FDA 510(k) clearances — page 830
clearances on record, most recent first.
Clearances — page 830
82,901–83,000 of 175,890- K000779 — APEXPRO TELEMETRY SYSTEM
- K000784 — THE CARDIAC READER SYSTEM
- K000903 — ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
- K000921 — BAYER ADVIA IMS SYSTEM; 200 + 3
- K001086 — FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
- K001098 — PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
- K001237 — EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
- K001257 — INTRACOIL STENT
- K001335 — ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
- K001451 — MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
- K992320 — MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
- K992543 — HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE
- K993438 — METAL ON METAL ACETABULAR SYSTEM
- K994225 — PALOMAR SLP 2000
- K000121 — IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
- K000155 — ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
- K000405 — INTERCURE LTD. RESPI-LOW
- K000530 — BELLEGLASS HP ENAMEL
- K000556 — ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS
- K000563 — MODIFICATION TO ENVOY PATIENT MONITOR
- K000597 — VITA RESPONSE
- K000618 — SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
- K000690 — 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
- K000775 — HEART 2005
- K000799 — BELMONT UNIT, MODEL 2000 SERIES
- K000812 — NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)
- K000932 — ARACHNOPHLEBECTOMY NEEDLE
- K001115 — ULTRA CATHETER SET
- K001222 — OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
- K001224 — RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
- K001225 — ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
- K001260 — ALLROUND 55 LF
- K001308 — MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW
- K001333 — AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI
- K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM
- K001348 — ST/AR ST AND ARRHYTHMIA SOFTWARE
- K001381 — CIDEX OPA SOLUTION
- K001431 — MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
- K991348 — IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
- K993278 — AMBU NEONATE SILICONE RESUSCITATOR
- K993592 — AXIOM MULTIPURPOSE WOUND DRAIN
- K000303 — HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB
- K000520 — C-IT
- K000621 — SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
- K000623 — SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
- K000693 — UMECO OPTIMA MULTILINE LASER SYSTEM
- K000770 — PROVIEW MEDICAL IMAGE DISPLAY MODULE
- K001013 — MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
- K001169 — OPTIVU HDVD SYSTEM
- K001220 — ENDOPATH SURESEAL REDUCER CAP
- K001321 — ALL-PRO 2010
- K001438 — SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
- K993337 — APOLLO MULTI-RACIAL REFERENCE POPULATION
- K993699 — THE STRIPPER
- K000078 — JETLITE 4000
- K000179 — NUZONE NITRILE SURGICAL GLOVES POWDER FREE
- K000399 — STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
- K000493 — STRYKER IRRIGATION TUBE SET
- K000503 — MEDART 520 COOLING SYSTEM
- K000510 — ART-M1, MODEL M1-1-ART-A1
- K000607 — SOLO-CARE BRAND HARD SOLUTION
- K000926 — EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
- K000928 — QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K001232 — NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS
- K001239 — ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K001280 — COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES
- K001444 — STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103
- K993732 — BVBLUE
- K993760 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 200 MICROGRAMS OR LESS
- K994334 — ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX
- K000162 — METRISCAN BONE DENSITY SYSTEM
- K000281 — WALLSTENT ENTERNAL PROSTHESIS
- K000485 — HYDRO2, HS-75
- K000630 — MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
- K000819 — PHILIPS CT SECURA MV
- K000905 — URETHROTOME 8667.XXX AND 8670.XXX
- K000915 — PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75
- K000948 — OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
- K000950 — EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 320201
- K001171 — DELTA 16 TACT
- K001198 — DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
- K001208 — ESPIRT
- K001267 — GE SYSTEM FIVE
- K001368 — PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
- K992178 — BALLOON FOR ULTRASONIC ENDOSCOPES
- K992192 — AIRPILOTMASK, MODEL TMS-900
- K992823 — SPIROVIT SP-2, PNEUMOCHECK II
- K000189 — PQ1
- K000590 — LATERAL PIVOT INSERT
- K000636 — STRYKER TRAUMA PLATING SYSTEM
- K000658 — ERS RADIAL HEAD REPLACEMENT
- K000694 — PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
- K000706 — DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
- K000710 — MD 10, SEM, SM 12, CBM
- K000965 — MULTI-AXIAL CROSS (MAC) CONNECTOR
- K001030 — RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
- K001055 — MODEL 4300 PSARRAY EEG ELECTRODE SET
- K001145 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
- K001196 — JEL BIOS 90 (CODE NAME RD-2401)
- K001197 — COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA
Data sourced from openFDA. This site is unofficial and independent of the FDA.