FDA 510(k) clearances — page 865
clearances on record, most recent first.
Clearances — page 865
86,401–86,500 of 176,637- K990903 — LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
- K991055 — OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
- K991089 — SYNTHES CERVIFIX SYSTEM
- K991198 — DYNA-LOK PLUS SPINAL SYSTEM
- K991507 — KANGNIAN BRAND ACUPUNCTURE NEEDLE
- K991508 — ACUMASTER BRAND ACUPUNCTURE NEEDLE
- K991726 — BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
- K991729 — FERRIS POLYOSTOMY STERILE WOUND DRESSING
- K991989 — MITAKA POINT SETTER
- K991995 — SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
- K992024 — SUPER PORCELAIN TI-22
- K992067 — BELLEGLAZE
- K992071 — TRANSVAGINAL ULTRASOUND PROBE HOLDER DEVICE
- K992198 — URETHANE PICC LINE MODEL UPICS-
- K992236 — LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA
- K992283 — ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
- K992304 — NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
- K992457 — SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION
- K992485 — MONOPOLAR ELECTRODES AND CABLES
- K992516 — DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
- K992567 — ANATOMICAL BANKART TACK, MODEL 523520A
- K991670 — SILVERSTEIN MICROWICK
- K991841 — HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
- K991847 — THERMOFLEX SYSTEM
- K991854 — OSTEOPLAST, MODEL POP200
- K991925 — PASCO MIC AND MIC/ID PANELS
- K992140 — PICCOLO METLYTE 7 REAGENT DISC
- K992222 — FLUOROPLASTIC VENTILATION TUBES
- K992278 — HEPARIN CONTROL PLASMA LEVEL 1
- K992279 — HEPARIN CONTROL PLASMA LEVEL 2
- K992395 — URINE DRUG SCREENING CONTROL
- K992397 — ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
- K992589 — RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY
- K983719 — BIOSHIELD EXPRESS STERILIZATION WRAP
- K990777 — MED-RX EXTENSION SETS
- K991698 — REDI-TEST PCP
- K991823 — N-395 PULSE OXIMETER, MODEL N-395
- K991888 — MINIJECT
- K992062 — SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
- K992165 — HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
- K992248 — POST CEMENT HI-X
- K992494 — FLEXIFLO ENTERAL FEEDING TUBE
- K992496 — POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
- K992497 — POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
- K990037 — NEPTUNE WASTE MANAGEMENT SYSTEM
- K991942 — AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
- K992181 — TRIP TONOMETRY CATHETER, 8F
- K992349 — VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
- K992477 — ROTOSNARE
- K992608 — ATC OPTION FOR EVITA 2 DURA AND EVITA 4
- K992663 — ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM
- K992672 — BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
- K980244 — AEQUALIS SHOULDER PROSTHESIS
- K991007 — K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
- K991254 — QS DELIVERY SYSTEM
- K991559 — MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD
- K991896 — MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA
- K991943 — MRGP OPTICAL TRACKING UNIT
- K992104 — PARSET, MODEL A10001E
- K992107 — BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
- K992123 — SCIMED IMPULSE ANGIOGRAPHIC CATHETERS
- K992299 — HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
- K992470 — ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM
- K992644 — SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
- DEN990005 — THE 3PM EGG MACHINE
- K990236 — MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT
- K991083 — RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
- K991312 — SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
- K991570 — JOBST READY-TO-WEAR ARM SLEEVES
- K991830 — CAPSULAR SHRINKAGE ELECTRODE
- K991909 — DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
- K991932 — INTRAVASCULAR ADMINISTRATION SET
- K991985 — COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET
- K992132 — CHOLESITE TEST SYSTEM
- K992158 — LACTOSORB SHEETS
- K992361 — PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
- K992441 — ADVANTA GRAFT
- K992443 — ADVANTA GRAFT
- K992620 — BLULAZE
- K983886 — POCKIT HSV 2 RAPID TEST
- K984338 — JOSTRA HL-20 TWIN PUMP
- K990230 — ELECTRO-NERVE STIMULATOR TENS, MODEL LX
- K990630 — SAS ADENO TEST
- K991119 — TILT/RECLINER FOR POWER WHEELCHAIRS, MODEL 2G
- K991664 — LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
- K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS
- K991739 — COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
- K991819 — MAGNATEK 30
- K991828 — STREP B OIA
- K991892 — TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
- K991941 — EBI XFIX DFS RAIL SYSTEM
- K992032 — ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033
- K992081 — VARIOUS ANSELL TRADENAMES OR PRIVATE LABEL
- K992086 — OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
- K992149 — GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405
- K992313 — XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
- K992324 — FUNNEL TROCAR
- K992413 — ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
- K992490 — B2C HIP SYSTEM
- K992506 — MINI 6800 DIGITAL MOBILE C-ARM
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