FDA 510(k) clearances — page 935

176,637 clearances on record, most recent first.

Clearances — page 935

93,401–93,500 of 176,637

K972204 — ACU-RAY HF SERIES PORTABLE X-RAY UNITSterne Equipment Co., Ltd.·Product code IZL·1997-10-08
K972569 — E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATIONNsk Nakanishi, Inc.·Product code EGS·1997-10-08
K972612 — DISSECTRON PORTABLE UNITSatelec·Product code LBK·1997-10-08
K972654 — MANIFOLDMedical Specialties Intl., Inc.·Product code DTL·1997-10-08
K972726 — SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEMMedical Packaging Corp.·Product code JSM·1997-10-08
K972778 — DEY VIAL SODIUM CHLORIDE 3%Dey Laboratories, Inc.·Product code CAF·1997-10-08
K972815 — PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENTGrace Medical, Inc.·Product code ETB·1997-10-08
K972922 — VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703KInterview Medical Technology Corp.·Product code EMX·1997-10-08
K972926 — MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPEKARL STORZ Endoscopy-America, Inc.·Product code FBN·1997-10-08
K972968 — ROTOGRAPH PLUSChicago X-Ray Systems, Inc.·Product code EHD·1997-10-08
K972986 — ACCURUN 140 RUBELLA IGG POSITIVE CONTROLBoston Biomedica, Inc.·Product code MJX·1997-10-08
K973073 — DRTS IMAGE INTENSIFIER DRAPEMinrad, Inc.·Product code JAA·1997-10-08
K973125 — MAMMOLOADER BY C.M.A. SRLC.M.A.·Product code IXW·1997-10-08
K973219 — AMBER DUOldelft Corp. of America·Product code KPR·1997-10-08
K973327 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800THShimadzu Medical Systems·Product code JAK·1997-10-08
K973329 — SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXShimadzu Medical Systems·Product code JAK·1997-10-08
K973342 — DAR-3000BShimadzu Corp.·Product code IZI·1997-10-08
K973589 — LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,·Product code CFJ·1997-10-08
K971590 — TACTYLON CONDOMSensicon Corp.·Product code MOL·1997-10-07
K971643 — RUSCH BRILLANT BALLOON CATHETERRusch Intl.·Product code EZL·1997-10-07
K972558 — BIPOLAR SCISSORSEnable Medical Corp.·Product code GEI·1997-10-07
K972678 — MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETSMcgaw, Inc.·Product code FRN·1997-10-07
K972825 — OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDABCordis Corp.·Product code FGE·1997-10-07
K972847 — KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)Eastman Kodak Company·Product code LMC·1997-10-07
K973086 — PLA-96PSouthern Dental Industries, Inc.·Product code EJJ·1997-10-07
K973245 — TOKUSO REBASE MR. BONDTokuyama America, Inc.·Product code KLE·1997-10-07
K973629 — PRECINORM RF, PRECIPATH RFBoehringer Mannheim Corp.·Product code JJY·1997-10-07
K972342 — REAADS PROTEIN C ANTIGEN TEST KITReaads Medical Products, Inc.·Product code GGP·1997-10-06
K972561 — NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGYAmerican Laser Medical·Product code GEX·1997-10-06
K972811 — HOWMEDICA FULLY THREADED SCREWSHowmedica Corp.·Product code HSB·1997-10-06
K972974 — ACCUWELL T4-EIANeometrics, Inc.·Product code KLI·1997-10-06
K973074 — 2487 DUAL WAVELENGTH ABSORBANCE DETECTORWaters Corporation·Product code KZR·1997-10-06
K973126 — TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-IBiosite Incorporated·Product code JHX·1997-10-06
K973358 — MYOGLOBIN CONTROL SETBoehringer Mannheim Corp.·Product code JJX·1997-10-06
K973367 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEMRadiometer America, Inc.·Product code CHL·1997-10-06
K973487 — CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1997-10-06
K964617 — GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEMGE Medical Systems·Product code IYO·1997-10-03
K965226 — EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARELunar Corp.·Product code KPS·1997-10-03
K970456 — HEWLETT APCKARD SERIES 50 OB TRACEVUE OBSTETRICAL SURVEILLANCE AND ARCHIVING SYSTEMHewlett-Packard GmbH·Product code HGM·1997-10-03
K970570 — NIVP3 (WINDOWS VERSION OF NIVPD. E. Hokanson, Inc.·Product code DQK·1997-10-03
K971056 — MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSIONWrightmedicaltechnologyinc·Product code HSB·1997-10-03
K971131 — FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITORFukuda Denshi USA, Inc.·Product code DSI·1997-10-03
K971198 — BABYTHERM 8004 BABYTHERM 8010Drager, Inc.·Product code FMT·1997-10-03
K971257 — VTU-1 VACUUM ERECTION SYSTEMMckenna & Cuneo·Product code LKY·1997-10-03
K971947 — INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY)Sim Italia S.R.L.·Product code CAW·1997-10-03
K972169 — MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCEPwa Industries Sdn. Bhd.·Product code LZA·1997-10-03
K972514 — LASEREX LP1532 PHOTOCOAGULATOREllex Medical Pty, Ltd.·Product code HQF·1997-10-03
