FDA 510(k) clearances — page 416
clearances on record, most recent first.
Clearances — page 416
41,501–41,600 of 175,770- K121743 — EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN
- K122175 — MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
- K122272 — CARDIOMEM
- K122744 — PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER
- K122770 — BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
- K122850 — TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
- K123100 — INTESS LUMBAR CAGE
- K123139 — ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
- K123178 — STRYKER VENOM ELECTRODES AND CANNULAE
- K123272 — 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM
- K123338 — BARRICADE EMBOLIZATION COIL SYSTEM
- K123512 — BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM
- K123624 — OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
- K123964 — AXSOS 3 TI LOCKING PLATE SYSTEM
- K123984 — QUANTIEN MEASUREMENT SYSTEM
- K130176 — FIREBIRD SPINAL FIXATION SYSTEM
- K130336 — 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540
- K130483 — BOEHRINGER GASTRIC SIZING TUBE
- K130625 — 12MM AND 13MM TIBIAL NAILS
- K113823 — HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
- K121823 — CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC
- K122480 — INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST
- K122494 — POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT
- K123762 — DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF
- K123859 — TBD
- K123870 — XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM
- K124029 — MICROLINE FLEXIBLE LIGATING SHEARS
- K122362 — SMART-WELL INCUBATOR
- K122560 — VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
- K123118 — INSIGNIA DIGICAST
- K123743 — ULTRASAFE PLUS PASSIVE NEEDLE GUARD
- K123976 — NOBELCLINICIAN
- K130415 — HIGH METABOLITE QUALICHECK
- K130671 — VENACURE EVLT NEVERTOUCH PROCEDURE KIT
- K113871 — PRO-DENSE BONE GRAFT SUBSTITUTE
- K123665 — LIFELINES IEEG
- K123745 — SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL
- K124059 — AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)
- K130173 — SONOSITE MAXX SERIES ULTRASOUND SYSTEM
- K130396 — RAMPART O AND RAMPART P
- K130754 — ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
- K122584 — HEMOSIL READIPLAS TIN
- K123618 — AXERA 2 ACCESS SYSTEM
- K130164 — FIBERLASE ENDURE CO2 FIBER
- K120771 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
- K121247 — ALCO-SCREEN
- K121946 — AXIS-SHIELD ACVTIVE-B12
- K122037 — ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST
- K122253 — PROCARE MONITOR B20
- K122456 — MRII CRAINIAL DRILL
- K123013 — ENDOSCOPIC INTRODUCER
- K123303 — FEMORAL ACCESS VENOUS CANNULAE
- K123457 — BALANCED KNEE SYSTEM HIGH FLEX PS
- K123556 — MORTARA SURVEYOR PATIENT MONITOR
- K123587 — HEINE MINI 3000 LED OPHTHALMOSCOPE
- K123652 — SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
- K124004 — NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
- K130009 — VARIAX 2 COMPRESSION PLATING SYSTEM
- K130141 — S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
- K130276 — DIMENSION EXL WITH LM SYSTEM
- K130596 — CAIMAN SEAL AND CUT TECHNOLOGY
- K113727 — SHENZHEN MED-LINK PULSE OXIMETER PROBE
- K120354 — BETA-TCP GRANULES
- K121772 — ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
- K121894 — XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
- K121979 — PASS OCT SPINAL SYSTEM
- K121981 — ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
- K122060 — CLEVER TD-7001NEBULIZER
- K122098 — APPS-HEALTH01
- K122206 — GARAVENTA X3 INCLINED PLATFORM LIFT
- K122218 — ADVANCE TOTAL KNEE SYSTEM-PATELLA
- K123335 — SUNRAY FETAL MONITOR
- K123498 — BP652N (HEM-6300-Z)
- K123511 — S9 VPAP TX
- K130112 — CAPNO MODULE, 92517
- K130221 — HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM
- K130344 — DORNIER MEDILAS UROPULSE
- K130413 — PINPOINTE FOOTLASER
- K130609 — VEEDA 100% COTTON MENSTRUAL TAMPON
- K130619 — ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM
- K120782 — INTERVENTIONAL HEMOSTATIC BANDAGE
- K121655 — BD ALCOHOL SWAB
- K122160 — VANGUARD XP KNEE SYSTEM
- K122247 — LIDCORAPID V2 MONITOR
- K123403 — AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
- K123468 — DEMI ULTRA
- K123640 — TX1 TISSUE REMOVAL SYSTEM
- K123687 — OPTETRAK LOGIC POROUS FEMORAL COMPONENT
- K123805 — E-Z CHEK BLOOD LEAK TEST STRIPS
- K123832 — OIC DISTAL RADIUS PLATING SYSTEM, OIC PROXIMAL HUMERUS PLATING SYSTEM, OIC CLAVICLE PLATING SYSTEM, THE OIC SMALL FRAGME
- K123952 — CEREC BLOCS C IN
- K130206 — PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
- K130228 — SUITEHEART
- K130229 — PALM BLADDER SCANNER
- K130247 — PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
- K130252 — CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
- K130257 — CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
- K130393 — MIRADA RTX
- K130433 — INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
- K122220 — ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S
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