FDA 510(k) clearances — page 984
clearances on record, most recent first.
Clearances — page 984
98,301–98,400 of 176,637- 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
- K963116 — UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY
- K951113 — CROSS-CHECKS
- K960861 — OMICRON MONITOR, DELTA MONITOR
- K960962 — INTERFERENCE SCREW
- K961374 — PHILIPS MULTIDIAGNOST 4
- K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
- K961764 — PR-3 ELISA TEST SYSTEM
- K961765 — MPO ELISA TEST SYSTEM
- K961829 — QUALITROL CRP CONTROL SET
- K962069 — MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES
- K962101 — ZWEYMUELLER SL FEMORAL HIP STEM
- K962186 — N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
- K962227 — PRO-FECT STERILE GAUZE SPONGES
- K962261 — IMPLANTECH WM NASAL-LABIAL IMPLANT
- K962353 — ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
- K962372 — UROTAC BONE ANCHOR INSERTER
- K962699 — RADWORKS MEDICAL IMAGING SOFTWARE
- K962808 — ILIZAROV EXTERNAL FIXATION SYSTEM
- K954575 — AXSYM TOXO IGG ANTIBODY ASSAY
- K955107 — SAFESTRIP
- K955546 — PATIENT MONITOR MODEL 405P
- K960437 — RADIAS PHENYLALANINE TEST
- K960790 — PROSPORE II
- K961281 — TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60
- K961357 — PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE
- K961837 — RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
- K961896 — MICROLAB 4000, MICROLAB 4200
- K961976 — THE BIOPLATE FIXATION SYSTEM
- K962150 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K962280 — ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
- K962762 — SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
- K962809 — SEIRIN ACUPUNCTURE NEEDLES
- K963002 — ACTIVE ANDROSTENEDIONE EIA
- K951033 — ANDELA DYNAMIC COOLING DEVICE
- K954736 — ACCESS (POWERCLAVE)
- K954995 — QUIX RAPID CHOLERA STRIP TEST
- K955113 — DINAMAP SELECT MULTI-PARAMETER SYSTEM
- K955507 — GRAYCO POCKET PUMP
- K960584 — NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY
- K960841 — POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM
- K960940 — BIOSCREW ABSORBABLE INTERFERENCE SCREW
- K961365 — ENDOCARE ELECTORNIC THERMOMETER SYSTEM
- K961682 — ARGON CURING LASER
- K961912 — QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET
- K961915 — SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
- K961923 — BERENSTEIN COIL
- K961936 — MODEL 2188 CORONARY SINUS LEAD.
- K961973 — DHD ACE WITH MASK KIT
- K962023 — PLASTIC PROTECTION HEALING CAPS
- K962161 — BAXTER NEBULIZER CAP MODEL 2D0868
- K962215 — CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
- K962240 — MOORE TRACHEOSTOMY TUBE
- K962247 — HICHEM CK/NAC REAGENT KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.