FDA 510(k) clearances — page 665
clearances on record, most recent first.
Clearances — page 665
66,401–66,500 of 175,825- K043308 — MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
- K043374 — DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING
- K043387 — VASCON POLARIS GUIDING CATHETER
- K043421 — OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
- K043431 — GAMMA3 NAIL SYSTEM
- K043496 — SPACELINE EMCIA, MODEL CU580
- K043498 — TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE
- K050103 — XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
- K050104 — APEX MEDICAL MININEB & MINIPLUS
- K050118 — EBI TROCHANTERIC NAIL SYSTEM
- K050189 — TECHTONIX SYSTEM
- K050230 — TURBO TEMP TRIO
- K040958 — PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
- K041839 — 8NONE
- K042735 — N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
- K042884 — DAKOCYTOMATION ER/PR PHARMDX KIT
- K043139 — USCOM 1A
- K043147 — ACHIEVA FAMILY
- K043266 — RANDOX URINE CONTROLS
- K043268 — SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
- K043370 — PLANET 50 MONITORING SYSTEM
- K043438 — LARGE BORE SPLITTABLE INTRODUCER KIT
- K043476 — STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT
- K050077 — SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
- K050132 — NEURO II-S
- K050218 — WAVELIGHT SINON
- K050240 — MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM
- K033862 — BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
- K042659 — MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
- K042730 — CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G
- K043222 — VISCUCAM C DIGITAL CAMERA
- K043589 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
- K050203 — ALLUX
- K041690 — MONARCH NASAL IMPLANT
- K041940 — HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS
- K042571 — STRYKER SPINE AVS TL PEEK SPACER
- K042757 — VANGUARD SSK KNEE SYSTEM
- K042834 — MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR
- K042992 — CORAIL AMT HIP PROSTHESIS
- K043006 — MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605
- K043094 — EASYSPINE SYSTEM
- K043282 — DEVILBISS AUTOADJUST, MODEL 9054 SERIES
- K043289 — E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
- K043325 — ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
- K043407 — INF 4160, MODEL D-FJ27F
- K043435 — QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR
- K043463 — ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS
- K043506 — ACUPUNCTURE NEEDLES
- K043523 — INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
- K050010 — WU'S POWERED WHEELCHAIR, MAMBO 36X
- K050011 — WU'S POWERED WHEELCHAIR, MAMBO F 120
- K050033 — LUCION
- K050073 — MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
- K050107 — HARVARD 2 SYRINGE PUMP, MODEL 2001-001
- K050109 — TRILLIUM BIOPUMP PLUS, MODEL BPX80T
- K050141 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS
- K050180 — EXPA-SYL
- K050226 — ASIAN INTRAMEDULLARY HIP SCREW NAILS
- K050264 — STEALTH PRODUCTS SEATING SYSTEM
- K033716 — TRIDENT ACETABULAR SYSTEM
- K040780 — ELECTROSURGICAL PENCILS
- K042513 — VECTORVISION OSTEOTOMY
- K042755 — MONOCHROME LCD MONITOR, RADIFORCE G51
- K043123 — APEX MODULAR HA HIP STEM
- K043254 — PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
- K043267 — POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
- K043420 — OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE
- K043434 — OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
- K050016 — HEMOCHRON SIGNATURE ELITE
- K050057 — COULTER LH 750 HEMATOLOGY ANALYZER
- K050062 — GEMIFLOXACIN, 5UG BBL SENSI-DISC
- K050079 — CD HORIZON SPINAL SYSTEM
- K050220 — EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
- K041390 — DIAMOND MEDISTIM
- K042343 — SCORPIO NRG KNEE SYSTEM
- K043122 — SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY
- K043188 — ALCOHAWK PRECISION
- K043189 — SONALIS, MODEL 2000
- K043251 — CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
- K043334 — BONE SOURCE HAC RAPID SETTING CEMENT
- K043414 — HL 188 & HL 189 BODY FAT METER
- K043459 — HEMOSIL FACTOR XII DEFICIENT PLASMA
- K043505 — DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
- K043525 — CATHETER INTRODUCER
- K043612 — ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D
- K043615 — OXYTEC, MODEL 900
- K050013 — RETRACTOFOAM
- K050063 — PROSTATE-63 CANCER DIAGNOSTIC TEST
- K050068 — LNOPV AD-L AND PD-L OXIMETRY SENSORS
- K050151 — MULTIDIAGNOST ELEVA
- K050202 — CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K040788 — CALM PATTERNS, VERSION 01.00.00
- K042807 — ADVIA IMS VALPROIC ACID METHOD
- K042808 — ADVIA IMS CARBAMAZEPINE METHOD
- K042854 — STEREOTAXIS ENDOVASCULAR GUIDE WIRE
- K043179 — SELECT 3D ARTERIAL CANNULA
- K043277 — C&G ACUPUNCTURE NEEDLE
- K043584 — LIQUICHEK BNP CONTROL
- K050088 — QUANTIX/OR BLOOD FLOW MONITOR; FLEXIBLE PROBE WITH OPTIONAL VESSEL STABILIZER
- K050113 — TINA-QUANT IGG GEN.2
Data sourced from openFDA. This site is unofficial and independent of the FDA.