FDA 510(k) clearances — page 1078

176,637 clearances on record, most recent first.

Clearances — page 1078

107,701–107,800 of 176,637

K935394 — MAC-LAB ELECTROPHYSIOLOGY MODULE OPTIONMarquette Electronics, Inc.·Product code DPS·1994-10-20
K935726 — EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENTExactech, Inc.·Product code JWH·1994-10-20
K936087 — CARPAL BOXInnovative Medical Technologies, Inc.·Product code KPR·1994-10-20
K936126 — HOWMEDICS DRG FEMORAL COMPONENTHowmedica, Inc.·Product code JDI·1994-10-20
K941391 — INFLATABLE RETENTION CUFF SPECULUMInnovatec Medical Corp.·Product code GBT·1994-10-20
K941765 — HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USETcpi, Inc.·Product code LCX·1994-10-20
K942162 — SIGMA 8000 AND SIGMA 8002Sigma Intl.·Product code FRN·1994-10-20
K942328 — N LATEX RFBehring Diagnostics, Inc.·Product code DHR·1994-10-20
K942610 — KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)Eastman Kodak Company·Product code LFM·1994-10-20
K943019 — CEDIA T4 MAB ASSAYMicrogenics Corp.·Product code KLI·1994-10-20
K943188 — SEALITE SCIENCE, INC. AQUALITE(R) LHSealite Sciences, Inc.·Product code CEP·1994-10-20
K943241 — DMA GLUCOSE (OXIDASE) PROCEDUREData Medical Associates, Inc.·Product code CGA·1994-10-20
K943278 — TRACKER 2/TRACKER 3 HOLTER RECORDERReynolds Medical , Ltd.·Product code DSH·1994-10-20
K943472 — COHORT AVB RETRACTOR SYSTEMCohort Medical Products Group, Inc.·Product code HXB·1994-10-20
K943687 — FEDELITY F495, VIENNATONE ALPP IIStarkey Laboratories, Inc.·Product code ESD·1994-10-20
K943701 — MRX MICROPLATE READERDynatech Laboratories, Inc.·Product code JJQ·1994-10-20
K943732 — LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCEGraphic Controls Corp.·Product code HGP·1994-10-20
K943784 — MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEARMenicon Co, Ltd.·Product code HQD·1994-10-20
K943941 — SAFESTART VASCULAR ACCESS START KITBecton Dickinson Vascular Access, Inc.·Product code LRS·1994-10-20
K943960 — UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALSMiracle-Ear, Inc.·Product code ESD·1994-10-20
K943996 — DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHODDupont Medical Products·Product code CEP·1994-10-20
K944089 — AVL OPTI PH/BLOOD GAS ANALYZERAvl Scientific Corp.·Product code CHL·1994-10-20
K944129 — IMAGYN LAPAROSCOPIC INSTRUMENTSImagyn Medical, Inc.·Product code HET·1994-10-20
K944502 — BELTONE CONCERTO SBeltone Electronics Corp.·Product code ESD·1994-10-20
K944706 — REDA LAPAROSCOPIC INSTRUMENTS GER-MAIN PRIME ENDO LAPAROSCOPIC INSTRUMENTSReda Instrumente GmbH·Product code GEI·1994-10-20
K944772 — MULTIPLE ED1600 SERIES RADIATION SHIELDSImage Diagnostics, Inc.·Product code EAK·1994-10-20
K944838 — WIDEX MODEL LX-ITEWidex Hearing Aid Co., Inc.·Product code ESD·1994-10-20
K934323 — DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DILBaxter Diagnostics, Inc.·Product code JWY·1994-10-19
K935113 — J.B.S. IMPLANTABLE SPINAL FIXATION DEVICEJ.B.S., S.A.·Product code KWP·1994-10-19
K935280 — MEMOTHERM 10 BABY THERMOMETERInternational Regulatory Consultants·Product code FLL·1994-10-19
K935321 — INNOVASIVE SUTURE BONE FASTENER WITH SUTUREInnovasive Devices, Inc.·Product code JDR·1994-10-19
