FDA 510(k) clearances — page 854

176,637 clearances on record, most recent first.

Clearances — page 854

85,301–85,400 of 176,637

K993602 — PRE-VISION FILLHeraeus Kulzer, Inc.·Product code EBF·1999-12-15
K993628 — OMNISONICS ULTRASONIC PROBESOmnisonics Medical Technologies·Product code LFL·1999-12-15
K993689 — AED CYSTOSCOPENational Advanced Endoscopy Devices, Inc.·Product code FAJ·1999-12-15
K993855 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEMDanek Medical, Inc.·Product code KWQ·1999-12-15
K993276 — SIMPLIFY D-DIMER, MODEL DCGK1Agen Biomedical , Ltd.·Product code GHH·1999-12-14
K993421 — BACT/ALERT SNOrganon Teknika Corp.·Product code MDB·1999-12-14
K993576 — BACT/ALERT MP PROCESS BOTTLEOrganon Teknika Corp.·Product code MDB·1999-12-14
K993886 — EBI XFIX VISION FIXATION SYSTEMEbi, L.P.·Product code KTT·1999-12-14
K993308 — MENTOR EVACARE VAGINAL PESSARIESMentor Corp.·Product code HHW·1999-12-13
K993572 — CERADIUM V NON-PRECIOUS CERAMIC ALLOYMatech, Inc.·Product code EJH·1999-12-13
K993680 — SYNTHETIC VINYL MEDICAL EXAMINATION POWDER FREE GLOVETop Glove Sdn. Bhd.·Product code LYZ·1999-12-13
K993683 — PULPDENT UNO-DUOPulpdent Corp.·Product code KLE·1999-12-13
K993783 — TETRIC FLOWIvoclar North America, Inc.·Product code EBF·1999-12-13
K983250 — INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITORMagnetic Resonance Equipment Corp.·Product code DSK·1999-12-12
K983637 — ACTIFRESH 400 LENSHydron , Ltd.·Product code LPL·1999-12-10
K990308 — ROCAP HEPARIN IV FLUSH SYRINGE, 100U/MLRocap Div. of Sabratek Corp.·Product code FOZ·1999-12-10
K990390 — HEPARIN IV FLUSH SYRINGE, 10 U/ML \Rocap Div. of Sabratek Corp.·Product code FOZ·1999-12-10
K991465 — DRUG STOPTexas Immunology, Inc.·Product code MVO·1999-12-10
K991714 — DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00Doctor'S Research Group, Inc.·Product code DQD·1999-12-10
K991756 — 3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPEBio-Research Associates, Inc.·Product code DQD·1999-12-10
K991878 — LUMA-CATH STEERABLE EP CATHETERSIrvine Biomedical, Inc.·Product code DRF·1999-12-10
K992209 — CUSTODIOLDr. Franz Kohler Chemie GmbH·Product code KDN·1999-12-10
K992943 — VIT ENHANCERMedical Instrument Development Laboratories, Inc.·Product code HQE·1999-12-10
K993062 — CHEST DRAINAGE TUBINGOlson Medical Sales, Inc.·Product code DWE·1999-12-10
K993072 — SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)Survivalink Corp.·Product code MKJ·1999-12-10
K993074 — SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd.·Product code MAI·1999-12-10
K993103 — ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREESRichard Wolf Medical Instruments Corp.·Product code GCM·1999-12-10
K993226 — MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006Memcath Technologies, LLC·Product code EZD·1999-12-10
K993339 — ENDOPEARL WITH THREADERLinvatec Corp.·Product code MAI·1999-12-10
K993464 — BARDEX I.C. PEDIATRIC FOLEY CATHETERC.R. Bard, Inc.·Product code MJC·1999-12-10
K993799 — CG-7000DX ECG RECORDER/TRANSMITTERCard Guard Scientific Survival , Ltd.·Product code DXH·1999-12-10
K993822 — EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEMEbi, L.P.·Product code KWQ·1999-12-10
K993833 — AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITSAllegiance Healthcare Corp.·Product code BZE·1999-12-10
K993914 — PREMIER TOXINS A&B, MODEL 616096Meridian Diagnostics, Inc.·Product code LLH·1999-12-10
