FDA 510(k) clearances — page 827
clearances on record, most recent first.
Clearances — page 827
82,601–82,700 of 175,890- K001629 — DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM
- K001718 — MILLENNIA ACUPUNCTURE NEEDLE
- K001769 — VITROS CHEMISTRY PRODUCTS CREA DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT
- K001786 — TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
- K992606 — CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
- K994410 — INSTANT-VIEW MARIJUANA (THC) URINE DIP STRIP TEST
- K001026 — 3D-MSPECT
- K001067 — DADE BEHRING COAGULATION ANALYZER (BCT)
- K001286 — ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10
- K001303 — BREAST IMMOBILIZATION DEVICE MR-BY 160
- K001311 — SYNTHES (USA) ORIBITAL MESH PLATES
- K001312 — MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL
- K001360 — SIGNUM
- K001477 — AURELUX Y 84 PREMIUM
- K001478 — AURECAST SUPER INLAY
- K001559 — CALCIUM SULFATE PELLETS
- K001711 — M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1
- K001733 — ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES
- K991331 — MEDI-CULT M3 MEDIUM
- K991334 — MEDI-CULT HYALURONIDASE;
- K992935 — OCD2001
- K993125 — SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM
- K993176 — MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
- K993625 — INSUFFLATION NEEDLE- 120MM, MODEL 900-200
- K000754 — QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT
- K000801 — PC COATED FLUOROPLASTIC VENT TUBES
- K001484 — CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838
- K001567 — ADVANTAGE THC TEST
- K001632 — OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009
- K001737 — OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM
- K994239 — ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
- K000313 — TEARAWAY INTRODUCER SHEATH
- K000433 — PBN HYSTERO-SALPINGOGRAPHY CATHETER SET
- K000543 — CONTEMPRO-MIST
- K000844 — ABSOLUTE HCG PREGNANCY TEST
- K000890 — CHAD THERAPEUTICS OXYMATIC MODEL 401
- K000892 — DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES
- K000947 — ULTRASTIM ELECTRODE, MODEL US4040
- K000955 — PLACER MODEL 6232 STEERABLE STYLET
- K000972 — SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS
- K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND
- K001463 — SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
- K001532 — DYNA-LOK CLASSIC SPINAL SYSTEM
- K001592 — ECHOCOM, IMAGECOM, DOKUCOM
- K001039 — THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP
- K001082 — STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100
- K001084 — TRANS FX ADJUSTABLE PIN TO BAR CLAMP
- K001545 — PIPET CURET
- K990060 — MACH 7
- K991999 — STERRAD 100S STERILIZER
- K000893 — AC POWERED THERMAL CAUTERY UNIT
- K001068 — NBS CONNECTING TUBE SET
- K001112 — GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC
- K001262 — THERMAL CAUTERY FORCEPS
- K001273 — STARION INSTRUMENTS POWER POINT CAUTERY CLAMP
- K001507 — MICROPERFORATION INSTRUMENT
- K001593 — MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL
- K001660 — MALLORY HEAD MODULAR CALCAR
- K001713 — HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA
- K994209 — STOCKERT V142 SERIES VENOUS CANNULAE WITH LIGHTHOUSE TIP
- K000237 — EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION
- K000627 — SCANDINAVIAN IVF SCIENCES AB, HYBASE-1
- K000981 — CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX
- K001012 — DIGITAL INTEGRATION SYSTEM, DIS2000
- K001113 — IVC THREE BLASTOCYST MEDIUM, CAT # 2007
- K001309 — HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250
- K001326 — NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
- K001475 — HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR
- K001485 — HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES
- K001584 — METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT
- K001620 — METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN
- K001762 — PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
- K992532 — VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
- K000072 — DORNIER MEDILAS D SKINPULSE
- K000687 — THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
- K001252 — MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651
- K001284 — STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
- K001343 — EUDERMIC PF POWDER-FREE SURGICAL GLOVES
- K001434 — 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE
- K001529 — POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA
- K001534 — PINNACLE ACETABULAR SYSTEM
- K001549 — MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
- K001594 — 3.5 MM LAPAROSCOPE (LG100, LG103)
- K993335 — SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
- K993518 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL
- K000336 — RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
- K000358 — MULTI ADJUSTABLE FACE MASK
- K000377 — MASIF POWDER-FREE PATIENT EXAMINATION GLOVES
- K001034 — MODEL APS ALTERNANS PROCESSING SYSTEM
- K001114 — 3M QUIK TEMP TEMPORIZATION MATERIAL
- K001178 — CEDIA DAU 6-ACETYLMORPHINE ASSAY
- K001210 — HI-RES 9000 PHASED ARRAY CAROTID COIL
- K001287 — EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
- K001331 — SYNERGY HEAD/NECK COIL
- K001474 — TERUMO U-100 INSULIN SYRING
- K001488 — NARKOMED MRI , NM-MRI
- K001557 — LAXTEX POWDERED EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
- K001574 — DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600
- K993316 — UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE
- K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES
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