K941787 — LATEX EXAM GLOVESP.T. Irama Dinamika Latex·Product code LYY·1994-10-19
K942461 — NEUROLOGY ACCESSORIES - MARK-EASY 10-20Optimit USA, Inc.·Product code GXY·1994-10-19
K943539 — AIMS CANNULATED ACL SCREWSmith & Nephew, Inc.·Product code HWC·1994-10-19
K943734 — MEDICAL SUPPORT STOCKINGS 2001/2002Julius Zorn, Inc.·Product code DWL·1994-10-19
K944494 — ALSA-KLENZCalgon Vestal Div.·Product code FLG·1994-10-19
K944517 — PASCO MIC AND MIC/ID PANELSPasco Laboratories, Inc.·Product code JWY·1994-10-19
K944738 — SERIES 600 CENTRIFUGE-FOUR SEPARATE VARIATIONS OF THE SAME BASE CENTRIFUGEDucker CL·Product code JQC·1994-10-19
K944855 — CHROMOPHAREBerchtold Holding GmbH·Product code FSY·1994-10-19
K923946 — CONCHATHERM IV HEATED MOLECULAR HUMIDIFIERHudson Respiratory Care, Inc.·Product code BTT·1994-10-18
K926334 — AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSEROrthomet, Inc.·Product code JWH·1994-10-18
K934016 — POWERCHARGERZoll Medical Corp·Product code DTE·1994-10-18
K935126 — NASCOR IGLOONascor Pty. , Ltd.·Product code BYL·1994-10-18
K935349 — LOCALMED INFUSION CATHETERLocalmed, Inc.·Product code KRA·1994-10-18
K935597 — FASGUIDE CATHETERTarget Therapeutics·Product code DQY·1994-10-18
K940957 — HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEMInternational Technidyne Corp.·Product code JPA·1994-10-18
K941706 — OPTI-PLAST ANGIOPLASTY CATHETERVas-Cath, Inc.·Product code LIT·1994-10-18
K942269 — MEDTRONIC EVEREST INFLATION DEVICEMedtronics Interventional Vascular·Product code MAV·1994-10-18
K942293 — MS CLASSIQUE BALLOON CATHETERMeadox Medicals, Div. Boston Scientific Corp.·Product code LIT·1994-10-18
K942470 — PROTECTAIDE PERSONAL PROTECTION PACK NO. 08315Protectaide, Inc.·Product code FXX·1994-10-18
K942471 — PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777Protectaide, Inc.·Product code FXX·1994-10-18
K942472 — PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123Protectaide, Inc.·Product code FXX·1994-10-18
K942473 — PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592Protectaide, Inc.·Product code FXX·1994-10-18
K942474 — PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000Protectaide, Inc.·Product code FXX·1994-10-18
K942475 — PROTECTAIDE PERSONAL PROTECTION PACK NO. 12351Protectaide, Inc.·Product code FXX·1994-10-18
K942476 — PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069Protectaide, Inc.·Product code FXX·1994-10-18
K942670 — GC PATTERN RESINGC America, Inc.·Product code EBG·1994-10-18
K943598 — FLEXIBLE FIBER OPTIC LAPAROSCOPESOptimed Technologies, Inc.·Product code HET·1994-10-18
K943644 — IMPLANTECH TEMPORAL IMPLANTImplantech Associates, Inc.·Product code FWP·1994-10-18
K943817 — MARQUETTE ADULT/NEONATAL WRAP SENSORMarquette Electronics, Inc.·Product code DQA·1994-10-18
K944510 — VINYL EXAMINATION GLOVE, POWDER-FREEAmerican Gemini, Inc.·Product code LYZ·1994-10-18
K944560 — MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYSTKLS-Martin L.P.·Product code JEY·1994-10-18
K944561 — MICRO OSTEOSYNTHESIS SYSTEM (1.0)KLS-Martin L.P.·Product code JEY·1994-10-18
K944565 — KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)KLS-Martin L.P.·Product code JEY·1994-10-18
K922088 — FRESENIUS DIALYSATE ACID CONCENTRATEFresenius USA, Inc.·Product code KPO·1994-10-17
