FDA 510(k) clearances — page 863
clearances on record, most recent first.
Clearances — page 863
86,201–86,300 of 175,890- K982974 — DD URETERAL STENT, INTEGRAL STENT
- K983768 — MODIFICATION TO GAMMA GUIDANCE SYSTEM
- K991170 — RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
- K991420 — MODIFIED HAM'S F-10 WITH ALBUMIN
- K991421 — FREEZING MEDIUM - TEST YOLK BUFFER (TYB) WITH GLYCEROL, REFRIGERATION MEDIUM - TEST YOLK BUFFER 9TYB)
- K991626 — WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION
- K983631 — AUTO-PEEP MEASUREMENT DEVICE, MODEL # KC 9-P
- K983837 — HEDROCEL ACETABULAR CAGE SYSTEM
- K984640 — THERMAL ANGEL
- K990454 — BIO-INTERFERENCE SCREW
- K990496 — ANESFLOW-DUAL DRIP IV INFUSION SET
- K990602 — RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES
- K990965 — SYNTHES CERVIFIX SYSTEM
- K991122 — CRYO-MONO CRYOGRNIC SYSTEM
- K991169 — SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
- K991176 — OPUS TROPONIN I CALIBRATOR
- K991177 — OPUS TROPONIN I (CTN) TEST MODULES
- K991212 — MODIFICATION TO TRUZONE PEAK FLOW METER
- K991275 — WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
- K991457 — DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
- K991539 — EXCELL 22
- K991821 — NITRILE EXAMINATION GLOVE, POWDERED, BLUE
- K991939 — BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)
- K991953 — MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
- K992058 — BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
- K990461 — MCKINLEY SP DISPOSABLE INFUSION PUMP
- K991098 — DIFOTI SYSTEM
- K991242 — GLUCOMETER ELITE TEST STRIPS
- K991282 — COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES
- K991576 — ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K991582 — CHIRON DIAGNOSTICS ACS: 180 FOLATE
- K991663 — AST/SGOT
- K991666 — TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
- K992033 — MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL
- K984586 — FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS
- K990198 — AMIB7
- K990628 — GYRUS ENDOUROLOGY SYSTEM
- K991107 — SHADOW TRAYS
- K991118 — O.B. APPLICATOR TAMPONS, O.B. TAMPONS
- K991229 — K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
- K991287 — SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA
- K991314 — COAGULOOP
- K991405 — OMNI-FIX, HUMERAL NAIL
- K991593 — ORIBRUSH - STANDARD - B002
- K991595 — ORIBRUSH - WITH PROTECTIVE TIP - B001
- K991603 — GRIT BLASTED HUMERAL STEM
- K991780 — FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C
- K991781 — FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
- K991952 — OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS
- K992010 — W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED)
- K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE
- K990057 — SYNERGY ADJUSTABLE LENGTH ROD
- K990280 — BIONIKE AQ BARBITURATE TEST
- K990705 — MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET
- K990998 — POLYSLIT IFE KIT
- K991000 — GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES
- K991061 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
- K991234 — THE ACME MEDICAL AESTHETIC ND:YAG LASER
- K991987 — COLOR BUFFED ANSWER CEMENTED FEMORAL
- K983497 — OVERLANDER PEV 2000
- K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
- K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
- K984508 — SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD
- K990122 — INDEPENDENCE 624
- K990484 — INDEPENDENCE 324
- K990771 — 6F HYDROLYSER THROMBECTOMY CATHETER
- K991042 — ASH ADVANTAGE PERITONEAL CATHETER
- K991053 — ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)
- K991081 — FRAMELESS NEUROMATE
- K991168 — ARROW FWD POWER WHEELCHAIR
- K991257 — FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION
- K991325 — MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
- K991366 — DAUM MRI/CONVENTIONAL BIOPSY KIT
- K991444 — HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY).
- K991455 — ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,
- K991587 — BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS
- K991610 — ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
- K991704 — N/T PROTEIN CONTROL LC
- K991759 — MAERSK MEDICAL CONTOUR INFUSION SET
- K991793 — ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
- K991843 — GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE
- K991928 — MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
- K984116 — HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C
- K990020 — TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
- K990325 — QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE
- K990688 — MTM BIOSCANNER C TEST STRIPS
- K991012 — SIEMENS INFINITY EEG POD
- K991035 — QUANTEC-E IRRIGATION SYSTEM
- K991653 — INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
- K991689 — LATEX EXAMINATION GLOVES (POWDER FREE)
- K991690 — LATEX EXAMINATION GLOVES (PRE POWDERED)
- K991775 — MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS
- K991784 — RENEW LEAD EXTENSION
- K991891 — CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15
- K981141 — SARGON IMMEDIATE LOAD IMPLANT, MODEL D
- K982467 — CAPIOX CARDIOPLEGIA
- K984298 — Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI
- K990238 — LONGPORT MODEL LDS -1
- K990876 — BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
- K991004 — SYNTHES QUICK LOCK IMF SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.