FDA 510(k) clearances — page 602
clearances on record, most recent first.
Clearances — page 602
60,101–60,200 of 176,637- K070908 — SMITH & NEPHEW KINSA RC SUTURE ANCHOR
- K070997 — DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX
- K071036 — MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM
- K071061 — ABSORBATACK AND APPLICATOR
- K071189 — CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
- K071295 — 100W CERALAS D 980NM DIODE LASER
- K060968 — STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
- K070003 — POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)
- K070242 — SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-05
- K070840 — GVC-100
- K070861 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
- K070868 — LMS-LUNG/TRACK
- K071048 — RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537
- K070147 — INTERGRO ORAL
- K070427 — DUPEL TRANSPORT IONTOPHORESIS SYSTEM
- K071000 — MYRIAN
- K071068 — BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197
- K062011 — MODIFICATION TO FLOWSCREEN
- K062572 — CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE
- K062724 — ACCUPULSE PULSE OXIMETER
- K063634 — RTR SYRINGE
- K063638 — MODIFICATION TO PROXIS SYSTEM, MODEL EPS 101
- K063693 — FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
- K070313 — MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- K070318 — SKIPPI POWERED WHEELCHAIR FOR CHILDREN
- K070347 — ALLOFIX PUSH-IN ANCHOR
- K070363 — FETCH ASPIRATION CATHETER
- K070591 — REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
- K070646 — ADHESE ONE
- K070677 — COLORISE
- K070860 — MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN
- K070883 — DURACON X3 CS TIBIAL INSERT
- K071041 — COAGUCHEK XS PLUS SYSTEM
- K071073 — SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE
- K071092 — ASNIS MICRO CANNULATED SCREW
- K063789 — WN SYNOCTA GOLD ABUTMENT
- K070086 — SENSACARE MODEL SAA-102 ARM TYPE DIGITAL BLOOD PRESSURE MONITOR
- K070702 — FUSION RESIN CEMENT AND CORE KIT
- K070821 — POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE
- K071015 — OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
- K071037 — SPY INTRA-OPERATIVE IMAGING SYSTEM, MODEL SP2000
- K071154 — SUPERSTAR 0.35T MRI SYSTEM
- K062395 — ACCU-CHEK SMART PIX
- K062475 — LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
- K062943 — POLYSMITH SLEEP SYSTEM, MODEL NTI5498
- K063454 — POGS, MODEL 33C
- K063584 — STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937
- K063680 — SHARPOINT PDO (POLYDIOXANONE) SUTURES
- K063690 — COLIN PRESS MATE, MODEL BP S510
- K070437 — PRO-DENSE BONE VOID FILLER
- K070693 — AURAVUE PIT & FISSURE SEALANT
- K070829 — SYNEPIX 4600 DETECTOR
- K070993 — TOPAS SYSTEM
- K070994 — EAGLE + ANTERIOR CERVICAL PLATE SYSTEM
- K071008 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
- DEN060009 — 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE
- K063742 — RESONANCE METALLIC URETERAL STENT
- K070328 — BIPAP SYNCHRONY WITH AVAPS
- K070441 — METASURG SUBTALAR IMPLANT
- K070529 — AFF (MARK I) VOLUMETRIC INFUSION PUMP
- K070755 — INTERWORKS
- K070830 — MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING)
- K070996 — 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER
- K071106 — ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399
- K071134 — SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM
- K071162 — AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS
- K062096 — KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
- K063363 — FIRMGRIP PERIPHERALLY INSERTED CATHETER DEVICE
- K063545 — MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
- K063802 — LENSTEC LC INJECTION SYSTEM
- K070068 — NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS
- K070362 — SURFLO WINGED INFUSION SET
- K070452 — VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
- K070475 — MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM
- K070593 — TRACKRECORD DATA MANAGEMENT SOFTWARE
- K070612 — TOP-RANK ADHESIVE ELECTRODE
- K070642 — AERONEB PROFESSIONAL NEBULIZER SYSTEM
- K070715 — NASOPORE EAR
- K070740 — CHAD THERAPEUTICS BONSAI MODEL 800
- K070823 — GROWTH CONTROL PLATING SYSTEM
- K070326 — NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
- K061257 — DBEST HCG PANEL TEST KIT
- K062784 — SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402, MT-403 AND MT-405)
- K063752 — LIFESENSE, MODEL LS1-9R
- K070054 — FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
- K070240 — CARTO XP EP NAVIGATION SYSTEM, VERSION 9
- K070289 — ACQUASEAL BENZ
- K070331 — UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES
- K070368 — TRIO PLATE SYSTEM, TRIO SPINAL FIXATION SYSTEM, TRIO+ SPINAL SYSTEM
- K070393 — LAGWIRE SYSTEM
- K070399 — 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES
- K070527 — ARCUATE VERTEBRAL AUGMENTATION SYSTEM
- K070609 — APEX MEDICAL XT1 CPAP, MODEL 9S-005
- K070614 — CORSCREEN
- K070615 — ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
- K070626 — SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
- K070681 — NEXT GENERATION ANTERIOR CERVICAL PLATING SYSTEM
- K070741 — CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
- K070963 — REUNION HA FRACTURE STEM
- K071065 — ORTHADAPT BIOIMPLANT
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