FDA 510(k) clearances — page 829
clearances on record, most recent first.
Clearances — page 829
82,801–82,900 of 175,890- K001108 — PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
- K001264 — EAGLE ENDO SPECIMEN RETRIEVAL BAG
- K001302 — ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C
- K001330 — SOVEREIGN BIPOLAR INSTRUMENTS
- K993010 — BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
- K993991 — HM-930 ELECTROSURGICAL UNIT
- K000215 — SWIVEL ELBOW
- K000500 — DINAMAP ADVANCED NIBP MODULE
- K000669 — MEDIVISION I-VIEW PERSONAL VIDEO DISPLAY
- K000673 — HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
- K000738 — WHEELCHAIR, MODELS H001A, 4422
- K000795 — RIGID GAS PERMEABLE CONTACT LENS
- K000802 — SPIRAL IMAGING OPTION
- K000960 — BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900
- K000973 — BEHRING COAGULATION SYSTEM (BCS)
- K000993 — LIBERTY 9000 BREAST COIL
- K001203 — OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT
- K001253 — SURGITRON IEC II
- K001315 — MODIFICATION TO KION ANESTHESIA SYSTEM
- K001397 — QUICKSCREEN PRO DRUG CUP, MODEL 9195X
- K001428 — OPTIMUM WETTING AND REWETTING DROP
- K001429 — MODIFICATION TO ACCUDEXA BONE DENSITOMETER
- K992668 — INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
- K994260 — CANDELA GENTLELASE GL DERMATOLOGICAL LASER
- K994329 — IIVS INTEGRATED IMAGE VIEWING STATION
- K000633 — SYNTHETIC GLASS BONE GRAFT MATERIAL
- K000639 — VISIONARY 2000
- K000680 — VISION ESTHETIC PORCELAIN SYSTEM
- K000686 — KROM-ALGINATE AND ALGINATE PLUS
- K000937 — IVC TWO MEDIUM
- K000938 — IVC ONE MEDIUM
- K001373 — LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
- K992085 — ABBOTT IMX GLYCATED HEMOGLOBIN II
- K993484 — Q-HTF, CAT# 2001
- K993777 — DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODES
- K993877 — NELSON WATER SYSTEMS FOR HEMODIALYSIS
- K000645 — GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
- K000922 — PROTON VISION
- K000958 — ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
- K001002 — WAKO LIPASE CALIBRATOR
- K001243 — DORNIER MEDILAS H
- K001256 — CONTROL PLASMA N
- K001346 — ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
- K991894 — BIOSCANNER TRIGLYCERIDES TEST STRIPS
- K993355 — HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43
- K000108 — RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
- K000178 — NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
- K000604 — NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT
- K000609 — CARDTEL, MODEL NT-100
- K000625 — SCANDINAVIAN IVF SCIENCES AB, G1.2
- K000626 — SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
- K000760 — REACH FEMORAL COMPONENT
- K000957 — HOFFMANN II EXTERNAL FIXATION SYSTEM
- K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX
- K001024 — PASS SPINAL SYSTEM
- K001029 — GEIGER NEEDLE ADAPTER, MODEL 406
- K001035 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
- K001041 — AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD
- K001042 — COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATE
- K001049 — GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)
- K001065 — DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
- K001122 — PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
- K001128 — NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
- K001155 — DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
- K001190 — POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE
- K001307 — CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
- K001319 — XIA SPINE SYSTEM HOOKS
- K001327 — POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)
- K001358 — EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM
- K990614 — HME-BOOSTER
- K993921 — NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001
- K994098 — VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
- K994350 — NEER III TOTAL SHOULDER SYSTEM
- K994426 — GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)
- K000596 — ETEST GATIFLOXACIN
- K000879 — THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K000880 — THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K000930 — GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K000999 — MULTISAFE POWDER-FREE PATIENT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K993131 — NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
- K993319 — VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
- K993586 — SPORTSIGHT GP
- K000133 — MENICON Z
- K000233 — MENICON SF-P
- K000308 — WALLSTENT BILIARY ENDOPROSTHESIS
- K000637 — CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
- K000704 — DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
- K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)
- K000729 — ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
- K000849 — SOFTFORM FACIAL IMPLANT
- K000894 — C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO
- K001043 — KAWASUMI LABORATORY BLOOD DRAWING KIT
- K001089 — POLYMACON
- K001090 — METHAFILCON A
- K001119 — ROVERS ENDOCERVEX-BRUSH
- K001221 — MALE LATEX COMDOM WITH DOTTED SURFACE
- K993758 — PROAIR 3000 COMPRESSION SYSTEM
- K994188 — MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
- K000298 — ETEST MOXIFLOXACIN
- K000611 — STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.