FDA 510(k) clearances — page 1083

176,637 clearances on record, most recent first.

Clearances — page 1083

108,201–108,300 of 176,637

K942257 — DOA-PLUS, DRUGS OF ABUSE CONTROLSMedical Diagnostic Technologies, Inc.·Product code DIF·1994-09-14
K943047 — IV START KITSSterile Concepts, Inc.·Product code KMK·1994-09-14
K943290 — BILIRUBIN PLUS/PEDIATRIC CONTROLSMedi-Tech, Inc.·Product code JJY·1994-09-14
K943296 — ILO MADE IN ITALY; GARBO HAND FINISHED ITALYIlo Industria Lombarda Ottica Srl·Product code HQY·1994-09-14
K943376 — OPERA SYSTEMMiles, Inc.·Product code JJC·1994-09-14
K943561 — SPECTACLE FRAMEAustralian Optical Co., Inc.·Product code HQZ·1994-09-14
K943562 — SUNGLASSESAustralian Optical Co., Inc.·Product code HQY·1994-09-14
K943640 — SUNGLASS CLIPAustralian Optical Co., Inc.·Product code HQY·1994-09-14
K943641 — SPECTACLE FRAMEAustralian Optical Co., Inc.·Product code HQZ·1994-09-14
K943697 — TROCARS,CANNULAE,SHEATHS,OBTURATORSKarl Storz Endoskop GmbH·Product code ODB·1994-09-14
K943704 — LIPASE CALIBRATORThe DU Pont Co.·Product code JIT·1994-09-14
K943754 — BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCTBionostics, Inc.·Product code JJY·1994-09-14
K943786 — PORTLAND TROCARSMikroland Micromecanique·Product code GCJ·1994-09-14
K943792 — SPECTACLE FRAMESKt Optique, Inc.·Product code HQZ·1994-09-14
K943963 — NILMax-Vision (H.K.)Limited·Product code HQY·1994-09-14
K944026 — MIRAGE EYEWEAR INC.Mirage Eyewear, Inc.·Product code HQY·1994-09-14
K944107 — VIP PLUS PERCUTANEOUS INTRODUCERMedamicus, Inc.·Product code DYB·1994-09-14
K944108 — NILMicron Metal & Plastic Manufactory Co.·Product code HQY·1994-09-14
K944109 — NILKeep Top Intl., Ltd.·Product code HQY·1994-09-14
K940231 — INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTIONDatascope Corp.·Product code DSP·1994-09-13
K940731 — INNERVISION INC. CANNULA/TROCAR,MULTIPLE TYPESInnervision, Inc.·Product code GCJ·1994-09-13
K944082 — ASLAN DUAL ACTION JAWS GRASPING FORCEPSAslan Medical Technologies, Ltd.·Product code GCJ·1994-09-13
K944104 — GABRIS LAPAROSCOPIC SURGICAL KITSGabris Surgical Corp.·Product code FBQ·1994-09-13
K944122 — DAB WELDLESS WHEELCHAIRDa Intl. , Ltd.·Product code IOR·1994-09-13
K944194 — DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HMEMed-Tek Innovations, Inc.·Product code BYD·1994-09-13
K922990 — HEMODIALYSIS BATHMedi-Tech, Inc.·Product code KPO·1994-09-12
K933108 — TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESISLandos, Inc.·Product code LZO·1994-09-12
K935279 — KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II RIGID AUTOCLAVABLE TELESCOPEKARL STORZ Endoscopy-America, Inc.·Product code GCJ·1994-09-12
K940736 — HAIG NAILHowmedica Corp.·Product code JDS·1994-09-12
K941853 — PASSPORTBoston Scientific Corp·Product code EZN·1994-09-12
K943111 — TRANSPARENT DRESSINGAcutek Adhesive Specialties, Inc.·Product code MGP·1994-09-12
K943388 — GC SURFLEX FGC America, Inc.·Product code ELW·1994-09-12
K943989 — LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENTGabris Surgical Corp.·Product code HFO·1994-09-12
K944103 — LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTGabris Surgical Corp.·Product code GCJ·1994-09-12
