FDA 510(k) clearances — page 890
clearances on record, most recent first.
Clearances — page 890
88,901–89,000 of 176,637- K983313 — ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
- K983320 — ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
- K983348 — DYNAREX TRACHEOSTOMY SPONGE
- K983350 — ILO292 DP ECHOPORT PLUS OAE SYSTEM
- K983351 — ILO292 DP ECHOPORT PLUS OAE SYSTEM
- K983352 — ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
- K983382 — OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
- K983463 — SURECAUT DIAMOND LASER KNIFE
- K983526 — VERTICAL LIFT
- K983599 — SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
- K983628 — XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
- K983630 — SEARE BIOMEDICAL SILICONE RODS
- K983649 — MAX-ACT
- K983697 — MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
- K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
- K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
- K983701 — MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
- K983703 — MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
- K983718 — MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K983729 — POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
- K983730 — OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, BLUE
- K983765 — INJECTION NEEDLE PROBE/DEVICE-TUNIS
- K983792 — SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
- K983821 — PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE
- K984111 — FV-RF
- K984196 — MODIFICATION TO PROWESS PRO-SIM
- K984272 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
- K984278 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
- K984299 — AVL OPTI CRITICAL CARE ANALYZER
- K973328 — INTERSOURCE
- K980973 — MEDTRONIC ANGIOGRAPHIC CATHETER
- K981922 — LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI
- K981946 — CLEARVIEW IM
- K982076 — AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM
- K983182 — ALOE THERAPY ORAL RINSE
- K983183 — GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P
- K983187 — MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE
- K983210 — ALGISITE M
- K983412 — MEDCOMP H-CATH TRIPLE LUMEN CENTRAL VENOUS ACCESS CATHETER, MODEL SIC 12-3T
- K983525 — GORE REVOX THYROPLASTY IMPLANT
- K983752 — ALUMINA-ZINC OXIDE POWDERS F AND R
- K983801 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
- K983833 — ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE
- K984099 — QBC CENTRIFUGAL HEMATOLOGY CONTROL
- K984191 — MYOGLOBIN FLEX REAGENT CARTRIDGE
- K984379 — NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
- K980378 — MELODIE INFUSION PUMP
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.