FDA 510(k) clearances — page 882
clearances on record, most recent first.
Clearances — page 882
88,101–88,200 of 175,890- K983587 — HYSTEROSCOPIC GIFT CATHETER SETS
- K983605 — IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- K983606 — IS BORRELIA BURGDORFERI IGM TEST SYSTEM
- K983609 — COOK TEST TUBE HEATER
- K983672 — DYNA-LOK SPINAL SYSTEM
- K983807 — LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580
- K983876 — MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC
- K983967 — PEDIATRIC CANNULATED OSTEOTOMY PLATES
- K984044 — QUADRANT POSTERIOR DENSE
- K984185 — MODIFICATION TO TAC-S MONOPOLAR CAUTERY PROBE FAMILY
- K984353 — OSTEO 9MM IC TIBIAL NAIL
- K973718 — ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K981992 — ELECTRON WEDGE MODEL MT-EW-1000
- K983256 — ADVANTAGE WINDOWS (AW) FUSION
- K983392 — DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR
- K983401 — FRAMEWAVE WEB
- K983498 — BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE
- K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS
- K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS
- K983601 — DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
- K983769 — DISTAFLO BYPASS GRAFT
- K984318 — ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05
- K984323 — ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
- K984324 — ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
- K980845 — MS-900S, MS-900SPM & MS-900SFM
- K981643 — RTM DVT PROSOFT CUFF MODEL NUMBER PS100
- K981942 — LATEX POWDER FREE EXAMINATION GLOVES
- K982311 — BARTELS CINAKIT CMV ANTIGENEMIA
- K982612 — ESP7 VENOUS IMAGE
- K982694 — MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES
- K983199 — FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
- K983309 — SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
- K983340 — IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR
- K983489 — ENCORE MARK IV POWDER FREE POLYMER COATED LATEX SURGICAL GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE)
- K983803 — THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K984065 — STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
- K984093 — STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
- K984193 — DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
- K984225 — LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384
- K984372 — ELECSYS CALCHECK TROPONIN T
- K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION
- K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION
- K981253 — ULTRACON ULTRAFILTRATOR
- K981449 — SD-956 ULTRASOUND THERAPY
- K981678 — STRATA, MODEL V.O.95
- K982078 — IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)
- K982323 — OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE
- K982543 — SILVERSTREAK HYDROPHILIC GUIDEWIRE
- K982651 — COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
- K982661 — CDR - PAN MODEL 4700
- K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
- K983227 — POWER BLOCK
- K983242 — SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.