K961122 — STRYKER KNIFELIGHT
- K961692 — SONOSCAN
- K961768 — KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
- K961843 — GENIE
- K961861 — VARIOUS DENTAL IMPLANTS WITH COVER SCREWS
- K962013 — MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
- K962036 — MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD
- K962103 — BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
- K962114 — ARTHRO-SURGIMAT
- K962155 — GILL-THOMAS-COSMAN(GTC) DENTAL TRAY
- K962241 — GORE SPHEREX IMPLANT
- K962665 — A-DEC SELF-CONTAINED WATER SYSTEM
- K962912 — MARCELLA CARAN
- K963075 — FITO DIDO
- K954920 — MUREX RUB-EX
- K954932 — BBL MGIT PRODUCTS
- K960321 — CARDIOCATH CATHETERIZATION LAB SYSTEM
- K960636 — LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER
- K961416 — DIALYSIS MIXING & HOLDING TANK
- K961792 — BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY CONTROLS
- K961849 — THE ROBOGUIDE
- K962012 — ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
- K962072 — PRONEB TURBO COMPRESSOR MODEL 38V0200
- K962174 — BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)
- K962294 — IMMAGE IMMUNOCHEMISTRY SYSTEM
- K962750 — 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR
- K962974 — SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713)
- K951853 — ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC)
- K953955 — POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
- K953956 — BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
- K953958 — POWDERFREE BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
- K954690 — STRYKER ORAL MAX SYSTEM
- K961207 — EP-X BIPLANE
- K962369 — TALKING DIGITAL THERMOMETER
- K962386 — SENSOR SHEATH TS1
- K962485 — OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)
- K962838 — PERMARIDGE SYRINGE
- K962901 — OLYMPUS B5-2C/B7-2C BALLOON CATHETER
- K963085 — LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III
Data sourced from openFDA. This site is unofficial and independent of the FDA.