FDA 510(k) clearances — page 934
clearances on record, most recent first.
Clearances — page 934
93,301–93,400 of 175,890- K972766 — PIVOTING COMPENSATING FILTERS FOR THE HEAD
- K964784 — SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
- K971632 — TICARCILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K971867 — ALICE 4R SYSTEM
- K972005 — REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
- K972182 — ABBOTT STREP A CONTROLS
- K972482 — REAADS PROTEIN S ANTIGEN TEST KIT
- K972627 — PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
- K972819 — VIGIL TDM CONTROLS
- K942685 — ECG REVIEW STATION
- K963520 — IMZ TWIN PLUS SCREW
- K970511 — DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
- K970660 — DERMAGRAN WOUND MANAGEMENT SYSTEM
- K971021 — CHASE PHRENIC NERVE PAD
- K971152 — ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
- K971657 — ACCURUN 121 HAV IGM POSITIVE CONTROL
- K971796 — LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
- K971827 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764
- K971828 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
- K971850 — SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES
- K971881 — COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS
- K971918 — AMERIGEL OINTMENT SATURATED WOUND DRESSING
- K971977 — KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE
- K971982 — KARL STORZ MODEL 203020 20 EQUIMAT
- K972032 — VISUALINE II METHAMPHETIMINE
- K972048 — ACCURUN 117 HBEAG POSITIVE CONTROL
- K972086 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
- K972108 — ALTA INTRAMEDULLARY ROD SYSTEM
- K972129 — CHLAMYDIATROL AG
- K972209 — SPECTROLYSE HEPARIN (ANTI-IIA)
- K972235 — PRECICONTROL TUMOR MARKER 1 AND 2
- K972250 — ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
- K972797 — TOOL-LESS WHEEL CHAIR
- K963481 — ANODYNE CC
- K964219 — ZIP CONDOM CATHETER
- K964431 — ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS)
- K964444 — QUICKLOCK ORTHOPAEDIC TARGETING SYSTEM
- K965066 — ARRHYTHMIA MAPPING SYSTEM (8100/8300)
- K970145 — PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
- K971305 — FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEM
- K971962 — OSTEO KIRSCHNER WIRES
- K972154 — COHEN DISTRACTOR
- K972166 — GUERRERO - BELL DISTRACTOR
- K972327 — METAGEN ACTIVELOCK CERCLAGE SYSTEM
- K972420 — LORENZ PECTUS SUPPORT BAR
- K972504 — MVM 3.3 MM MICROENDOSCOPE
- K962271 — ELECTROSURGICAL ELECRTRODES
- K963925 — THROMBOLYTIC BRUSH CATHETER
- K964424 — ROTAVIRUS EIA
- K964571 — VISION CARDIOPLEGIA DELIVERY SYSTEM
- K964831 — SURESCAN
- K970027 — FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005
- K970695 — ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
- K971183 — GOLD FINGERS
- K971737 — CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER
- K971812 — PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP
- K971878 — VANTAGE 2.1 EXSPECT
- K972053 — PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM
- K972337 — DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA
- K972405 — QUIKPAC II ONE STEP OPIATE TEST
- K972454 — OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
- K972618 — QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)
- K972758 — BACTEC MYCO/F-SPUTA CULTURE VIALS
- K964616 — QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT
- K965221 — RANSFORD CERVICAL FIXATION SYSTEM
- K970962 — JMS AV FISTULA NEEDLE
- K971406 — ACCURUN 120 HAV IGG POSITIVE CONTROL
- K971715 — SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS
- K971738 — ENDOPATH RESPOSABLE TROCAR SYSTEM
- K971807 — IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL
- K971890 — RECOVERY PROTRUSIO CAGE
- K971922 — INNOVASIVE 2.8MM AND 3.5MM ROC EZ SUTURE BONE FASTENER
- K972307 — ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL
- K972716 — SYNERMED TOTAL BILIRUBIN REAGENT KIT
- K955477 — HI-TEC CO2 INSUFFLATOR TYPE 1300
- K962777 — AMR MINI-LAPAROSCOPE
- K962951 — MODEL HS-2 TENS DEVICE
- K963290 — COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
- K963521 — IMZ TWIN PLUS - CYLINDER
- K964804 — FLEXILOG LS
- K970014 — TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)
- K970344 — MDILOG, MODEL MDC-511
- K971629 — PATIENT LATEX EXAMINATION GLOVE (PREPOWDERED)
- K971705 — IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED
- K971745 — BARD COMPOSITE PROSTHESIS
- K971837 — VERRES NEEDLE, CANNULA FOR M820, CANNULA W/TRUMPET VALVE FOR M 820
- K971853 — ENDOVIEW SPPHIRE LENS SET
- K971929 — AMSINO URINARY LEG BAG
- K971939 — SMITH & NEPHEW SUTURE COLLET
- K971948 — PATIENT RESTRAINT
- K972245 — TOM CAT F.L., TOM CAT S.L.
- K972278 — CYTOPLAST REGENTEX TITANIUM 250
- K972384 — AQ ONE STEP COCAINE TEST
- K972609 — VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
- K972721 — ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
- K962548 — BSM BONE SUBSTITUTE MATERIAL KIT
- K963451 — ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING
- K964017 — AFFINITY BLOOD PUMP SYSTEM
- K964226 — MEMORY STAPLE (20 SIZES AVAILABLE)
- K970575 — ELECTRO-LITE ELITE POWERED WHEELCHAIR
Data sourced from openFDA. This site is unofficial and independent of the FDA.