FDA 510(k) clearances — page 927
clearances on record, most recent first.
Clearances — page 927
92,601–92,700 of 175,890- K970839 — SERVO VENTILATOR 300A
- K971501 — SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
- K972686 — VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
- K972762 — CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
- K972910 — PORS ON LITE
- K973175 — TONGUE KLEAN
- K973376 — LORI/LORI, LORI-S (LORI STOCK AID)
- K973790 — ABC LINEARITY VERIFIERS
- K973791 — ABC CALIBRATION VERIFIERS
- K961008 — AUTOMIX 3+3/AS COMPOUNDER SYSTEM
- K962774 — OSTEOMED QUICKFIX
- K963136 — PACER MODEL 100 INFUSION CONTROLLER
- K964056 — RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
- K965112 — MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS
- K971628 — SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
- K971896 — GALILEO HIGH RESOLUTION MICRO COUPLER
- K972495 — ACCUMETER THEOPHYLLINE TEST
- K972607 — PLATALLOY
- K972664 — STORZ MILLENNIUM VISCOUS FLUID SYSTEM
- K972684 — INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM
- K972727 — CBALK-1000 BLADE
- K972796 — SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
- K972799 — DRIED GRAM-POSITIVE MIC/COMBO PANELS
- K972823 — MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETER
- K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE
- K972977 — INSULATOR WIRE GUIDE
- K973112 — ELECSYS DIGOXIN
- K973157 — LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
- K973488 — LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K973489 — LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K973557 — LUBRIGLIDE
- K962977 — MRI COMPATIBLE BIOPSY NEEDLES
- K964434 — SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
- K971281 — RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
- K971320 — CRE BALLOON DILATATION CATHETER
- K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
- K972130 — DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
- K972622 — STRAIGHT-IN BONE SCREW FIXATION SYSTEM
- K972629 — DEPUY AE TK2 HIP SCREW SYSTEM
- K972641 — DUAL OFFSET PERFECTA IMC HIP STEM
- K972813 — GAMMA LOCKING NAIL SYSTEM
- K972876 — GLUCOTREND BASIC SYSTEM
- K973015 — MULTITAK SS SUTURE SYSTEM
- K973062 — TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE
- K973075 — ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON
- K973177 — MAGO AUTOMATED EIA PROCESSOR
- K973418 — UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)
- K963913 — MD100 & MM150
- K963914 — CM & CM DS-7
- K970233 — GELBFISH ENDO-VAC SYSTEM
- K971273 — INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF
- K971712 — COEUR 130 ML ANGIOGRAPHIC SYRINGE
- K971877 — LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
- K972204 — ACU-RAY HF SERIES PORTABLE X-RAY UNIT
- K972569 — E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
- K972612 — DISSECTRON PORTABLE UNIT
- K972654 — MANIFOLD
- K972726 — SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
- K972778 — DEY VIAL SODIUM CHLORIDE 3%
- K972815 — PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
- K972922 — VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K
- K972926 — MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
- K972968 — ROTOGRAPH PLUS
- K972986 — ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
- K973073 — DRTS IMAGE INTENSIFIER DRAPE
- K973125 — MAMMOLOADER BY C.M.A. SRL
- K973219 — AMBER DU
- K973327 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
- K973329 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
- K973342 — DAR-3000B
- K973589 — LIQUID LDH-L REAGENT SET
- K971590 — TACTYLON CONDOM
- K971643 — RUSCH BRILLANT BALLOON CATHETER
- K972558 — BIPOLAR SCISSORS
- K972678 — MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS
- K972825 — OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
- K972847 — KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)
- K973086 — PLA-96P
- K973245 — TOKUSO REBASE MR. BOND
- K973629 — PRECINORM RF, PRECIPATH RF
- K972342 — REAADS PROTEIN C ANTIGEN TEST KIT
- K972561 — NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY
- K972811 — HOWMEDICA FULLY THREADED SCREWS
- K972974 — ACCUWELL T4-EIA
- K973074 — 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR
- K973126 — TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
- K973358 — MYOGLOBIN CONTROL SET
- K973367 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
- K973487 — CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964617 — GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
- K965226 — EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE
- K970456 — HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEM
- K970570 — NIVP3 (WINDOWS VERSION OF NIVP
- K971056 — MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION
- K971131 — FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
- K971198 — BABYTHERM 8004 BABYTHERM 8010
- K971257 — VTU-1 VACUUM ERECTION SYSTEM
- K971947 — INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY)
- K972169 — MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
- K972514 — LASEREX LP1532 PHOTOCOAGULATOR
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