K983746 — MICROSTREP PLUS PANELDade Microscan, Inc.·Product code JWY·1999-12-09
K983907 — RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-RWoodside Biomedical, Inc.·Product code GZJ·1999-12-09
K990503 — SULZER VASCUTEK GELSOFT VASCULAR PROSTHESISSulzermedica·Product code DSY·1999-12-09
K992298 — IRIDERM, MODEL APEX 800Iridex Corp·Product code GEX·1999-12-09
K992368 — LEMAITRE EMBOLECTOMY CATHETERVascutech, Inc.·Product code DXE·1999-12-09
K992581 — ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, SPINE WANDS, ORTHOWANDS, ARTHROWANDSArthrocare Corp.·Product code GEI·1999-12-09
K992939 — QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3Seracare Technology·Product code JJY·1999-12-09
K992995 — AROMATIC AND FLAVORED TONGUE DEPRESSORAga Plastic Ind. Com. Ltda.·Product code FMA·1999-12-09
K993054 — ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141Ethicon Endo-Surgery, Inc.·Product code LFL·1999-12-09
K993063 — RUSCH BRILLANT SILICONE FOLEYRusch Intl.·Product code EZL·1999-12-09
K993095 — FRIALIT-2 SELECT COMPONENTSFriadent GmbH·Product code DZE·1999-12-09
K993106 — SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES)Smith & Nephew, Inc.·Product code HRS·1999-12-09
K993112 — XOMED ENT RF SYSTEMXomed, Inc.·Product code GEI·1999-12-09
K993475 — AUROFLUID M, ALLOY NO. 5315Metalor Dental USA Corp.·Product code EJS·1999-12-09
K993631 — QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2Seracare Technology·Product code JJY·1999-12-09
K993821 — VECTORSURGE 4 INTERFERENTIAL THERAPY UNITMetron Medical Australia, Pty, Ltd.·Product code IPF·1999-12-09
K993829 — ACCU-CHEK SIMPLICITY SYSTEMRoche Diagnostics Corp.·Product code LFR·1999-12-09
K991882 — NEXFLEX TOTAL KNEE SYSTEMNexmed, Inc.·Product code JWH·1999-12-08
K992595 — HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITHHewlett-Packard GmbH·Product code MHX·1999-12-08
K993505 — V-DELTA SPECIAL, ALLOY NO. 5154Metalor Dental USA Corp.·Product code EJS·1999-12-08
K993506 — PAGALINOR 4 , ALLOY NO. 5440Metalor Dental USA Corp.·Product code EJS·1999-12-08
K993766 — HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEMHelax AB·Product code MUJ·1999-12-08
K984168 — BARRETT'S ESOPHAGEAL CYTOLOGY DEVICEUnited States Endoscopy Group, Inc.·Product code FCF·1999-12-07
K990329 — PHILIPS EASYVISION WORKSTATIONPhilips Medical Systems North America, Inc.·Product code LNH·1999-12-07
K990643 — PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015Althin Medical AB an Affiliate of Baxter Intl·Product code KDI·1999-12-07
K991706 — VIRTUOSO-STEREOTAXIC PLANNING SOFTWAREStryker Corp.·Product code HAW·1999-12-07
K993299 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500Dade Behring, Inc.·Product code GKP·1999-12-07
K993774 — ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOHAcist Medical Systems·Product code DXT·1999-12-07
K993945 — BIONIKE AQ PHENCYCLIDINE (PCP) TESTBionike Laboratories, Inc.·Product code LCM·1999-12-07
K984088 — OPTISTAR MR INJECTOR SYSTEMMallinckrodt Inc., Liebel-Flarsheim Business·Product code DXT·1999-12-06
K990110 — DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140Maersk Medical A/S·Product code DRX·1999-12-06
K990111 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570Maersk Medical A/S·Product code DRX·1999-12-06
K990112 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610Maersk Medical A/S·Product code DRX·1999-12-06
