FDA 510(k) clearances — page 1625
clearances on record, most recent first.
Clearances — page 1625
162,401–162,500 of 175,890- K813240 — EMIT-AAD THEOPHYLLINE ASSAY
- K813241 — EMIT-AAD THEOPHYLLINE CONTROL
- K813247 — KANESON/COMFORT PLUS MANUAL BREAST PUMP
- K813249 — HELP-MATE
- K813269 — TWO PIECE OSTOMY SYSTEM
- K812104 — SIEMENS-ELEMA PSA 376
- K812407 — L.O.N. REUSABLE MANIFOLDS & STOPCOCKS
- K812408 — L.O.N. DISPOSABLE CORONARY MANIFOLD
- K812473 — HEAD PROTECTOR
- K812764 — KOI BLUE FIELD ENTOPTOSCOPE
- K812896 — I.V.E. REFRACTION SYSTEM
- K812898 — PE-01 ELECTRONIC INFUSION PUMP
- K812920 — EVENT MASTER
- K812932 — ANERIOD GAUZE
- K812949 — RMI TRANSILLUMINATOR, MODEL 292
- K813008 — RESPOND II...NEUROMUSCULAR STIMULATOR
- K813015 — HELIOSEAL
- K813022 — FUKUDA DENSHI CARDIMAX FK-12
- K813023 — FUKUDA DENSHI CARDIMAX FK-11
- K813045 — AQUANOMICS, #SP36SF
- K813046 — AQUANOMICS, #HHU60
- K813047 — AQUANOMICS, MINI 60L
- K813048 — AQUANOMICS, #MP2SF
- K813049 — AQUANOMICS, #HHU100
- K813050 — AQUANOMICS, #MP4SF
- K813057 — VIBRO-COM COMMUNICATOR #8827
- K813137 — CORREC TORR TM
- K813150 — DIRECTIONAL BOOT
- K813151 — VITATRON INSERT
- K813152 — ELECTRODE TERMINAL CAP
- K813153 — TEST MAGNET
- K813154 — ADAPTING SLEEVE
- K813194 — AUTO-SYRINGE SUB-CUTEANEOUS SET
- K813226 — GEL FLOTATION MATTRESS
- K813242 — QUANTIMETRIC 2 TEST KIT
- K812132 — STERILE SUTURE REMOVAL KIT
- K812538 — ELITE
- K813237 — HEMASITE VASCULAR ACCESS SHUNT HM-1000
- K810139 — ELECTRODE, PACEMAKER, PERMANENT
- K810286 — PACEPATH IMPLANT. ENDOCARD. PACING LEAD
- K812767 — SNIFF AIR COMPRESSOR #SF-6
- K812787 — EIA RUBELLA
- K812792 — PFT SCREENER (SYSTEM 1100)
- K812833 — TOTAL PROTEIN REAGENT SET
- K812841 — TOTAL & DIRECT BILIRUBIN REAGENT SET
- K812953 — RADCLIFFE VENTILATOR MARK 5
- K813013 — GEL ELECTRODE
- K813034 — POLYSTAN HEART LUNG MACHINE SYS
- K813035 — POLYSTAN VERTICLUDE BLOOD PUMP
- K813100 — BIO-STIMULATOR, MODEL 400
- K813101 — CARDIOBEEPER MEMORY MONITOR
- K813123 — EPC FILTER
- K813131 — INTERFACE ARTERIAL BLOOD FILTER
- K813140 — VYGON EXTENSION TUBES & CONNECTORS
- K813141 — VYGON STOPCOCKS & RAMPS(MANIFOLDS)
- K813142 — LEADER-CATH
- K813143 — DESILET
- K813144 — INTRAFLON, INTRAFLUX, INTRAVALVE
- K813146 — SYVA ADVANCE TM FLUOROMETER
- K813175 — 20CC GLASS CONTROL SYRINGE
- K813192 — HDL-C EIKEN
- K813228 — CONNECTING TUBE
- K813263 — PATIENT UNDERPAD
- K812868 — FETAL PULSE DETECTORS, F50/F60
- K813017 — NECKTRAC
- K812248 — COOLEY 2 VASCULAR PROSTHESIS STRAIGHT
- K812390 — NEUROSPONGE PADDIE
- K812391 — NEUROSPONGES
- K812626 — ACA ANTITHROMBIN III PLASMINOGEN CALIB
- K812628 — ACA FIBRINOGEN CALIBRATOR
- K812791 — PORTABLE MEDICAL TABLE
- K812864 — SILASTIC VOICE PROSTHESIS
- K812879 — OHIO NON-REUSABLE TRACHEAL TUBE MURPHY
- K812880 — OHIO NON-REUSABLE TRACHEAL TUBE MAJILL
- K812885 — DULBECCO MINIMUM ESSENTIAL MED NO GLUTAM
- K812908 — ELECTRO-GONIOMETER
- K812913 — OMEGA II ANGIOGRAPHIC TABLE
- K812915 — MX 125
- K812929 — 3.5 MHZ BIOPSY TRANSDUCER
- K812963 — IBIS II
- K812966 — 400T ECT SOFTWARE
- K812979 — VITAMIN B12/FOLATE DUAL RADIOASSAY KITS
- K812982 — BLOM-SINGER VOICE PROSTHESIS
- K813005 — KODAK CINEFLUOROGRAPHIC FILM SO-274
- K813016 — ZEE TRACTION SPLINT
- K813032 — ZIKON 100 DIGITAL X-RAY SYSTEM
- K813051 — COMPTAR III
- K813067 — SPINAL WRENCH
- K813090 — COMPOSITE DENTAL RESTORATIVE MATERIAL
- K813091 — FISSURE SEALER & BONDING AGENT
- K813099 — BACK RIE
- K813102 — POLI-MAK II
- K813106 — PORT-OP
- K813148 — S/P VORTEX MIXER
- K813149 — S/P VORTEX MIXER JR.
- K813167 — ORTHO UNASSAYED CONTROL SERUM LEVEL II
- K813185 — SALICYLATE STAT-PAK
- K811114 — MODEL P-8 PROFESSIONAL
- K811101 — HYDROXYLAPATITE
- K811842 — IMAGER 2000 REAL TIME SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.