K972661 — EYE SPHERE, CONFORMERSGulden Ophthalmics·Product code HPZ·1997-10-03
K972697 — AIA-PACK IGE II ASSAYTosoh Medics, Inc.·Product code DGC·1997-10-03
K972844 — TEMP BOND CLEARKerr Dental Materials Center·Product code EMA·1997-10-03
K972895 — VIDAS ROTAVIRUS (RTV) ASSAYBiomerieux Vitek, Inc.·Product code LIQ·1997-10-03
K973088 — PLS-96PSouthern Dental Industries, Inc.·Product code EJJ·1997-10-03
K973294 — INNOVATOME MICROKERATOMEInnovative Optics, Inc.·Product code HNO·1997-10-03
K973389 — CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAININGVentana Medical Systems, Inc.·Product code DEM·1997-10-03
K973390 — CHEMMATE L26 (CD20)Ventana Medical Systems, Inc.·Product code DEM·1997-10-03
K973391 — CHEMMATE KAPPAVentana Medical Systems, Inc.·Product code DEM·1997-10-03
K973392 — CHEMMATE LAMBDAVentana Medical Systems, Inc.·Product code DEM·1997-10-03
K971004 — MEDCORP FLOW I.V. REGULATOR EXTENSION SETMedcorp Intl.·Product code FPA·1997-10-02
K971733 — 2 BOND 2Heraeus Kulzer, Inc.·Product code KLE·1997-10-02
K972445 — PULPDENT OX-OUTPulpdent Corp.·Product code EMA·1997-10-02
K972515 — SENSOR AMPLIFIERPro-Tech Services, Inc.·Product code GWL·1997-10-02
K972525 — THUMPERMichigan Instruments, Inc.·Product code DRM·1997-10-02
K972723 — BIO TROLMindmedia Labs, Inc.·Product code HCC·1997-10-02
K972871 — GENESISPacific Rim Dental, Inc.·Product code ELW·1997-10-02
K972892 — CAVIT-LCEspe GmbH & Co. Kg.·Product code EBF·1997-10-02
K973047 — ONE STEP URINE DRUG OF ABUSE BARBITURATE TESTDrial Consultants, Inc.·Product code DIS·1997-10-02
K973107 — AMSINO I.V. ADMINISTRATION SETAmsino Intl., Inc.·Product code FPA·1997-10-02
K960513 — PERACT 20 LIQUID STERILANTMinntech Corp.·Product code MED·1997-10-01
K970912 — LEIBINGER SELF-DRILLING SCREWHowmedica Leibinger, Inc.·Product code HWC·1997-10-01
K971184 — OXI-SNAPSnap Laboratories, LLC·Product code MNR·1997-10-01
K971523 — DISTALLY FIXED HIP STEMSulzer Orthopedics, Inc.·Product code MEH·1997-10-01
K971760 — COLORPOINT OR PROFESSIONAL COLORPOINTSeiko Instruments USA, Inc.·Product code LMC·1997-10-01
K971935 — B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)B & D Corp.·Product code JBP·1997-10-01
K972494 — DEPUY DUPONT ABSORBABLE SET SCREWDepuy, Inc.·Product code HWC·1997-10-01
K972501 — APOLLO REVISION/CONSTRAINED KNEE SYSTEMSulzer Orthopedics, Inc.·Product code JWH·1997-10-01
K972506 — INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATORInfinitech, Inc.·Product code HJM·1997-10-01
K972521 — NAVIGATOR (STYLET) 2006Sil-Med Corp.·Product code GAH·1997-10-01
K972530 — CONVATEC ODOR CONTROL WOUND DRESSINGConvatec, A Division of E.R. Squibb & Sons·Product code KMF·1997-10-01
K972570 — HEARTPORT INTRODUCER SHEATHHeartport, Inc.·Product code DYB·1997-10-01
K972578 — ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVEEthicon Endo-Surgery, Inc.·Product code GCJ·1997-10-01
K972579 — HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINEBaxter Healthcare Corp·Product code KDJ·1997-10-01
K972584 — STRYKER HUMMER II MICRODEBRIDER SYSTEMStryker Endoscopy·Product code ERL·1997-10-01
K972597 — PMT NEW BEGINNINGS GELSHAPES & AMENDPmt Corp.·Product code MDA·1997-10-01
K972617 — HELAX-VISIRHelax AB·Product code IYE·1997-10-01
K972635 — ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.·Product code GBX·1997-10-01
K972637 — PRECEDENT REVISION HIP SYSTEMSulzer Orthopedics, Inc.·Product code LZO·1997-10-01
K972662 — CRYOGEN CRYOSURGICAL SYSTEMCryogen, Inc.·Product code GEH·1997-10-01
K972685 — ORIGIN LIGATOR DEVICEOrigin Medsystems, Inc.·Product code GCJ·1997-10-01
K972703 — REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.·Product code GCY·1997-10-01
K972712 — CORE RESISTANT HUBER INFUSION SETSIcu Medical, Inc.·Product code FPA·1997-10-01
K972718 — M-2 ANTERIOR PLATE SYSTEMAcromed Corp.·Product code KWQ·1997-10-01
K972886 — MIRAGESegami Corp., Inc.·Product code LLZ·1997-10-01
K972891 — ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATIONRoche Diagnostic Systems, Inc.·Product code DKZ·1997-10-01
K973054 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSEmd Chemicals, Inc.·Product code DNN·1997-10-01
K973316 — REP SPE VIS-60/40 KITHelena Laboratories·Product code CEF·1997-10-01
K973362 — NEEDLE GUIDE/GRIDProtek Medical Products, Inc.·Product code ITX·1997-10-01
K970650 — ASAHI AM-R SERIES DIALYZERSAsahi Medical Co., Ltd.·Product code MSE·1997-09-30
K970854 — 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETERCordis Corp.·Product code DQO·1997-09-30
K972440 — CATARACTSCREENER CT - SNeitz Instruments Company, Ltd.·Product code HKI·1997-09-30
K972522 — ML-DISPOSABLE PAKMed-Logics, Inc.·Product code MSR·1997-09-30

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