FDA 510(k) clearances — page 889
clearances on record, most recent first.
Clearances — page 889
88,801–88,900 of 176,637- K984383 — ULTRACARE NEUTRALIZING TABLETS
- K984396 — LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213
- K984397 — LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203
- K984398 — LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
- K984399 — LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
- K984400 — LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
- K982426 — SPIFE ALKALINE HEMOGLOBIN
- K982981 — NEW ZIMMER SHOULDER SYSTEM
- K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA
- K983305 — SCI-PHARM DESENSITIZING VARNISH
- K983310 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
- K983403 — SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
- K983432 — SUPREME II CONTROL SOLUTIONS
- K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-01
- K983473 — FERTILMARQ TEST KIT
- K983789 — CARESIDE CALCIUM, ORIGINAL
- K983954 — ALASTAT MICROPLATE MIXED ALLERGEN PANELS
- K984175 — THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
- K984218 — OASIS
- K984268 — VARIANT II HEMOGLOBIN A1C PROGRAM
- K984286 — HEARTSTREAM ELECTRODE ADAPTER
- K984315 — THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE
- K984325 — ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05
- K984347 — THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
- K970736 — BRAUN PREFILLED SYRINGE
- K980475 — UNIPULSE CO2 SURGICAL LASER SYSTEM
- K980637 — IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT
- K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION
- K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
- K982316 — LASEAWAY ALEXANDRITE LASER SYSTEM
- K982650 — AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
- K982804 — SPYROGEL HYDROGEL WOUND AND BURN DRESSING
- K983073 — I.V. EXTENSION SET OR I.V. ADMINISTRATION SET
- K983163 — BIATAIN FOAM DRESSING
- K983169 — POLYMER THREADED ANCHOR
- K983173 — BIATAIN FOAM ADHESIVE DRESSING
- K983277 — LIGHTSOURCE OR ILLUMINATOR MODEL I-100
- K983293 — AUTO SUTURE LAPAROSCOPES DEVICE
- K983331 — MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102
- K983362 — NU-GEL * WOUND DRESSING
- K983414 — EVERBOND
- K983454 — PAIN CARE 2000
- K983495 — SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420
- K983502 — OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM
- K983530 — SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
- K983543 — ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM
- K983561 — FUJINON EVL-F VIDEO LAPROSCOPE
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.