FDA 510(k) clearances — page 577
clearances on record, most recent first.
Clearances — page 577
57,601–57,700 of 175,825- K072717 — DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
- K072765 — PASSEO 18
- K072804 — COMPREHENSIVE RS SHOULDER SYSTEM
- K073005 — ELITE GLASS
- K073210 — MODIFICATION TO: T-PORT HP INFUSION PORT
- K073248 — MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEM
- K073394 — SMARTLIPO LASER
- K071562 — D3 HEMATOLOGY ANALYZER, MODEL D3
- K071942 — MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
- K072510 — VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2
- K072637 — DIVO
- K072721 — LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC
- K072766 — PVMED DDR 2520 DIGITAL IMAGING SYSTEM
- K072835 — LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK
- K073272 — WORKSTATIONONE BREAST IMAGING WORKSTATION
- K073273 — EQUAL DOSE 1.0
- K072226 — IMPIX SPACER
- K072267 — TOTAL HIP SURGETICS NAVIGATION SYSTEM
- K072473 — CHASE MR SYSTEM
- K072587 — CYTORI AFT SYSTEM
- K072601 — OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
- K072785 — TWINFIX FT PK
- K072883 — ICE-SENSE
- K072890 — STASILON FR
- K073033 — LEGACY DENTAL IMPLANTS
- K073059 — PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
- K073083 — VITEK 2 GRAM NEGATIVE PIPERACILLIN
- K063845 — ADVIA CHEMISTRY TOTAL BILIRUBIN_2
- K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X
- K070021 — ITALITE , MODEL 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0
- K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC
- K070558 — BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
- K070582 — BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
- K071164 — LIFE+CEL BATTERY
- K071878 — DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB
- K072118 — STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
- K072137 — AVITA BLUETOOTH BLOOD PRESSURE MONITOR, MODEL: BPM656ZB
- K072354 — GUIDEWIRE, MODEL G-V220-3527S AND OTHERS
- K072374 — COMPASS
- K072393 — ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
- K072513 — DM-EMG
- K072550 — SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301
- K072651 — CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM
- K072690 — HEMAWAY SEAT
- K072776 — THE CROSSER SYSTEM
- K072840 — ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
- K072892 — TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5
- K072929 — LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
- K073009 — ONEPORT SURGICAL TROCAR SYSTEM
- K073044 — HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7
- K073107 — VALENCIA SKIN APPLICATOR SET, MODEL: 189.701
- K073148 — IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS
- K073157 — VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
- K073226 — CINCH KNOTLESS FIXATION IMPLANT SYSTEM
- K073264 — D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005
- K073353 — DO-ALL DENTAL HANDPIECE LUBRICANT
- K073372 — ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)
- K071093 — SAN SHIH POWERED MUSCLE STIMULATOR, MODEL 202
- K071219 — ATHENA MULTI-LYTE GBM TEST SYSTEM
- K072264 — FASTPACK HCG IMMUNOASSAY
- K072330 — CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
- K072531 — LEGION STEM WITH HOLES
- K072649 — SPI SYSTEM DENTAL IMPLANTS
- K073123 — CARDICA C-PORT FLEX-A DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000150
- K073126 — EXPEDIUM SPINE SYSTEM
- K073151 — MANTIS SPINAL SYSTEM
- K072558 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
- K072577 — BISICO IMPRESSION SILICONES & ALGINATES
- K073125 — VALEO VBR
- K073141 — SPI ART ABUTMENT
- K073271 — ORTHOGON
- K070757 — MICROPROTEIN REAGENT SET
- K071712 — LEUKO EZ VUE
- K071795 — NUVASIVE COROENT SYSTEM
- K071941 — MEMOMETAL BONE ANCHORS
- K072622 — STANDOUT 2
- K072746 — E-1 ESTHETIC COMPOSITE SYSTEM
- K072750 — SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066
- K072830 — RM BOND, MODEL J032
- K073300 — MILESMAN PREMIUM
- K060846 — THERAPEUTIC MASSAGE COMPANION
- K070053 — EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2
- K070824 — CREATININE (ENZYMATIC)
- K071697 — NEURONAV SYSTEM AND NEURONAV DRIVE
- K072344 — APL MEDICAL SYSTEM
- K072453 — CRY-AC TRACKER, MODEL(S) B-700T, AND B-800T
- K072878 — MODIFICATION TO: LOCATOR IMPLANT ANCHOR
- K073147 — SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08
- K073170 — R-PORT II LAPAROSCOPIC ACCESS DEVICE
- K070015 — COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
- K070705 — MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
- K070900 — FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
- K071202 — DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
- K071265 — SMARTCHECK INR SYSTEM
- K071667 — SYNTHES VECTRA-ONE SYSTEM
- K072115 — ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
- K072325 — BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
- K072783 — SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH
- K073017 — STRYKER STRI-SHIELD FLYTE TOGAS
- K073100 — INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
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