K924565 — SBS MODEL 1615Stand-By-Systems, Inc.·Product code CAW·1994-09-09
K932522 — AMSCO STERILE RECOVERIES SURGICAL PACKSAmsco Sterile Recoveries, Inc.·Product code LRD·1994-09-09
K933486 — FASCOUNT SYSTMEBecton Dickinson Immunocytometry Systems·Product code GKZ·1994-09-09
K934125 — GONOCHEK-II, MODIFICATIONE-Y Laboratories, Inc.·Product code JTO·1994-09-09
K934759 — CULTURIA MACCONKEY-MUGClinical Convenience Products, Inc.·Product code JXA·1994-09-09
K935896 — THIXOFLEXZhermack Dental Production·Product code ELW·1994-09-09
K935927 — CONCORD/PORTEX EPIDURAL CATHETERSSmiths Industries Medical Systems, Inc.·Product code BSO·1994-09-09
K936002 — CINEMAC QASXre Corp.·Product code IZI·1994-09-09
K940161 — B-LACTAMASE REAGENT TUBESE-Y Laboratories, Inc.·Product code JTO·1994-09-09
K940162 — GONOCHEK II REAGENT TUBESE-Y Laboratories, Inc.·Product code JTO·1994-09-09
K940469 — URINE REAGENT STRIP-3 PARAMETERSTeco Diagnostics·Product code JIL·1994-09-09
K940594 — KARL STORZ ADULT & PEDIATRIC NEPHROSCOPEKARL STORZ Endoscopy-America, Inc.·Product code FGA·1994-09-09
K940679 — REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222Helena Laboratories·Product code JHO·1994-09-09
K941336 — COMBO MASKGam Industries, Inc.·Product code KGB·1994-09-09
K941346 — PLASMINOGEN RID TEST KITThe Binding Site, Ltd.·Product code DDX·1994-09-09
K942098 — PROSPECT GIARDIAAlexon, Inc.·Product code MHI·1994-09-09
K942520 — E-VAC-U-ACCESSORIESBull Frog Mfg. Co.·Product code EIA·1994-09-09
K942552 — THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYEDMedi-Tech, Inc.·Product code DIF·1994-09-09
K942560 — MAGNETIC RESONANCE DIAGNOSTIC DEVICEHitachi Medical Systems America, Inc.·Product code LNH·1994-09-09
K942632 — TNT TROPONIN TStreck Laboratories, Inc.·Product code JJX·1994-09-09
K942640 — DUPONT DIMENSION AMYLASE METHODDupont Medical Products·Product code JFJ·1994-09-09
K942991 — QMS THEOPHYLLINE CSSeradyn, Inc.·Product code LGS·1994-09-09
K943182 — ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOROral-B Laboratories·Product code EFS·1994-09-09
K943414 — PROPOXPHENE EIA TESTDiagnostic Reagents, Inc.·Product code JXN·1994-09-09
K943485 — MONOJECT HORIZONTAL ENTRY SHARPS CONTAINERSherwood Medical Co.·Product code FMI·1994-09-09
K943620 — MICRO-TOUCH LATEX MEDICAL GLOVESJohnson & Johnson Medical, Inc.·Product code LYY·1994-09-09
K943702 — AVL 988-4 ELECTROLYTE ANALYZERAvl Scientific Corp.·Product code JFP·1994-09-09
K943711 — EZ-SCREEN:PCPEditek, Inc.·Product code LCM·1994-09-09
K943738 — OPTIBOND-DSybron Dental Specialties, Inc.·Product code KLE·1994-09-09
K943755 — SOLDER AUROLITE CBArgen Precious Metals, Inc.·Product code EJT·1994-09-09
K943757 — SOLDER AUROLITE REPAIRArgen Precious Metals, Inc.·Product code EJT·1994-09-09
K923656 — LIGHTING SOURCE SYSTEMGalenica Enterprises, Inc.·Product code HIC·1994-09-08
K931143 — AMSCO STERILE RECOVERIES ABSORBENT TOWELSAmsco Sterile Recoveries, Inc.·Product code KKX·1994-09-08
K932295 — NON-BALLOON REPLACEMENT GASTROSTOMY KITBiosearch Medical Products, Inc.·Product code KNT·1994-09-08
K933237 — MEDI-STIM, MODIFICATIONMid-Canada Medical·Product code GZJ·1994-09-08
