FDA 510(k) clearances — page 883

176,637 clearances on record, most recent first.

Clearances — page 883

88,201–88,300 of 176,637

K973910 — GLIADIN ANTIBODIES ELISAGenesis Diagnostics , Ltd.·Product code MST·1999-02-17
K982721 — BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEMBionx Implants, Inc.·Product code JEY·1999-02-17
K983032 — CBC-5D HEMATOLOGY CONTROLR&D Systems, Inc.·Product code JPK·1999-02-17
K983368 — CARE BAND ANTIBACTERIAL BANDAGESAso Corp.·Product code KGX·1999-02-17
K983650 — BIPORE BALLOON DILATATION CATHETERBipore, Inc.·Product code LIT·1999-02-17
K984199 — EXONIXFibra Sonics, Inc.·Product code IMI·1999-02-17
K984615 — POWDERED NITRILE EXAMINATION GLOVESShiva Medicare , Ltd.·Product code LZA·1999-02-17
K990046 — PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMAPacific Hemostasis·Product code GJT·1999-02-17
K981829 — IS EBV-EBNA-1 IGG ELISA TEST SYSTEMDiamedix Corp.·Product code GNP·1999-02-16
K981831 — IS EBV-EA-D IGG ELISA TEST SYSTEMDiamedix Corp.·Product code GNP·1999-02-16
K982599 — THE FREMSTAD RINGOphthalmic Solutions, LLC·Product code HOZ·1999-02-16
K983070 — CKAbbott Laboratories·Product code CGS·1999-02-16
K984075 — INSTANT-VIEW PREGNANCY URINE MID-STREAM TESTAlfa Scientific Designs, Inc.·Product code LCX·1999-02-16
K984076 — INSTANT-VIEW PREGNANCY URINE TESTAlfa Scientific Designs, Inc.·Product code JHI·1999-02-16
K984077 — INSTANT-VIEW PREGNANCY COMBO TESTAlfa Scientific Designs, Inc.·Product code JHI·1999-02-16
K984079 — INSTANT-VIEW PREGNANCY URINE DIP-STRIP TESTAlfa Scientific Designs, Inc.·Product code JHI·1999-02-16
K984080 — INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TESTAlfa Scientific Designs, Inc.·Product code JHI·1999-02-16
K984089 — ZYMED TELEMETRY SYSTEM, MODEL EASI VIEWZymed Medical Instrumentation·Product code DSI·1999-02-16
K984136 — BARDEX LUBRI-SIL I.C. FOLEY CATHETERBard Medical Div.·Product code MJC·1999-02-16
K984143 — FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEMFibra Sonics, Inc.·Product code HQC·1999-02-16
K984463 — QUANTASE PHE/GAL SCREENING ASSAYQuantase , Ltd.·Product code JNB·1999-02-16
K984489 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATESAccumed Intl., Inc.·Product code JWY·1999-02-16
K984523 — IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENSIgel Vision Care Pte , Ltd.·Product code LPL·1999-02-16
K990160 — MICROTAC-BONE ANCHOR SYSTEMInfluence, Inc.·Product code MBI·1999-02-16
K990216 — MAGNETIC TIBC KITReference Diagnostics, Inc.·Product code JMO·1999-02-16
K990255 — DIMENSION DRUG CALIBRATOR II, MODEL DC49BDade Behring, Inc.·Product code DKB·1999-02-16
K980723 — 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)Vascutech, Inc.·Product code MGZ·1999-02-12
K981913 — PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAYChembio Diagnostic Systems, Inc.·Product code LSR·1999-02-12
K982333 — MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAYCook, Inc.·Product code MSD·1999-02-12
K982371 — MEDCO ASPIRATOR IVMedco Mfg.·Product code BTA·1999-02-12
K982915 — SCI-PHARM DFV VARNISHScientific Pharmaceuticals, Inc.·Product code LBH·1999-02-12
K983010 — SELF CATH SET/SAFETY CATHRusch Intl.·Product code FCM·1999-02-12
