FDA 510(k) clearances — page 839
clearances on record, most recent first.
Clearances — page 839
83,801–83,900 of 176,637- K000783 — DIRECT TIBC CALIBRATOR
- K000805 — KAVO K.E.Y. LASER 1242
- K000816 — SHARP BRAND ACUPUNCTURE NEEDLES
- K000939 — HTF-HEPES
- K000940 — HUMAN SERUM ALBUMIN (HSA)
- K001248 — MULTI-PULSE 2000
- K980672 — SIMPLEX AIRBRATOR (SAB-7)
- K991327 — MEDI-CULT FLUSHING MEDIUM
- K991332 — MEDI-CULT SPERM PREPARATION - MEDIUM
- K992592 — A-MINIATURE CENTRIFUGAL BLOOD PUMP SYSTEM, MODEL CPB 2000
- K993816 — BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
- K993841 — CEMSTOP CEMENT RESTRICTOR
- K994126 — MODULAR-PLUS REVISION STEM
- K000140 — CLINI-DENT
- K000333 — STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD
- K000348 — COLORADO MICRODISSECTION NEEDLE
- K000349 — MOTORIZED MICRO MULTILEAF COLLIMATOR
- K000380 — FOTOMASTER
- K000395 — EINSTEIN PROCESSING AND REVIEW WORKSTATION
- K000438 — MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
- K000547 — ATR TECNIKA
- K000579 — TEMPO AQUA ANGIOGRAPHIC CATHETER
- K000681 — AU5, AU6
- K000745 — SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K000771 — DIMAX 2
- K000778 — ENTEC REFLEX WAND 55, MODEL E4055-01, E4045-01
- K000896 — POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS
- K000966 — 4631 DUO DELIVERY SYSTEM
- K000967 — 4635 ASSISTANT'S INSTRUMENTATION
- K000968 — 3181 DUO DELIVERY SYSTEM
- K001057 — AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
- K001083 — GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4
- K001140 — IDS5 IMAGE DISPLAY SYSTEM
- K001153 — MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM
- K001238 — LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
- K991422 — POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K993520 — H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K000320 — SONOS AIRES 600 (SA-600)
- K000327 — WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
- K000480 — ACTIVE ELECTRODE MONITORING SYSTEM
- K000545 — SENTRY EXPANDING INTRODUCER SHEATH (EIS)
- K000663 — KRONNER LOW PROFILE SCOPE HOLDER
- K000665 — TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
- K000672 — HELIODENT VARIO
- K000781 — DIRECT TIBC KIT
- K000900 — ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
- K001266 — VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA
- K982101 — SHELHIGH NO-REACT DURA SHIELD
- K994380 — CEDIA DAU AMPHASSURE ASSAY
- K000506 — BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
- K000518 — MACROPRO GEL
- K000519 — GLUCANPRO
- K000682 — SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
- K000982 — A100 AESTHETIC DIODE LASER
- K001079 — RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO
- K001085 — MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
- K001132 — BONE BIOPSY NEEDLE
- DEN000006 — EROS-CLITORAL THERAPY DEVICE (CTD)
- K000299 — DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D
- K000357 — EZ CONNECT RESIN
- K000385 — OPTI-FREE EXPRESS LENS DROPS
- K000428 — DIXI 2
- K000445 — MEDTRONIC MODEL 7499 EXTENSION
- K000541 — SILK NONABSORBABLE SURGICAL SUTURES, USP
- K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
- K000667 — POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM
- K000668 — POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA
- K000684 — SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
- K000689 — UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES
- K000891 — STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES
- K000954 — KERR GEL ETCHANT
- K001020 — 8100 VITAL SIGNS MONITOR
- K001047 — GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)
- K001051 — RX EVEREST
- K001094 — SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES
- K001136 — CORDIS INTRODUCER GUIDE
- K001216 — POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K001270 — GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
- K001279 — GT990402 DIGITAL THERMOMETER
- K993149 — PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
- K993564 — POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
- K993619 — CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK
- K993756 — HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES
- K994372 — MODEL 120
- K000227 — UMBICUT
- K000537 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
- K000539 — NYLON NONABSORBABLE SURGICAL SUTURES, USP
- K000540 — POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
- K000701 — HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER
- K000712 — PORTABLE INTENSIVE CARE UNIT, MODEL PIC
- K000832 — STEROTACTIC LOCALIZATION DEVICE (SLD)
- K000942 — CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
- K001006 — THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
- K001010 — ASCENT KNEE REVISION FEMORAL STEM
- K001015 — ELECSYS THYROGLOBULIN CALCHECK
- K001019 — TI500 GLOBE-TROTTER TRANSPORT SYSTEM
- K001048 — LIGHT BOND (QUICK CURE)
- K001138 — AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
- K994171 — MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
- K000096 — ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
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