FDA 510(k) clearances — page 441
clearances on record, most recent first.
Clearances — page 441
44,001–44,100 of 175,770- K121412 — PAX-FLEX3D, PHT-7000
- K121545 — BELLYBOARD, SBRT ACCESSORIES
- K121554 — Q-FLO CLOSED MALE LUER CONNECTOR
- K112090 — BAHADIR STERILIZATION TRAYS
- K112607 — SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ...
- K120646 — CAPSURE(R) PS SYSTEM
- K120808 — EXPORT XT CATHETER, EXPORT AP CATHETER
- K120841 — APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR
- K120871 — SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION
- K121381 — VIEWFLEX XTRA ICE CATHETER
- K121444 — FLAT PANEL DETECTOR
- K112627 — MILLENIUM ANTI-SNORING DEVICE
- K113363 — ANGIOJET SOLENT DISTA THROMBECTOMY SET
- K113785 — ADHERENT VISUAL STIMULATOR GOGGLES
- K120198 — LOCATOR OVERDENTURE IMPLANT SYSTEM
- K120220 — ADAPTAIN SOLUBLE IMPLANT MATERIAL
- K120552 — AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
- K120712 — FORA COMFORTSCAN EAR THERMOMETER
- K120731 — TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY
- K120852 — ZIRCONIA BLANKS (ZIRCOSTAR)
- K120987 — DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF
- K121064 — MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
- K121094 — MEDCOMP VASCU-PICC & MIDLINE CATHETERS
- K121128 — MULTIPURPOSE HANDLING MEDIUM
- K121131 — BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
- K121318 — PROSOFT
- K121480 — ARIATELE TELEMETRY TRANSMITTER (96281)
- K121507 — ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE)
- K112191 — HEALEX BIOSPONGE WOUND DRESSING
- K113388 — CITIEFFE-TITANIUM CANNULATED SCREW
- K113703 — BAUSCH + LOMB NESOFILCON A CONTACT LENS
- K113793 — HOMOCYSTEINE TEST
- K120054 — ULTIMA NEO
- K120303 — CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
- K120691 — BRAIN PORT
- K120759 — CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION
- K121387 — CENTRICITY PACS-IW
- K121515 — ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
- K112766 — SNORKEL
- K120370 — VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS
- K120435 — BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR
- K120471 — MACH BRACKETS BRIGHT BRACKETS
- K120676 — S-250 PROTON BEAM RADIATION THERAPY SYSTEM
- K120689 — SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
- K120775 — LIGHT FOR WRINKLES
- K121008 — TRILLIANT SURGICAL K-WIRES
- K121035 — FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
- K121413 — CROSSFIX II MEMISCAL REPAIR DEVICE
- K113597 — MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES
- K120661 — THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE
- K111798 — STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ...
- K112580 — COLLAGEN WOUND DRESSING
- K112900 — SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
- K112937 — MRSA/SA ELITE MGB
- K113438 — ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
- K113846 — BORRELIA BURGDORFERI IGM BLOT TEST
- K120346 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM
- K120542 — CARDINAL HEALTH DURABLUE STERILIZATION WRAP
- K120638 — VANTAGE TITAN
- K120672 — KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR
- K120679 — SYNAPSE 3D NODULE ANALYSIS
- K120763 — LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
- K120779 — STRUCTUR 3
- K121073 — POWERGLIDE MIDLINE CATHETER
- K121135 — THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
- K121345 — SR SUITE 1.0
- K121350 — VIRTUSO SYSTEM FOR IHC (DO-7)
- K110734 — NCI SPATULA
- K111382 — CELVER
- K120033 — ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
- K120441 — GETINGE 700HC-E SERIES STEAM STERILIZER
- K120620 — CLEAN AND BOOST
- K120944 — KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
- K121023 — SPECTRUM V.0
- K121307 — OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ
- K121322 — CLOSER TO NATURE
- K121466 — GUIDEMIA
- K111956 — KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
- K112621 — WIS1000
- K112859 — ERAPID NEBULIZER SYSTEM
- K113402 — SOLOHEALTH STATION
- K113739 — SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM
- K120084 — ENDOSCOPIC RETRIEVAL DEVICE
- K120170 — PROCARE PLUS VITRECTOMY SYSTEM
- K120271 — ARTISAN SPACE MAINTENANCE SYSTEM
- K120395 — NERIA MULTI SUBCUTANEOUS INFUSION SET
- K120412 — 3M SPOTON TEMPERATURE MONITORING SYSTEM
- K120543 — TANDEMHEART FEMORAL ARTERIAL CANNULA SET
- K120574 — HAMILTON-C1
- K120829 — STAINLESS STEEL SPINAL SYSTEM
- K120882 — SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
- K121283 — BD EMERALD SAF-T SINGLE USE, HYPODERMIC
- K121340 — SOMNODENT G2
- K110472 — SI-FIX SACROILIAC JOINT FUSION SYSTEM
- K111004 — HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER
- K113561 — TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
- K120360 — ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
- K121427 — UNIMED TEMPERATURE PROBE
- K110074 — HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM
- K111049 — MOBILE VERSA LIGHT
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