FDA 510(k) clearances — page 887

176,637 clearances on record, most recent first.

Clearances — page 887

88,601–88,700 of 176,637

K990024 — CARESIDE ALKALINE PHOSPHATASECareside, Inc.·Product code CJE·1999-01-13
K981432 — GOLDMAN MANUAL TONOMETERGolden Vision, Inc.·Product code HKY·1999-01-12
K981997 — POSI-STOP/POSI-TRAC SYSTEMThe Dental Medical Device Co., LLC·Product code DZE·1999-01-12
K982159 — ABBOTT PLUM A+ INFUSION PUMPAbbott Laboratories·Product code FRN·1999-01-12
K983654 — CYBER-LASE 2000 CURING AND WHITENING LASERIcs of North America, Inc.·Product code GEX·1999-01-12
K983661 — BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIESBelmont Equipment Corp.·Product code EIA·1999-01-12
K983712 — AMPLAID A311 SERIESAmplifon S.P.A.·Product code EWO·1999-01-12
K984000 — STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEMSurgical Navigation Technologies, Inc.·Product code LMD·1999-01-12
K984159 — MEDRAD QUADRATURE CTL ARRAY COILMedrad, Inc.·Product code MOS·1999-01-12
K984167 — SAGE 7GE Medical Systems·Product code LNI·1999-01-12
K984255 — OLYMPUS HX-20 SERIES LIGATING DEVICEOlympus Corp of America·Product code MND·1999-01-12
K984307 — MODIFICATION OF: RHEO DOPPLEX IIHuntleigh Healthcare, Inc.·Product code IYN·1999-01-12
K981625 — STERRAD 50 STERILIZERAdvanced Sterilization Products·Product code MLR·1999-01-11
K983399 — GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAYGenzyme Diagnostics·Product code MHI·1999-01-11
K983563 — IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND IImcor·Product code DZE·1999-01-11
K983566 — 3-CHIP VIDEO CAMERAStryker Endoscopy·Product code GCJ·1999-01-11
K983597 — NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODESMedicotest, Inc.·Product code GXZ·1999-01-11
K983625 — S555 INTRAORAL DENTAL CAMERASopro·Product code EIA·1999-01-11
K983635 — JULIAN ANESTHESIA WORKSTATION, MODEL # JULIANDraeger Medical, Inc.·Product code BSZ·1999-01-11
K983849 — DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGEDade Behring, Inc.·Product code JHM·1999-01-11
K984123 — THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (EZeus Scientific, Inc.·Product code LHL·1999-01-11
K984126 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.·Product code MCD·1999-01-11
K984133 — THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.·Product code LLM·1999-01-11
K984139 — THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THEZeus Scientific, Inc.·Product code LFZ·1999-01-11
K984153 — THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.Zeus Scientific, Inc.·Product code LJZ·1999-01-11
K984444 — INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000Sandhill Scientific, Inc.·Product code FFX·1999-01-11
K984456 — COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIRCobe Cardiovascular, Inc.·Product code DTN·1999-01-11
K984516 — THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DETZeus Scientific, Inc.·Product code MOB·1999-01-11
K962918 — LIDCO SYSTEMLidco, Ltd.·Product code DXG·1999-01-08
K982181 — TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZERTrudell Medical·Product code CAF·1999-01-08
K982272 — GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018Biotronik, Inc.·Product code DQX·1999-01-08
K982754 — EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)A.Stein - Regulatory Affairs Consulting·Product code FWF·1999-01-08
K983569 — KSEA MONOPOLAR VAPORIZATION ELECTRODESKARL STORZ Endoscopy-America, Inc.·Product code HIH·1999-01-08
K983574 — STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTSDentalez Group·Product code EGS·1999-01-08
K983607 — LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTSLabtician Ophthalmics, Inc.·Product code MML·1999-01-08
K983620 — MANAN SPINAL NEEDLESManan Medical Products, Inc.·Product code BSP·1999-01-08
K983707 — JMS DIALYZER PRIMING SETJms Co., Ltd.·Product code KOC·1999-01-08
K983962 — ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVESCardinal Health,Medical Products and Services·Product code KGO·1999-01-08
K983994 — UNIFINEOwen Mumford USA, Inc.·Product code FMF·1999-01-08
K984064 — OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREEOmni Intl., Inc.·Product code KGO·1999-01-08
K984246 — PROMPT L-POPEspe Dental AG·Product code KLE·1999-01-08
K984248 — PROCEMEspe Dental AG·Product code EMA·1999-01-08
K984340 — STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281Sterngold/Implamed·Product code EMA·1999-01-08
K984341 — STERNVANTAGE VARNISH LC, MODEL 221001Sterngold/Implamed·Product code EBI·1999-01-08
K984356 — NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)Perusahaan Getah Asas Sdn. Bhd.·Product code LZA·1999-01-08
K984447 — MODEL ACTION AT II MANUAL WHEELCHAIRInvacare Corp.·Product code IOR·1999-01-08
K984493 — MAXXIM; MAXXIM HDMajor Mobility Products, Inc.·Product code IOR·1999-01-08
K972335 — CLEANCUTMedquest Products, Inc.·Product code GEI·1999-01-07
K983547 — PROTECH PLUSProtech, Inc.·Product code EBI·1999-01-07
K983550 — XYZ SYSTEMBio-Monitoring International Corp.·Product code HCC·1999-01-07
