FDA 510(k) clearances — page 807
clearances on record, most recent first.
Clearances — page 807
80,601–80,700 of 175,825- K003615 — STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
- K003644 — EYETECT TREMOR MONITOR UNIT (TMU)
- K003669 — KAPPA IMMAGE FREELITE KIT
- K003671 — LAMBDA IMMAGE FREELITE KIT
- K003737 — POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS)
- K003840 — CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
- K003930 — FLEXTIME MAGNUM 360
- K010048 — M2376A DEVICELINK SYSTEM
- K010056 — UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450
- K010091 — EEG WITH VIDEO, MODEL EX-NW
- K010098 — MODIFICATION TO CAVERMAP SURGICAL AID
- K010099 — ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER
- K010142 — OCO DENTAL IMPLANT
- K990284 — BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
- K002445 — LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES
- K002822 — VERTEX SYSTEM
- K010003 — EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
- K002231 — LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT
- K003394 — APPALEAD GW+03XXXXXXR SERIES
- K010042 — CT PERFUSION 2
- K001543 — BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
- K002273 — STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE
- K002338 — LIQUIDERM LIQUID ADHESIVE BANDAGE
- K002791 — NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
- K003380 — BIOTEQUE VAGINAL DILATOR
- K003397 — COLLES C SERIES FRAME STERILE PACK
- K003467 — CHASE CARDIOVASCULAR PATCH
- K003519 — YASARGIL PERMANENT ANEURYSM CLIPS
- K003577 — STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
- K003693 — DIRECT BILIRUBIN
- K003948 — EPI-DERM SILICONE GEL SHEETING
- K010078 — GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
- K003375 — CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX
- K002375 — STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
- K002426 — THE BIOPLATE REGID FIXATION BONE PLATING SYSTEM FOR CRANOMAXILLOFACIAL SURGERY
- K002652 — SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
- K002719 — FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A
- K003055 — MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K003407 — SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER)
- K003409 — ELECSYS FSH CALSET II
- K003653 — STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
- K003670 — PATIENT DRAPE, SURGICAL
- K003682 — MEDCOMP Z-CATH
- K003748 — TIANXIE
- K003906 — MODIFICATION TO FLUROTEX SURGICAL MESH
- K003917 — MODIFICATION TO FLUOROTEX II SURGICAL MESH
- K003934 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K003982 — TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR
- K010054 — GUTHRIE SHIELD BLUE LATEX EXAMINATION GLOVES, POWDERED WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K010072 — POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
- K001624 — GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
- K001678 — PVA FOAM EMBOLIZATION PARTICLES
- K001961 — STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE
- K001985 — INTRODEUCE DOUBLE LUMEN INTRODUCER
- K002007 — SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
- K003250 — FMP METAL/METAL ACETABULAR INSERT
- K003376 — WELCH ALLYN 11800 OPTHALMOSCOPE
- K003385 — TWILITE, TWILITE WHITE
- K003392 — CARDIO MONITOR CENTER VISION; MODEL S-CV7-00
- K003460 — PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM
- K003541 — DENLASER, MODEL 800
- K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
- K003690 — HARDYDISK SULFISOXAZOLE
- K003696 — STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
- K003941 — ELECSYS HCG STAT CLASET II
- K004007 — DR180+OXY
- K004013 — IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY
- K003351 — PARSFIX CABLE-SCREW SYSTEM
- K003427 — ZINC PHOSPHATE CEMENT
- K003487 — STIMATE N601 TENS
- K003511 — KENDALL-LTP TURNER SAVE-A-LINE
- K003904 — POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
- K003921 — DYRACT CEM LCI COMPOMER
- K003990 — SOFRADIM PARIETEX SURGICAL MESHES
- K003997 — INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
- K004027 — STRYKER REMOTE SURGICAL PLANNING SYSTEM
- K010034 — DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
- K010038 — NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE
- K991618 — BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR
- K994060 — THE BIOPLATE RESORBABLE BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY, BIOLACTATE
- K002235 — HORIZONS ERCP CANNULA
- K002236 — HORIZONS PAPILLOTOME
- K002968 — MEDLINE STERILIZATION WRAP
- K003426 — ALGINATE IMPRESSION MATERIAL
- K003573 — DIFFUSION TENSOR IMAGING OPTION
- K003628 — MAGNETOM RHAPSODY SYSTEM
- K003639 — VITREA 2 CT PERFUSION OPTION
- K003791 — CAVEX TEMPORARY CEMENT
- K003872 — GUTHRIE PRIME POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
- K003883 — MOLINA ORBITAL MALAR DISTRACTOR
- K010060 — RITA STARBURST XLI ELECTROSURGICAL DEVICE
- K002011 — GLUTARTEST 1 REAGENT STRIP
- K002621 — GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
- K002624 — GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM
- K002930 — INSTACCULT
- K003042 — V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT
- K003323 — COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205
- K003341 — EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS
- K003342 — WAKO CRP-UL, CRP-UL CALIBRATOR SET
- K003459 — PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW
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