FDA 510(k) clearances — page 1197
clearances on record, most recent first.
Clearances — page 1197
119,601–119,700 of 176,637- K915448 — CORTICAL BONE SCREW
- K915522 — FLO-GARD(R) 6201
- K915523 — FLO-GARD(R) 6301
- K920040 — INTRADUCER
- K912618 — LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY
- K912728 — ALTAIR
- K913693 — ENZYGNOST(R) ANTI-CMV/IGM
- K913941 — PSG(TM) 20 GUAGE DOPPLER NEEDLE
- K914259 — TOUCH TALKER
- K914305 — SYTEC DENTASCAN
- K914366 — MEDRAD PATHFINDER HR ROADMAPPING SYSTEM
- K914404 — ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT
- K914417 — MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE
- K914444 — XPR PRINTER REDUNDANCY
- K914531 — STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES
- K914747 — XENON CIRCUIT
- K914807 — APEX HELIX - A
- K914954 — SPECTACLE FRAMES+ SUNGLASSSES(NON PRESC.)
- K915189 — STERILETX POWDER FREE LATEX EXAMINATION GLOVES
- K915253 — IR-192 IMPLANT, MODIFICATION
- K915421 — GUIDEWIRE INTRODUCER SET
- K915450 — IN THE EAR HEARING AID
- K915496 — DESERET GUIDEWIRE INTRODUCER
- K915535 — FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM
- K915552 — INSTRUMENTARIUM MEGA4
- K915644 — CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS
- K915705 — ACID PHOSPHATASE REAGENT SET
- K915783 — S.A.A. EYE GLASS FRAMES
- K920311 — CANNABINOID EIA TEST
- K920418 — IL TEST CANNABINOID, 35282
- K920466 — EXTEND-EAR
- K920507 — EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY
- K920570 — PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED
- K912685 — MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
- K913790 — SENSORMEDICS OXYSHUTTLE II(TM)
- K914105 — CATHWRITER(TM)
- K914109 — PIKOS 01 & PIKOS E 01
- K914219 — AIRWAY THERMISTOR
- K914283 — THAYER EXPANSION CHAMBER METERED DOSE INHALER
- K915305 — OPTION U1 FOR THE DPS-PLUS SYSTEM
- K915707 — AMMONIA REAGENT SET
- K905809 — NMC CYCLER MACHINE
- K913407 — NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE
- K913974 — ACCESS IMPRESSION BARREL
- K914492 — GASTROINTESTINAL TUBE AND ACCESSORIES
- K914849 — EXCEL MODEL XLT-ONE ND:YAG LASER SYSTEM
- K915439 — NASOGASTRIC FEEDING TUBE KITS
- K915618 — PROVICOL
- K915619 — IONOFIL/LONOFIL MOLAR
- K915626 — EZ GOLD
- K912888 — URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL
- K914174 — STERILE DISPOSABLE WET SKIN SCRUB TRAY
- K914215 — SELECTACUT BIOPSY DEVICE
- K914244 — STERILE CUSTOM SURGICAL KITS
- K914580 — DRS-4 DIALYZER REPROCESSING SYSTEM
- K915354 — LATERALASE
- K915438 — FEEDING TUBE Y-PORT CONNECTOR
- K915457 — PHACO 20/20 SYSTEM I
- K915484 — URETHRALPRESSURE PROFILE CATHETER
- K915809 — VISITEC CANALICULAR STENT
- K911646 — NGM ESTP MODULE
- K912794 — ECONOMATE/PATRIOT
- K912879 — MODEL SLASE 210 HOLMIUM (THC:YAG) LASER SYSTEM
- K912966 — PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG
- K913290 — MULTILASE 2100 A
- K913504 — STORZ MICRO CUTTER 25 GAUGE PACK
- K913623 — SURGICAL ELECTRICAL PENCIL
- K913833 — VENTREX ALLERGEN DISC
- K914158 — URIC ACID REAGENT SET
- K914579 — SILVER FOAM WOUND DRESSING
- K915337 — CAPIOX LEVEL ALARM
- K915356 — OPACITRAC
- K915492 — RSP MEGA SAMPLE PROCESSOR
- K915553 — USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING
- K915851 — QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
- K920403 — XENON ARC ENDOSCOPE LIGHT SOURCE
- K915285 — SKYTRON INFINITY SERIES SURGICAL LIGHTS
- K915303 — FOIL BABY BUNTING
- K915315 — AAP BONE PLATE
- K913417 — ETEX DENTAL IMPLANT SYSTEM
- K913842 — CORDIS RIGHT-ANGLE CATHETER GUIDE
- K914310 — OPTICAL FRAMES & SUNGLASSES
- K914699 — URESIL FIXATION DEVICE
- K914948 — AM 300 AGC-O
- K914953 — IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
- K915168 — PROFLEX 5
- K915238 — TRAC-WRIGHT TRAC 10 CATHETER
- K915304 — ABBOTT SMART CAP
- K915309 — KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
- K915310 — KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
- K915443 — URODYNAMIC CATHETER
- K920136 — WATERS 717 AUTOSAMPLER
- K920521 — RIONET HEARING AID HB-23T
- K920522 — RIONET HEARING AID HB-23M
- K911184 — SCANLAN/TAHERI VALVULOTOME
- K912444 — MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
- K912778 — HP-HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
- K913696 — GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE
- K913744 — IL TEST(TM) AMLYLASE
- K914072 — CONTINUUM KNEE SYSTEM (CKS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.