FDA 510(k) clearances — page 873
clearances on record, most recent first.
Clearances — page 873
87,201–87,300 of 175,890- K984434 — MEDIVISION LAPAROSCOPE
- K984521 — RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351
- K984587 — ALLROUND-E (CODE NAME RD 1710)
- K984628 — MODIFICATION OF MOSS P.E.G. TRAY
- K990066 — CCD CAMERA, MODEL 9000
- K990146 — SURGITRON
- K990481 — ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
- K990513 — ULTIMAX CORTICAL BONE SCREWS
- K980688 — INTEGRITI PATIENT MONITOR
- K984216 — IMMUNO-TROL CONTROL CELLS
- K984466 — DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
- K984582 — ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX
- K990009 — CARESIDE AST
- K990293 — ALADDIN II MONITORING OXYGEN/AIR MONITOR
- K980840 — LOKKI DT
- K981955 — MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS
- K983119 — ENTERO-TEST HP, MODEL #102-01
- K983202 — HARWILL MEDICAL CERVITULA CERVICAL SPATULA
- K983228 — BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000
- K983295 — BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520
- K983385 — HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS
- K983742 — ITI DENTAL IMPLANT SYSTEM
- K983835 — IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA
- K983882 — MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400
- K984018 — HEMOSLEEVE, MODEL 4.0MM, 5.5MM
- K984190 — BACK-ON-TRAC, MODEL 101BOT
- K984427 — EXCELSIOR PORCELAIN SYSTEM
- K984492 — TIGRAN HIP PROSTHESIS
- K984534 — PRECLUDE ACUSEAL DURA SUBSTITUTE
- K984583 — THE BIOPLATE SHUNT CONNECTOR
- K990019 — DRG MEDIUM SCREW SYSTEM
- K990089 — SILKAM NONABSORBABLE SILK SURGICAL SUTURE
- K990152 — OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER
- K990309 — PLUS FRACTURE HEAD PROSTHESIS
- K990391 — ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01
- K990423 — PHILIPS NICOL COLLIMATOR FAMILY
- K990463 — MEDLINE EXCEL WHEELCHAIRS
- K990598 — OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD
- K990606 — TETRAFILCON A
- K990765 — FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO
- K990805 — MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER
- K980964 — MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS
- K982466 — IMMULITE THYROGLOBULIN MODEL LKTY
- K982468 — IMMULITE 2000 THYROGLOBULIN MODEL L2KTY
- K982600 — PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
- K982739 — GYNEX ELECTRODES
- K983355 — SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR
- K983843 — BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B
- K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
- K984289 — VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
- K984518 — SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
- K984580 — BIOSACA SYSTEM
- K984634 — 3D-ANGIO
- K990049 — CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000
- K990192 — BIOPSY-DIGIT
- K990369 — SYNERGY CEMENTED HIP STEM
- K990430 — ULTRACISION HARMONIC SCALPEL HAND PIECE
- K990531 — VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS
- K982173 — BUZBEE
- K982992 — ZOLL M SERIES SPO2 OPTION
- K983171 — CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM
- K983927 — GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
- K984418 — UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
- K990240 — ELECTROGLOTTOGRAPH
- K990506 — MABIS NB-02 ULTRASONIC NEBULIZER
- K990573 — ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA
- K981996 — TITANIUM FEMORAL COMPONENT
- K990603 — MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM
- K981446 — WAKO AUTOKIT LP(A)
- K982283 — WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH
- K983379 — GTI-PF4 ELISA
- K984271 — MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0
- K984491 — SYSTEM U3 FOR CEFUROXIME
- K984581 — SYSTEM U3 FOR CEPHALOTHIN
- K984608 — GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K990108 — LC FLOWFILL
- K990282 — ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01
- K990283 — BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
- K990375 — DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
- K990453 — NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR
- K990514 — MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR
- K990576 — OSOM CARD PREGNANCY TEST, MODEL 103
- K990578 — OSOM CARD II HCG-URINE TEST, MODEL 102
- K983105 — CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01
- K983126 — FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
- K984394 — ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
- K990035 — RF
- K990498 — OPTIBOND SOLO PLUS
- K980351 — BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
- K981702 — AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300
- K982952 — IMFAST
- K983164 — RESTORE (AKA RE/STOR)
- K983194 — SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)
- K984382 — ACCU GUIDE
- K984424 — AURA DYE LASER SYSTEM (ADLS)
- K984443 — ORBSCAN
- K984552 — COOL-TIP RF SYSTEM
- K984602 — SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM
- K984607 — PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX
- K984623 — MAXIM REMOVABLE MOLDED POLY TIBIA
Data sourced from openFDA. This site is unofficial and independent of the FDA.