FDA 510(k) clearances — page 442
clearances on record, most recent first.
Clearances — page 442
44,101–44,200 of 175,770- K111941 — CHOYANG THERMAL MASSAGER
- K112550 — CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
- K112915 — SPIRTIUS CUFF INFLATION SYRINGE
- K113006 — I-FUSE HAMMER TOE SYSTEMS
- K113696 — OPTOS ADVANCE
- K113714 — VPAP TX
- K113801 — VPAP ADAPT
- K120080 — SHASER HRS2 HAIR REMOVAL SYSTEM
- K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR
- K120333 — PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY
- K120587 — AMT T-FASTENER ANCHOR KIT
- K120604 — K-LASER
- K120612 — MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
- K120631 — PATIENT MONITOR
- K120899 — RANGE SPINAL SYSTEM, UNIT ROD
- K120964 — UPSTREAM GR CATHETER
- K121039 — COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
- K121380 — WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
- DEN120012 — CDC DENV-1-4 REAL TIME RT-PCT ASSAY
- K110644 — PRAEZIS PLUS
- K112165 — RHEA CUP
- K112491 — SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
- K112585 — TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM
- K112905 — COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
- K120079 — PRIMED TRACHEOSTOMY TUBES (MULTIPLE)
- K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
- K120150 — DUAL SPIKE TRANSFER DEVICE
- K120425 — PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
- K120559 — AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
- K120601 — GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O
- K120633 — MAYFIELD SKULL CLAMP
- K120767 — ES BOND
- K120811 — LEKSELL GAMMA KNIFE PERFEXION
- K120840 — LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
- K120895 — REMOTE PRESENCE SYSTEM
- K121232 — K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
- K121236 — PAX-DUO3D PLUS, PCT-5000
- K121239 — MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE
- K110632 — LUCENT OR LUCENT MAGNUM
- K111262 — ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP
- K111476 — CONTOUR TECHNOLOGY MUSCLE STIMULATOR
- K111575 — HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX
- K112800 — SUNTOUCH TOPICAL HEMOSTATIC DRESSING
- K113287 — SOMATOM PERSPECTIVE
- K113440 — HIGH FIVE
- K120179 — REACH SURGICAL STAPLERS
- K120191 — PUSH-ON NEEDLE 30GX8MM
- K120284 — DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX
- K120487 — VANTAGE TITAN 3T
- K120515 — TEMPUS CERVICAL PLATE SYSTEM
- K120556 — VILET VILET QUICK
- K120579 — SOMATOM DEFINITION EDGE
- K120622 — PALOMAR VECTUS LASER
- K120879 — LEXUS CERVICAL FIXATION SYSTEM
- K120934 — PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
- K120976 — MANUKA IG
- K121109 — AERODR X70
- K121227 — MANUKA FILL
- K121384 — MYLABSOGNO
- K111862 — VIEWRAY SYSTEM
- K112527 — UNIVERSAL DIGITAL INTERFACE (UDI) 1717
- K112881 — NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
- K113103 — SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
- K120013 — TEMPSPAN CLEAR MATRIX
- K120042 — TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K120443 — NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE
- K120533 — BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES
- K120586 — CELL SAVER ELITE
- K121263 — TAPER SET HIP SYSTEM RDP STEM
- K121265 — AMPHIRION PLUS PTA CATHETER
- K120104 — VISIONSEARCH 1
- K120130 — FALLER TROCAR
- K120404 — MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
- K120419 — DYNA LOCKING ANKLE NAIL
- K120495 — IMPULSE AND EXPO ANGIOGRAPHIC CATHETER
- K120619 — ORTHODONTIC FLOWABLE BRACKET ADHESIVE
- K111450 — MIROCAM CAPSULE ENDOSCOPE SYSTEM
- K112457 — LEFORTE SYSTEM BONE PLATE & SCREW
- K112698 — CONCENTRIC BALLOON GOOGLE
- K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
- K113565 — MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN
- K113576 — DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM
- K113622 — ORION II CT CVC
- K120091 — R&D INNOVATION PEDICLE SCREW SYSTEM
- K120099 — RANGE SPINAL SYSTEM (MESA AND DENALI)
- K120299 — SRS ENDOSCOPIC STAPLING SYSTEM
- K120605 — PERMACOL SURGICAL IMPLANT
- K120698 — GENESIS II PS NON-MODULAR FEMORAL COMPONENT
- K120911 — XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
- K120928 — SYNTHES MATRIX SYSTEM
- K121143 — LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
- K121207 — EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM
- K121237 — BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE
- K112322 — RESTORELLE POLYPROPYLENE Y MESH
- K113253 — ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT
- K113281 — MRI SYTEMS
- K113510 — EVOLUTION COLONIC STENT SYSTEM
- K120059 — LIQUID BANDAGE
- K120440 — PRESTO BREAST BIOPSY DEVICE
- K120489 — TISSUE OF ORIGIN TEST KIT FFPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.