FDA 510(k) clearances — page 559
clearances on record, most recent first.
Clearances — page 559
55,801–55,900 of 175,825- K073720 — ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
- K080123 — APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
- K080450 — STRYKER POWER TOOL NAVIGATOR ATTACHMENT
- K080731 — PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
- K080744 — HG II FIXTURE SYSTEM
- K080878 — MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT)
- K081059 — AEQUALIS REVERSED SHOULDER PROSTHESIS
- K081140 — VISENSIA
- K081172 — COMPOSITE HITCH SUTURE ANCHOR
- K081328 — PATHWAY PV ATHERECTOMY SYSTEM
- K081446 — BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237
- K081700 — SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION
- K081707 — AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
- K081716 — ADVIA CENTAUR HAVM ASSAY
- K072741 — PRE-VA VAGINAL LUBRICANT
- K072977 — DIAZYME APOLIPOPROTEIN A-1 ASSAY
- K080445 — LION SE ONE STEP ORTHODONTIC ADHESIVE
- K080905 — QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
- K081098 — ENDOBUTTON CONTINUOUS LOOP (CL)
- K081841 — AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
- K081873 — EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE
- K072136 — ULTRASONIC NEBULISER MODEL 2010
- K073115 — ORTHOMESH
- K080633 — SCREWINDIRECT DENTAL IMPLANTS
- K080897 — VENTURI NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- K080914 — ULTRASHARP CONCENTRIC NEEDLES
- K080975 — FENCER 308 EXCIMER LASER SYSTEM
- K081078 — NT/IT SYSTEM
- K081099 — TEPHAFLEX ABSORBABLE SUTURE
- K081366 — KUMAR T-ANCHORS HERNIA SET
- K081389 — ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
- K081437 — MAC 1600 ECG ANALYSIS SYSTEM
- K081843 — ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
- K081905 — ACCUFLOW AND ACCUFLUX ELASTOMERIC INFUSION PUMP
- K072143 — S40 CLINICAL ANALYZER, S TEST ALB
- K072291 — CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR
- K080982 — STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS
- K081089 — KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
- K081108 — MONOPOLY PEDICLE SCREW SYSTEM
- K081132 — SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
- K081188 — TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE
- K081234 — GN OTOMETRICS INSERT EARPHONES
- K081418 — SPINAL ELEMENTS BUTTRESS PLATE SYSTEM
- K081690 — SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
- K071677 — SRT II MUSCLE STIMULATOR
- K071810 — INION SPINAL GRAFT CONTAINMENT SYSTEM
- K073555 — INSULIN PROTECTOR
- K073581 — ICI P AND S SERIES IR CAMERAS
- K080047 — CARDIOSEN'C
- K080122 — SOPRO 670 ARTHROSCOPIC PUMP
- K080666 — HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS
- K081370 — SERIM DISINTEK OPA TEST STRIP
- K081802 — CX50 DIAGNOSTIC ULTRASOUND SYSTEM
- K081829 — CAPIMAGE
- K081882 — MODIFICATION TO XYLOS SURGICAL MESH
- K073074 — KEY LASER III 1243 US WITH DETECT
- K073383 — WELL LEAD REINFORCED ENDOTRACHEAL TUBE
- K073678 — VARIOSURG
- K080200 — WATER WORKS DOUCHING DEVICE
- K080739 — ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
- K080778 — ENSPLINT TM BONE SCREW
- K081039 — LIPO CANNULA
- K081273 — ULTRACAPS S
- K081345 — AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
- K081669 — IMPROVED COMFORT-FIT NIGHTGUARD
- K081680 — NUCLEUS-X, MODEL 230X
- K081794 — MODEL 7340 ULTRASOUND SYSTEM
- K070779 — SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM
- K073341 — GENEX PUTTY
- K080097 — MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET
- K080642 — COMPREHENSIVE REVERSE SHOULDER
- K080689 — SPECTRA THERAPY SYSTEM A1000 LASER DEVICE
- K080797 — HUMIDAIRE 2I
- K080804 — BUSSE PLASTIC LOR SYRINGE
- K081260 — KIMBERLY-CLARK *LAVENDER* NITRILE POWER-FREE EXAM GLOVES
- K081329 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS
- K081356 — OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
- K081781 — NUWAV
- K080647 — ACCIN BIPOLAR HEAD SYSTEM
- K080672 — BIRTHTRACK
- K081015 — CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
- K080496 — MOSAIC ECO2 LASER SYSTEM
- K081043 — LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
- K081683 — LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
- K053310 — VASCON ROAMER MICROCATHETER
- K070888 — COMBI 8 MAX
- K073500 — ACTIVE ANTERIOR CERVICAL PLATE SYSTEM
- K073621 — INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
- K073693 — COSTORSOL
- K080199 — SYMMETRIC TOTAL KNEE SYSTEM
- K080224 — KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK
- K080287 — ONCOBIONIC BIPOLAR ELECTRODE
- K080451 — UNIBLATE ELECTROSURGICAL DEVICE
- K080538 — IDEAL LIFE POD (MODEL ILP 0001)
- K080972 — ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP
- K081158 — ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
- K081373 — EVOLVE EPS SYSTEM
- K081391 — VIP ANTERIOR CERVICAL PLATE SYSTEM
- K081567 — VERTEBRON SSP CERVICAL PLATING SYSTEM
- K081598 — SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTURE
Data sourced from openFDA. This site is unofficial and independent of the FDA.