FDA 510(k) clearances — page 898
clearances on record, most recent first.
Clearances — page 898
89,701–89,800 of 175,890- K981475 — OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE
- K981899 — CARESIDE HDL-CHOLESTEROL
- K982028 — FLUOROSPOT COMPACT
- K982049 — BIOPSY M
- K982203 — CAAS II LVA BIPLANE OPTION
- K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- K972401 — HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
- K980040 — ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D
- K980771 — LYSONIX SUCTION LIPOPLASTY SYSTEM
- K980787 — HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR
- K981351 — CANDELA GENTLELASE GL DERMATOLOGICAL LASER
- K981352 — VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402
- K981358 — ARTOSCAN S
- K981361 — POWERSTAR BIPOLAR SCISSORS
- K981487 — DEPUY GLOBAL SHOULDER GLENOID
- K981531 — SUTURE PLACEMENT DEVICE AND ACCESSORIES
- K981582 — SURGILON, DERMALON, & OPHTHALON
- K981688 — ANSPACH SUTURE ANCHOR
- K981755 — LM ANCHOR
- K981764 — LM ANCHOR
- K981789 — LORENZ PECTUS SUPPORT BAR STABILIZER
- K981798 — LACTOSORB POP RIVET
- K982067 — MAGNETIC PORT SILICONE TISSUE EXPANDER
- K982154 — MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
- K982293 — PRESSURE TRANSDUCER AIRFLOW SENSOR
- K971971 — BROWNE TST SINGLE USE BOWIE-DICK TYPE TEST PACK
- K973161 — CPAP HUMIDIFIER (HC 200)
- K974415 — KIMBERLY-CLARK GAS PLASMA STERILIZATION INDICATOR STRIP
- K974652 — BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
- K974748 — NEUROMETRIC ANALYSIS SYSTEM
- K974763 — DEROYAL INDUSTRIES DISPOSABLE SURGICAL TROCAR/CANNULA
- K981326 — LAKE REGION MANUFACTURING GUIDEWIRES
- K981346 — RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM
- K981393 — MICROCOOL SURGICAL GOWN
- K981441 — HEART CATH TRAY, STERILE, DISPOSABLE
- K981464 — OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
- K981509 — TEMPO III
- K981524 — PRILANE
- K981698 — ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
- K981813 — PERMACEM AUTOMIX LUTING CEMENT SYSTEM
- K981818 — CONVERTORS TRILAMINATE DRAPES
- K981965 — FLOWABLE COMPOSITE
- K972750 — TAKA ANEURYSM CLIP
- K974655 — PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM
- K974801 — SINGLE CHANNEL BALLOON CANNULA
- K980212 — MITYVAC
- K980538 — LASER LANCET LB100
- K980822 — TITANIUM PEG SYSTEM
- K980849 — SURGIN KIT
- K981310 — MAGNATEK C-300
- K981313 — SEQUENCER
- K981315 — NAVITRACK
- K981350 — ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES
- K981469 — CERMAX300 LIGHTSOURCE
- K981527 — MENTOR PATHWAY INTRODUCER/DILATOR
- K981529 — TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
- K981557 — MYCYCLE, HANDMASTER, VICTORY
- K981558 — MYCYCLE HANDMASTER, LIGHT
- K981571 — MONARCH IOL DELIVERY SYSTEM
- K981579 — ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
- K981706 — AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2
- K981835 — SILIMED MALAR IMPLANT
- K981837 — TRX-CG CENTER-OF-GRAVITY SHIFTING POWER TILT AND RECLINE SYSTEMS
- K981850 — SILIMED CHIN IMPLANTS
- K981851 — SILIMED SILICONE CARVING BLOCK
- K981956 — DEGANIA SILICONE IDENTI LOOPS
- K982032 — OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
- K982210 — MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
- K982224 — VIGIL PROTEIN CONTROL
- K974698 — SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS
- K980501 — SKINTONER SYSTEM
- K981294 — ODYSSEY INSTRUMENTATION SYSTEM
- K981301 — SPEED-CUT AUTOMATIC BIOPSY SYSTEM
- K981483 — EBI DFS JOINT FIXATOR, MODEL 02800
- K981612 — ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER
- K981615 — KSEA UROPUMP
- K972255 — PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM
- K972328 — PERCUTANEOUS BREAST BIOPSY (PBB)
- K972899 — CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER
- K974799 — HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
- K980177 — SUGITRON MODEL: IEC
- K980487 — CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM
- K981321 — BIPOLAR FORCEPS SET (MODULAR)
- K981322 — CUTALON NYLON POLYAMIDE SURGICAL SUTURE
- K981428 — ANU ICE
- K981479 — IL TEST PT-FIBRINOGEN RECOMBINANT
- K981488 — GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION
- K981559 — UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY
- K981592 — ACS:CENTAUR AFP
- K981828 — GALILEO DISPOSABLE HYSTEROSCOPES
- K981883 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
- K981930 — UNICAP THYROID PEROXIDASE IGG
- K971252 — SEVRAIN CRANIAL CLAMP
- K974025 — ANSPACH SHIELDED ATTACHMENT
- K974715 — ADVANTAGE 3D XR
- K974837 — IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS
- K980638 — ADI SYPHILIS RPR LIQUID CONTROLS
- K980775 — COMPLETE BRAND MULTI-PURPOSE SOLUTION
- K980877 — ETEST CEFDINIR
- K981262 — CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.