FDA 510(k) clearances — page 883
clearances on record, most recent first.
Clearances — page 883
88,201–88,300 of 175,890- K981737 — K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60
- K983274 — STARTRACK INFANT GRAPHICS MONITOR
- K983303 — INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS
- K983964 — BATCH #6060 CONDUCTIVE GEL
- K984277 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
- K974096 — CRX DIAMOND VALVE
- K974845 — BTA STAT TEST PRESCRIPTION HOME USE
- K982140 — CLINICAL ELECTRONIC THERMOMETER
- K982303 — PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST ST
- K983459 — PULSED OXYGEN CONSERVING DEVICE, POCD
- K983564 — PRODIGY TOTAL BODY SOFTWARE
- K983724 — ORCA-DX BONE DENSITOMETER
- K983804 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K984023 — MAXVIEW DIAGNOSTIC WORKSTATION
- K984105 — ELECSYS TROPONIN T STAT TEST
- K984157 — MODIFICATION TO WILSON-COOK LUNG BIOPSY NEEDLE
- K974064 — MICRO X RESIDUAL TEST STRIPS
- K981054 — BROWNE GA INDICATOR FOR CIDEX PRODUCTS
- K981665 — SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE
- K981746 — CELL ROBOTICS' LASETTE
- K981917 — POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K981972 — GREEN-OR DENTIN DESENSITIZER
- K982391 — REAADS IGG ANTI-B2GPI TEST KIT
- K982433 — REAADS IGM ANTI-B2GP1 TEST KIT
- K982728 — NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C
- K983142 — KSEA C-MOUNT ARTHROSCOPES
- K983146 — ARSOFT
- K983219 — NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900
- K983263 — IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
- K983345 — BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
- K983508 — OSTEO COMPRESSION CONDYLE SCREW SYSTEM
- K983553 — ANTI-TG IGG ELISA TEST SYSTEM
- K983721 — POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE
- K983723 — CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE
- K983725 — OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED, BLUE
- K983759 — ABBOTT ARCHITECT FERRITIN
- K983972 — IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
- K984011 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL RANGE VERIFIERS
- K981781 — ELECTROSURGICAL UNIT
- K981816 — CUE AMBULATORY VOLUMETRIC INFUSION PUMP
- K981912 — HUMAN IGA SUBCLASS BNII COMBI KIT
- K982268 — ULNAR HEAD IMPLANT
- K982275 — RAPPORT V.T.D.
- K982614 — RUSCH POLYFLEX STENT KIT
- K982812 — G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
- K982885 — PRE-POWDERED NON-STERILE SYNTHETIC EXAMINATION GLOVE
- K982995 — ACCUTRAX, MODEL EPF840
- K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
- K983153 — NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS
- K983215 — MULTIPULSE CO2 LASER
- K983226 — OSTEONICS X CEMENTED HIP STEM SERIES
- K983236 — BIPOLAR HF CABLE
- K983397 — STEALTHSTATION TREATMENT GUIDANCE PLAFFORM
- K983641 — HOLLAND FEMORAL NAIL SYSTEM
- K983645 — SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
- K983685 — BONE BAND
- K983757 — SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01
- K983816 — NITRILE LATEX POWDERED EXAMINATION GLOVE
- K983825 — NITRILE LATEX POWDER FREE EXAMINATION GLOVE
- K983881 — COBRA EXTERNAL FIXATOR
- K983917 — THERATRON ELITE
- K983942 — INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP
- K983947 — AMERSE 2
- K984041 — QUADRANT UNIVERSAL LC
- K984042 — QUADRANT CORE LC
- K984043 — QUADRANT TOTAL ETCH
- K972991 — MONITOR ONE NDX
- K982764 — PREMIER CRYPTOSPORIDIUM
- K983116 — ELECTROSURGICAL INFLATABLE BASKET ELECTRODES
- K983128 — IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY
- K983165 — OSTEO 4.0MM CANNULATED SCREW SYSTEM
- K983452 — NELSON RESURFACING HEAD
- K983583 — DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS
- K984071 — LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
- K981171 — ERADIC-ALL
- K981881 — DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING
- K982212 — VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010
- K983026 — PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
- K983279 — ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE
- K983317 — BARRON MICROKERATOME SYSTEM, MODEL B2000
- K983491 — DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
- K983710 — 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH
- K983870 — OSTEONICS RESTORATION HA HIP STEMS
- K971336 — CAIRD TECHNOLOGY SPIROMETER
- K974259 — VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE
- K974617 — PERIPHERAL VASCULAR DILATOR
- K983065 — MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM
- K983072 — AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201
- K983415 — DELIVERY SHEATH
- K983424 — ABBOTT ARCHEITECT TOTAL B-HCG
- K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347
- K983847 — MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT
- K983871 — RITA MODEL 70 ELECTROSURGICAL PROBE
- K984129 — COAGULATION CONTROL LEVEL 1 (NORMAL)
- K984130 — COAGULATION CONTROL LEVEL 2 (ABNORMAL)
- K984131 — COAGULATION CONTROL LEVEL 3 (ABNORMAL)
- K981979 — UNISEAL GLOVES LOW PROTEIN POWDERED
- K982059 — ROTECNO 2000 SURGICAL GOWN
- K982170 — FLUIDSENSE FLUID DELIVERY SYSTEM
- K982218 — NITRILE POWDER-FREE UNISEAL GLOVES
Data sourced from openFDA. This site is unofficial and independent of the FDA.