K934072 — CONVENIENCE CONTOUR KITS REDI NURSE SYSTEMContour Fabricators of Florida, Inc.·Product code KNY·1994-09-08
K934741 — LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2Clinical Controls, Inc.·Product code GIL·1994-09-08
K941688 — INNOVATIVE TECHNOLOGIES HYDROCOLLOID WOUND DRESSINGSInnovative Technologies , Ltd.·Product code FRO·1994-09-08
K942177 — FOLEY CATHETERIZATION TRAYCustomed, Inc.·Product code FCM·1994-09-08
K942494 — LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENSPermeable Technologies, Inc.·Product code LPL·1994-09-08
K942916 — OCTOPAQUE UNIVERSALOctostop, Inc.·Product code IXQ·1994-09-08
K943298 — MS CLASSIQUE BALLOON CATHETERMeadox Medicals, Div. Boston Scientific Corp.·Product code LIT·1994-09-08
K943495 — DISPOSABLE ESOPHAGEAL STETHOSCOPECoast Medical, Inc.·Product code BZT·1994-09-08
K943663 — NAVARRE 600 ML DRAINAGE BAGNavarre Biomedical , Ltd.·Product code EXF·1994-09-08
K944045 — SURGI-LINK ENDOSCOPIC BIPOLAR FORCEPSUnimed Surgical Products, Inc.·Product code GEI·1994-09-08
K944124 — SPIROBAC ADAPTERSMallinckrodt Medical·Product code CAH·1994-09-08
K915166 — MICROCYCLERMedical Inventors Corp., Inc.·Product code FCN·1994-09-07
K932210 — ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENTDow Corning Wright·Product code JWH·1994-09-07
K933681 — GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.·Product code FJG·1994-09-07
K933802 — CUTANEOUS ELECTRODECadwell Laboratories, Inc.·Product code GXY·1994-09-07
K934166 — NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATIONCorin Orthopedic Products·Product code JWH·1994-09-07
K934752 — SIEMENS MODEL 584 P-2Siemens Hearing Instruments, Inc.·Product code ESD·1994-09-07
K935019 — INFINITY 252Siemens Hearing Instruments, Inc.·Product code ESD·1994-09-07
K935163 — CONTINUOUS IRRIGATION CYSTOURETHROSCOPERichard Wolf Medical Instruments Corp.·Product code FBO·1994-09-07
K935737 — STONE EXTRACTOR, GRASPING FORCEPSBoston Scientific Corp·Product code FFL·1994-09-07
K936079 — ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENTExactech, Inc.·Product code JWH·1994-09-07
K940243 — VENTANA EMA PRIMARY ANDIBODYVentana Medical Systems, Inc.·Product code DHF·1994-09-07
K940427 — KARL STORZ THORACIC SURGERY INSTRUMENTSKARL STORZ Endoscopy-America, Inc.·Product code GCJ·1994-09-07
K940833 — ACCESS(R) TOTAL T3Bio-Rad Laboratories, Inc.·Product code CDP·1994-09-07
K940842 — UNIPOWER RECHARGEABLE BATTERY PACKUnipower Corp.·Product code LDD·1994-09-07
K941168 — CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KITIncstar Corp.·Product code CHP·1994-09-07
K941195 — CEDIA DAU OPIATE ASSAYMicrogenics Corp.·Product code DJG·1994-09-07
K941878 — OCTEIA INTACT PTHI.D.S.·Product code CEW·1994-09-07
K942638 — SIMULTRAC LH/FSH RADIOUMMUNOASSAY KITBd Becton Dickinson Vacutainer Systems Preanalytic·Product code CEP·1994-09-07
K942660 — HALL MICROCHOICE ELECTRIC POWERED SYSTEMHall Surgical, Division of Zimmer, Inc.·Product code HWE·1994-09-07
K943098 — HUMAN IGG SUBCLASSES ELISA COMBI KITResearch Diagnostics, Inc.·Product code DAS·1994-09-07

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