K925195 — MALIBU BATHING SYSTEMMedi-Man Rehabilitation Products, Inc.·Product code ILJ·1994-10-17
K930912 — HYSTEROMED 100Northgate Technologies, Inc.·Product code HIG·1994-10-17
K934684 — PAM CARDIAC MONITORTechnology Transfer, Inc.·Product code DRT·1994-10-17
K941982 — CAPNOCHECKBci, Inc.·Product code CCK·1994-10-17
K942871 — PRESS-MATE BP8800MS AUTOMATIC NON-INVASIVE BLOOD PRESSURE SYSTEMColin Medical Instruments Corp.·Product code DXN·1994-10-17
K943288 — AMSCO SQ240 SURGICAL LIGHTAmerican Sterilizer Co.·Product code FSY·1994-10-17
K943342 — MEDICAM XENON LIGHT SOURCEM.P. Video, Inc.·Product code FSW·1994-10-17
K943456 — AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSATDatex Division Instrumentarium Corp.·Product code DQA·1994-10-17
K943586 — ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)Biomet, Inc.·Product code LZO·1994-10-17
K944345 — BEDSIDE BUTLERTrac Medical, Inc.·Product code IQA·1994-10-17
K944574 — LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)Lumex, Inc.·Product code IOR·1994-10-17
K944760 — DURA-Y OXYGEN TRANSDUCER, EAR CLIPNellcor, Inc.·Product code DPZ·1994-10-17
K944849 — 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBEConmed Andover Medical, Inc.·Product code DRX·1994-10-17
K925209 — MUMPS STATBiowhittaker Molecular Applications, Inc.·Product code LJY·1994-10-14
K925613 — PROXIMAL HUMERAL REPLACEMENT SYSTEMBiomet, Inc.·Product code KWT·1994-10-14
K931333 — ORTHOMET ACETABULAR CUP SYSTEMOrthomet, Inc.·Product code LPH·1994-10-14
K931678 — ORTHOMET LHMC FEMORAL STEMOrthomet, Inc.·Product code HMC·1994-10-14
K932677 — AXIOM TOTAL KNEE SYSTEMOrthomet, Inc.·Product code JWH·1994-10-14
K933942 — SOLUTION BOWED FEMORAL HIP PROTSTHESISDepuy, Inc.·Product code LZO·1994-10-14
K934868 — LORAD TRANSPOLorad Corp.·Product code IZH·1994-10-14
K935090 — CUFF-CATHOhmeda Medical·Product code FOZ·1994-10-14
K935593 — ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEMBiodynamic Technologies, Inc.·Product code HSD·1994-10-14
K936232 — BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDERBoston Scientific Corp·Product code DSP·1994-10-14
K940634 — MICRO THERAPEUTICS INFUSION CATHETERMicro Therapeutics, Inc.·Product code FOZ·1994-10-14
K940927 — RESCUE BREATHERO-Two Systems Intl., Inc.·Product code CBP·1994-10-14
K940982 — ARTERIAL EMBOLIZATION DEVICE (KRD)Cook, Inc.·Product code KRD·1994-10-14
K941606 — PRESERVATION UNICOMPARTMENTAL KNEEDepuy, Inc.·Product code HSX·1994-10-14
K942966 — AML TRILOCK REPLACEMENT LINER SYSTEMDepuy, Inc.·Product code JDI·1994-10-14
K943021 — MRT-150AToshiba America Mri, Inc.·Product code LNH·1994-10-14
K943302 — AML TRI-LOCK REPLACEMENT LINER SYSTEMDepuy, Inc.·Product code JDI·1994-10-14
K943474 — CANNULATED BONE SCREWCohort Medical Products Group, Inc.·Product code HWC·1994-10-14
K943575 — B-D GUARDIAN NESTABLE SHARPS COLLECTORSBd Becton Dickinson Vacutainer Systems Preanalytic·Product code FMI·1994-10-14
K943837 — CHIN UPEdward Carden·Product code CCX·1994-10-14
K943904 — RIGID TELESCOPESKarl Storz Endoskop GmbH·Product code ENZ·1994-10-14
K943915 — HEAT AND MOISTURE EXCHANGER FILTER (HME)Medicomp, Inc.·Product code BYD·1994-10-14

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