FDA 510(k) clearances — page 822
clearances on record, most recent first.
Clearances — page 822
82,101–82,200 of 176,637- K002530 — WELCH ALLYN SPOT CHECK DEVICE
- K003308 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1
- K001177 — PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
- K001440 — NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
- K001993 — SOF-TACT DIABETES MANAGEMENT SYSTEM; SOF-TACT GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS
- K002023 — MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
- K002059 — AMT SPINAL SYSTEM
- K002520 — ROVERS SPATULA
- K002521 — SPARTAN MTS
- K002552 — HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
- K002615 — SURGICAL SYSTEM WITH CRYOGUIDE
- K002677 — NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM
- K002680 — TISSUELINK MONOPOLAR FLOATING BALL'
- K003349 — ALLON 2001 MODIFIED
- K002062 — SAMSUNG 10DR IMPLANT SYSTEM
- K002357 — 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS
- K002475 — REPLACE TPS COATED IMPLANTS
- K002476 — LUMBOPERITONEAL SHUNT SYSTEM
- K002486 — PRECIMED TRAUMA SYSTEM
- K002503 — FETALGARD LITE
- K002687 — ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3
- K002693 — CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
- K002720 — FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO
- K002805 — KENDRO HERACELL CO2 INCUBATOR
- K003179 — SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
- K002139 — ETEST LINEZOLID
- K002459 — PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
- K002463 — STELLAR
- K002473 — WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
- K002499 — BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
- K002502 — CERAM-PRIME
- K002640 — FREEDOM AUTOMATIC FILM PROCESSOR
- K002707 — PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING
- K002792 — CARESIDE CHOLINESTERASE
- K002812 — IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
- K002966 — OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR
- K003167 — MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K003220 — PERSONAL ECG TRANSMITTER, MODEL CG-6550
- K003244 — MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K003256 — PCCR DIGITAL IMAGING DEVICE
- K003315 — SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
- K003331 — QWH-149 WRIST ARRAY COIL
- K003340 — OBC-149 BREAST ARRAY COIL
- K000870 — KM-10 TENS ELECTRODE
- K001433 — CNS-9300 SERIES CENTRAL STATION
- K003070 — ETHIBOND EXCEL VALVE LOOP SUTURE
- K003087 — MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
- K003133 — MULTIPLE-VINYL EXAM GLOVE, POWDERED
- K003181 — IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ
- K003193 — DUPLOGRIP
- K003204 — BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
- K003208 — R & D 3K RETIC
- K000023 — FRIENDLY LIGHT ER:YAG PULSED LASER
- K002904 — WILLI GELLER CREATION AND LF PORCELAIN
- K002990 — VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001
- K003235 — PE.R.I. II KNEE FRACTURE SYSTEM
- K003287 — MODEL K7 EVALUATION DEVICE
- K003296 — BIOMET SCK KNEE SYSTEM
- K992493 — VIPON TAMPON
- K001044 — ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
- K001213 — CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60
- K001347 — MERIDIAN-II AND MERDIAN-PLUS
- K001714 — MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
- K001788 — ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200
- K002398 — ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND ETS COMPACT-FLEX45 NO-KNIFE ARTICULATING
- K002421 — CANDELA MID IR DIODE LASER SYSTEM
- K002509 — NOVALIS (SHAPED BEAM SURGERY SYSTEM)
- K002582 — PILLING E-FRAZIER BIPOLAR SUCTION TUBE
- K002704 — KSEA MINIATURE NEUROENDOSCOPE
- K002924 — 3D ENDOSCOPE
- K003019 — PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
- K003217 — HERMES PORT EXPANDER
- K003222 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
- K003233 — RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE
- K003294 — BIOMET LATERAL TROCH PLATE
- K001249 — QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3
- K001455 — ACCUWELL TSH, MODEL KAW-TSH-960
- K001676 — OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A
- K002103 — SIMPLICITY SPINAL SYSTEM
- K002390 — QUANTUM INTERSEGMENTAL TRACTION TABLE 400, 401, 400H,401H
- K002392 — VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
- K002456 — MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
- K002662 — HARDYDISK CLINDAMYCIN, 2MCG
- K002872 — R&D PROJECT DW271#11A
- K003112 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
- K003131 — MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
- K003236 — RETINADX
- K001948 — CVPROFILOR D0-2020 CARDIOVASCULAR PROFILING SYSTEM
- K002362 — SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
- K002363 — MEDOVATIONS ESOPHAGEAL DILATOR
- K002374 — ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT
- K003052 — NUMED TYSHAK II AND Z-MED II PTV CATHETERS
- K003114 — NUMED TYSHAK AND Z-MED PTV CATHETERS
- K003282 — FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H
- K991783 — AB-180 XC SYSTEM, MODEL AB-180XC
- K002025 — RIGID GAS PERMEABLE CONTACT LENS
- K002361 — SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM
- K002546 — CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
- K002556 — CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
- K002590 — CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER
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