FDA 510(k) clearances — page 888
clearances on record, most recent first.
Clearances — page 888
88,701–88,800 of 176,637- K984535 — PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
- K983559 — BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
- K983811 — UNIPOLAR OPTICAL BIOPSY FORCEPS
- K982832 — PROGUARD, RR-1, RR-2
- K982897 — POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K983366 — TRIP TONOMETRY CATHETER, 16F
- K983374 — AGATHA-A-H2010
- K983486 — SYSTEM U3 FOR NORFLOXACIN
- K983514 — POSITRON OPTION, MODEL NSCO-050A
- K983516 — TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A
- K983528 — MICRO DYNAMIC MESH
- K983714 — SOLARTEC SOURCE 270, MODEL # 90123
- K983716 — VITALCARE DISPOSABLE VAGINAL SPECULUM
- K984014 — SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
- K984019 — POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS)
- K984020 — POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
- K984145 — OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
- K984211 — MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303
- K984359 — AIA-PACK TROPONIN I ASSAY
- K984384 — 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
- K984500 — CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
- K970829 — PHUSIS ABSORBABLE INTERFERENCE SCREW
- K971981 — LS SERIES 200 FLOVISION SYSTEM
- K972788 — CROSSLAPS ELISA
- K972975 — LIGHT DIAGNOSTICS RABIES DFA REAGENT
- K980675 — SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
- K981363 — ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST
- K981554 — MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
- K981824 — OPTICOAT T3 EIA KIT
- K982091 — CS/3 COMPACT AIRWAY MODULE, M-COVX
- K982344 — DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS
- K982434 — REAADS IGA ANTI-B2GP 1 TEST KIT
- K983404 — TYPE 3 FEMORAL COMPONENTS
- K983470 — SUPER PORCELAIN STAIN- PURE WHITE
- K983477 — SUPER SEAL
- K983653 — RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D
- K983773 — BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
- K983853 — DEPUY ACE TIMAX META PLATE
- K983899 — THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
- K983904 — ROGOZINSKI SPINAL ROD SYSTEM
- K983914 — REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
- K983965 — CO2 LASER COUPLER
- K984112 — ADVENT
- K984173 — THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
- K984319 — ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05
- K984327 — ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05
- K984462 — LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.