K983552 — BASIC, MEDIAN, DOMINANT, AND VARIOMedela, Inc.·Product code BTA·1999-01-07
K983558 — ACETAL DENTAL/PREFORMED CLASPDentamax, Inc.·Product code EHP·1999-01-07
K983567 — IMAGE TECHNOLOGIES STERICAM, COUPLER-DRAPE AND TROVIEW IMAGING SYSTEMMed Images, Inc.·Product code GCJ·1999-01-07
K983735 — PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANEPall Medical·Product code EIA·1999-01-07
K983902 — FIELD EFFECTS MRI SYSTEMIntermagnetics General Corp.·Product code LNH·1999-01-07
K983977 — LIGHT AGE EPICARE ALEXANDRITE LASERLight Age, Inc.·Product code GEX·1999-01-07
K984068 — FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESISSchneider (Europe) GmbH·Product code ESW·1999-01-07
K984197 — FLUOROTEX SURGICAL MESHBridger Biomed, Inc.·Product code FTL·1999-01-07
K984435 — MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609MMedtronic Vascular·Product code KRH·1999-01-07
K984438 — MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGEUnited States Surgical, A Division of Tyco Healthc·Product code FZP·1999-01-07
K982928 — NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEMRadiometer America, Inc.·Product code CHL·1999-01-06
K982988 — PRECISION UV (VASURFILCON A)Wesley Jessen Corp.·Product code LPL·1999-01-06
K983347 — OSSEOTITE DENTAL IMPLANTSImplant Innovations, Inc.·Product code DZE·1999-01-06
K983898 — BIOCLOT APC SENSITIVITYBiopool Intl., Inc.·Product code GGP·1999-01-06
K983937 — DUAL VIAL CREATININE REAGENTIntersect Systems, Inc.·Product code CGX·1999-01-06
K984522 — MODIFICATION OF TSRH SPINAL SYSTEMDanek Medical, Inc.·Product code MNI·1999-01-06
K983565 — SYSTEM U3 FOR NITROFURANTOINAb Biodisk·Product code JWY·1999-01-05
K981376 — HEWLETT-PACKARD M1205A VIRIDIA 24 CTHewlett-Packard Co.·Product code DSI·1999-01-04
K983679 — STATIM 5000 CASSETTE AUTOCLAVEScican·Product code FLE·1999-01-04
K981680 — ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSISDayton Water Systems·Product code FIP·1998-12-31
K983529 — INSTATRAK 3000Visualization Technology, Inc.·Product code LLZ·1998-12-31
K983770 — 'RAPID DRUG SCREEN' 9-PANELAmerican Bio Medica Corp.·Product code DKZ·1998-12-31
K984458 — DEPUY ACE SPIDER PLATEDepuy Ace Medical Co.·Product code HRS·1998-12-31
K982142 — MOUNTABLE ENDOSCOPIC KNIFEA.M. Surgical, Inc.·Product code EMF·1998-12-30
K982549 — RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLCRadionics, Inc.·Product code IYE·1998-12-30
K982791 — ROCS TPSRadiation Oncology Computer Systems·Product code MUJ·1998-12-30
K983055 — RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003Guidant Corp.·Product code LIT·1998-12-30
K983267 — DIGORA FOR WINDOWS 2.0Orion Corporation Soredex·Product code MUH·1998-12-30
K983519 — COMFEEL SEASORB DRESSINGColoplast Corp.·Product code KMF·1998-12-30
K983571 — SYSTEM U3 FOR TETRACYCLINEAb Biodisk·Product code JWY·1998-12-30
K983622 — BODYFORM THORACO-LUMBAR FIXATION SYSTEMTheken Surgical,Llc·Product code KWQ·1998-12-30
K983747 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS IIBeckman Coulter, Inc.·Product code DKB·1998-12-30
K983761 — AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5Aaron Medical Industries·Product code GEI·1998-12-30
K983873 — SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEMSyntec Scientific Corp.·Product code KTT·1998-12-30
K983976 — METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEMMetagen, LLC·Product code JDQ·1998-12-30
K984342 — ANTERIOR CERVICAL PLATING SYSTEMUnited States Surgical, A Division of Tyco Healthc·Product code KWQ·1998-12-30
K984378 — DEPUY ACROMED MOSS SPINAL SYSTEMDepuy, Inc.·Product code MNI·1998-12-30
K984401 — NEUROMAG VECTORVIEWPhilips Medical Systems (Cleveland), Inc.·Product code OLX·1998-12-30
K984414 — XRE COLLIMATOR WITH SPECTRAL FILTERTrex Medical Corp.·Product code IZW·1998-12-30
K984431 — ULTIMA AIRFLOW PRESSURE SENSORBraebon Medical Corp.·Product code BZQ·1998-12-30
K974332 — VARIABLE PRESSURE SYRINGE PUMPAlaris Medical Systems, Inc.·Product code FRN·1998-12-29
K982337 — CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZERHaidylena Medical Egypt·Product code FJI·1998-12-29
K983535 — THE TITANIUM MINIPLATING SYSTEM, THE TITANIUM MICROPLATING SYSTEM, THE TITANIUM MEDIUMPLATING SYSTEM, MODEL #'S H12-1010Hans Hermann GmbH·Product code JEY·1998-12-29
K983990 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAYOrtho-Clinical Diagnostics, Inc.·Product code CGR·1998-12-29
K984164 — JELBOND NPJelenko Co.·Product code EJH·1998-12-29
K980878 — PULMOTRACK,MODEL 1010Karmel Medical Acoustic Technologies , Ltd.·Product code BZM·1998-12-28
K982562 — BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMERIntegrated Orbital Implants, Inc.·Product code HPZ·1998-12-28
K983484 — DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODEEmpi·Product code EGJ·1998-12-28
K983921 — AUTOSTAT II ENA SCREEN ELISACogent Diagnotics , Ltd.·Product code LLL·1998-12-28
K983952 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner Meditech, Inc.·Product code JKA·1998-12-28

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