FDA 510(k) clearances — page 881
clearances on record, most recent first.
Clearances — page 881
88,001–88,100 of 175,890- K984464 — LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
- K984470 — LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
- K984473 — LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
- K984475 — LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
- K984476 — LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
- K984478 — LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
- K984479 — LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
- K982535 — INSIGHT DIAGNOSTIC IMAGING WORKSTATION
- K982901 — LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
- K983342 — MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE
- K983413 — MODEL MS-1 HANDPIECE
- K983485 — SYNTHES 1.3 MM SELF-DRILLING SCREW
- K983568 — OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
- K983590 — GIFT CATHETER SET/S
- K983591 — INTRATUBAL TRANSFER SETS
- K983594 — EMBRYO TRANSFER CATHETERS/SETS
- K983640 — SYNCHRON SYSTEMS LIPID CALIBRATOR
- K983731 — PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE
- K983877 — PHILIPS INTEGRIS 3D RA OPTION
- K983909 — MIR SPIROBANK SPIROMETER
- K983974 — OWEN MUMFORD 3ML AUTOPEN
- K980117 — NUVO BARRIER FILM
- K980184 — CD SPINAL SYSTEM
- K980823 — CORDIS NITINOL STENT AND DELIVERY SYSTEM
- K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
- K982712 — RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
- K983031 — VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
- K983297 — MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE
- K983306 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
- K983353 — SCS SPINAL SYSTEM
- K983363 — DCI ENDOSCOPE
- K983365 — AESCULAP MINOP SYSTEM
- K983448 — ML UNIVERSAL TUBING
- K983501 — ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/
- K983536 — PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS
- K983557 — STRYKER WEDGE SUTURE ANCHOR
- K983623 — MODULAP
- K983662 — C.T.M. MOBILITY SCOOTER, MODEL # HS-686
- K983663 — C.T.M. MOBILITY SCOOTER, MODEL # HS-666
- K983733 — SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS
- K983741 — EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020
- K983758 — YASARGIL TITANIUM ANEURYSM CLIPS
- K983766 — SYNTHES SYNMESH
- K983777 — MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
- K983780 — MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
- K983880 — TRANSFERRIN SPQ III ANTIBODY REAGENT SET
- K983906 — DEPUY ORTHOTECH SPIKED WASHER
- K983924 — HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
- K983973 — OPTI-ONE MULTI-PURPOSE SOLUTION
- K984110 — LASERSCOPE COOLSPOT
- K984177 — MODIFICATION TO SKVEKPATCH
- K984245 — NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS
- K984302 — OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
- 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
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