K990113 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560Maersk Medical A/S·Product code DRX·1999-12-06
K990115 — DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440Maersk Medical A/S·Product code DRX·1999-12-06
K991339 — TYRODE'S SOLUTION-ACIDIFIEDIrvine Scientific Sales Co., Inc.·Product code MQL·1999-12-06
K992188 — NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028Nichols Institute Diagnostics·Product code JNM·1999-12-06
K992711 — SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094Sigma Diagnostics, Inc.·Product code GFO·1999-12-06
K992712 — SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334Sigma Diagnostics, Inc.·Product code GFO·1999-12-06
K992759 — COLON ALERT TESTImmunostics Inc.,·Product code KHE·1999-12-06
K993008 — QUANTITATIVE SENTINEL SYSTEMMarquette Medical Systems, Inc.·Product code HGM·1999-12-06
K993073 — SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030Bionx Implants, Ltd.·Product code MAI·1999-12-06
K993255 — BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTEColtene/Whaledent, Inc.·Product code FRG·1999-12-06
K993304 — AUTOSTAT II RHEUMATOID FACTOR IGG ELISACogent Diagnotics , Ltd.·Product code DHR·1999-12-06
K993309 — BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAYBayer Corp.·Product code MMI·1999-12-06
K993314 — SYNTHES LIGHT GUIDESynthes (Usa)·Product code FQP·1999-12-06
K993353 — TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)Bayer Corp.·Product code MMI·1999-12-06
K993435 — MANUAL BONE MARROW BIOPSY DEVICEPromex, Inc.·Product code KNW·1999-12-06
K993445 — OMNISONIC ENDOSCOPIC DEFLECTOROmnisonics Medical Technologies·Product code GCM·1999-12-06
K993482 — K-ASSAY FIBRINOGENKamiya Biomedical Co.·Product code GIS·1999-12-06
K993507 — V-SUPRAGOLD, ALLOY NO. 5024Metalor Dental USA Corp.·Product code EJT·1999-12-06
K993508 — V-SUPRA PLUS, ALLOY NO. 5025Metalor Dental USA Corp.·Product code EJT·1999-12-06
K993566 — PROMPTFLOWEspe Dental AG·Product code EBF·1999-12-06
K993688 — AED LAPAROSCOPENational Advanced Endoscopy Devices, Inc.·Product code GCJ·1999-12-06
K993808 — SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220Interpore Cross Intl.·Product code MNH·1999-12-06
K993854 — ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIESOratec Interventions, Inc.·Product code GEI·1999-12-06
K993907 — VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22Agilent Technologies, Inc.·Product code MHD·1999-12-06
K981655 — SPACELABS MEDICAL DISPOSABLE SP02 SENSORSpacelabs Medical, Inc.·Product code DQA·1999-12-03
K990807 — HL148 & HL168Health & Life Co., Ltd.·Product code DXN·1999-12-03
K991575 — PRIMUS STEAM STERILIZERSPrimus Sterilizer Co., Inc.·Product code FLE·1999-12-03
K992992 — AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050AToshiba America Medical Systems, In.C·Product code KPS·1999-12-03
K993001 — COBE SMARXT HVR 4000 SURFACE MODIFIED HARDSHELL VENOUS RESERVOIR, FILTERED & NONFILTEREDCobe Cardiovascular, Inc.·Product code DTN·1999-12-03
K993454 — POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)Sri Johani Sdn. Bhd.·Product code LYY·1999-12-03
K993708 — BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEGBiomagnetic Technologies, Inc.·Product code OLX·1999-12-03
K993729 — MODIFICATION TO CARTO EP NAVIGATION SYSTEMBiosense Webster, Inc.·Product code DQK·1999-12-03
K993749 — GYRUS HYSTEROSCOPIC RESECTOSCOPEGyrus Medical , Ltd.·Product code HIH·1999-12-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.