FDA 510(k) clearances — page 563
clearances on record, most recent first.
Clearances — page 563
56,201–56,300 of 176,542- K080761 — BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES
- K081237 — CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT
- K081247 — TM-400
- K081468 — DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES
- K081558 — PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC
- K082005 — MODIFICATION TO HI-ART TREATMENT SYSTEM
- K082098 — SONOSITE MAXX SERIES ULTRASOUND SYSTEM
- K082143 — MICRO GUIDE CATHETER XP
- K082318 — CENTRICITY PACS IW
- K072950 — CYGNUS 12 LEAD ECG MODULE
- K073334 — OHMNISCAN NG
- K080643 — ELECSYS ANTI-TSHR CALCHECK
- K081048 — PINNACLE PELVIC FLOOR REPAIR KIT II
- K081075 — PAINSHIELD MD
- K081600 — STERIS RESERT XL TEST STRIP
- K081722 — YSIO
- K081983 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00
- K082009 — HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS
- K082030 — DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
- K082064 — RADVISION ET DIAGNOSTIC X-RAY SYSTEM
- K082067 — MSC LIPID CONTROL
- K082197 — RHYTEC, INC., PORTRAIT PSR
- K082294 — WESTAR SERIES DENTAL UNITS
- K081388 — GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
- K081393 — ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
- K081405 — XERACEM
- K081566 — SMITH & NEPHEW OXINIUM DH FEMORAL HEADS
- K081847 — PICASSO MASTER, ECT AND MASTER 3D
- K081899 — ANYRAY PORTABLE X-RAY SYSTEM
- K082099 — VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
- K082244 — PCA-8000A, MARK 11, PET / CT SYSTEM
- K073427 — MEDILAS D FAMILY LASERS
- K080102 — TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM
- K080259 — JMEA CANNULATED BONE SCREW SYSTEM
- K080510 — VIP PULMONARY FUNCTION SYSTEM
- K081657 — POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)
- K081679 — REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05
- K081875 — GENTIAN CYSTATIN C IMMUNOASSAY
- K081896 — BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
- K080641 — TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
- K080872 — AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ
- K081465 — AXIUM DETACHABLE COIL SYSTEM
- K081549 — RX ACCUNET LP EMBOLIC PROTECTION SYSTEM
- K082061 — INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER
- K082191 — CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
- K082274 — HAIDA MODEL HD11 MANUAL WHEELCHAIR
- K082288 — HAIDA HD21
- K072708 — ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
- K072974 — SURGIMESH XB
- K073444 — TRITON MEIDCAL TMED IV-SET
- K073579 — DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
- K081586 — REPROCESSED EXTERNAL FIXATION DEVICE
- K081853 — OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
- K080063 — MASS CASUALTY VENTILATOR, MODEL MCV100
- K080136 — INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105
- K080189 — TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX; VINYL,MODEL 99XXX
- K080530 — MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
- K080685 — HIPLOC COMPRESSION HIP SCREW
- K081038 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
- K081302 — RESCUE EXTERNAL IMPLANT SYSTEM
- K081365 — SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
- K081672 — C-INSIGHT
- K081757 — VERISTA IMAGING ISOCAM II GAMMA CAMERA
- K081951 — ANEROID SPHYGMOMANOMETER, MODEL KT-A01
- K082034 — MODIFICATION TO MERCI RETRIEVER
- K082075 — HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
- K082182 — AP 34 MULTI-THERAPY INFUSION PUMP
- K082185 — GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2
- K080544 — UNASSIGNED
- K081213 — BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
- K081526 — FLOWCARE TLG REAGENT
- K081535 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
- K081944 — MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
- K081982 — WATCH-PAT 200S-2 (WP200S-2)
- K073432 — TRAUSON BONE PLATE
- K080395 — SUNIVF DISHES
- K080710 — TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
- K081086 — PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0
- K081126 — PARIETEX COMPOSITE MONO PM MESH
- K081342 — REPROCESSED EXTERNAL FIXATION ACCESSORIES
- K081459 — CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
- K081837 — AVEA VENTILATOR
- K081936 — SOLEX CATHETER, MODEL SL2593
- K082025 — BODY-JET
- K082175 — MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION
- K082204 — SERIES SY DISPOSABLE ELECTROSURGICAL PAD
- K082218 — MAX ADJUSTING INSTRUMENT
- K080637 — POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
- K080926 — AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER
- K081390 — BIOACTIF OSTEOTRANS INTERFENCE SCREW
- K081647 — ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS
- K081695 — DMC COMPOSITE
- K081745 — ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL
- K081939 — OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY
- K081942 — NEUROCATH AG
- K082119 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0
- K073352 — WEBERNEEDLE BASIC LASER
- K080364 — FINDRWIRZ GUIDE WIRE SYSTEM
- K080533 — WINCO MODEL POWER SERIES LIFT CHAIR
- K080634 — ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495
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