K983016 — GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.·Product code EFQ·1999-02-12
K983104 — NORIAN PERIODONTAL/DENTAL CEMENT (PDC)Norian Corp.·Product code LYC·1999-02-12
K983539 — TRAJECTORY GUIDE, MODEL # TGX-XXXImage-Guided Neurologics, Inc.·Product code HAW·1999-02-12
K983887 — UP-GRADE AND UP-GRADE PROMedisim, Ltd.·Product code FLL·1999-02-12
K984106 — MAMMARY SIZER, MAMMARY PROTHESIS SIZERSpecialty Surgical Products, Inc.·Product code MRD·1999-02-12
K984109 — AESCULAP AXIAL CLIP APPLIERAesculap, Inc.·Product code HCI·1999-02-12
K984115 — SCAREASE & SCAREASE ADHESIVE GELScarease, Inc.·Product code MDA·1999-02-12
K984134 — NATURA DENTURE TEETHDavis Schottlander & Davis, Ltd.·Product code ELM·1999-02-12
K984221 — FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MRSiemens Corp.·Product code LNH·1999-02-12
K984309 — NBR 4 MILS, NITRILE EXAMINATION GLOVE NON-STERILE POWDEREDSumirubber Industries (Kedah) Sdn. Bhd.·Product code LZA·1999-02-12
K984408 — 130 MODIFIED INTEGRAL FEMORAL COMPONENTBiomet, Inc.·Product code LPH·1999-02-12
K984409 — ELK LASER FILM DIGITIZERNishimoto Sangyo Co., Ltd.·Product code LMA·1999-02-12
K984442 — AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147Hand Biomechanics Lab, Inc.·Product code JEC·1999-02-12
K990005 — SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEMSpinal Concepts, Inc.·Product code KWQ·1999-02-12
K990077 — D-SIGN III (R&D PROJECT DW264#7)Ivoclar North America, Inc.·Product code EJS·1999-02-12
K990078 — D-SIGN IV (R&D PROJECT DW265#37)Ivoclar North America, Inc.·Product code EJS·1999-02-12
K990083 — CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTERSims Deltec, Inc.·Product code FPA·1999-02-12
K990130 — WILSON-COOK PANCREATIC WEDGE STENTWilson-Cook Medical, Inc.·Product code FGE·1999-02-12
K990259 — DISETRONIC MULTIFUSE INFUSION PUMP SYSTEMDisetronic Medical Systems·Product code FRN·1999-02-12
K982003 — DS30 HCY HOMOCYSTEINE ASSAY KITDrew Scientific , Ltd.·Product code LPS·1999-02-11
K982373 — UNI-GOLD STREP A TEST KITTrinity Biotech, Plc·Product code GTY·1999-02-11
K983702 — MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESRoche Diagnostic Systems, Inc.·Product code JXM·1999-02-11
K983836 — RIGID GAS PERMEABLE CONTACT LENS SOLUTIONPolymer Technology Div. Wilmington Partners, L.P.·Product code MRC·1999-02-11
K984058 — ACIST INJECTOR SYSTEM, MODEL CL100 HAcist Medical Systems·Product code IZQ·1999-02-11
K984154 — APF POROUS COATED LINE EXTENSIONBiomet, Inc.·Product code JDI·1999-02-11
K984215 — WELCH ALLYN FRONT-LINE DOCWelch Allyn, Inc.·Product code LLZ·1999-02-11
K984258 — NEUROVASX SUB-MICROINFUSION CATHETERNeuro Vasx, Inc.·Product code DQO·1999-02-11
K984574 — INFINITY GLUCOSE REAGENTSigma Diagnostics, Inc.·Product code CFR·1999-02-11
K990043 — SMOOTHLASE ALEXANDRITE LASER SYSTEMLeisegang Medical, Inc.·Product code GEX·1999-02-11
K990044 — LOBOB UNIVERSAL CONTACT LENS CLEANERLobob Laboratories, Inc.·Product code LPN·1999-02-11
K990098 — VENTLAB VERIFY IIVentlab Corp.·Product code BTR·1999-02-11
K974426 — POTENCY TEST STRIPS, INDICATOR TEST STRIPSReprocessing Products Corp·Product code LIF·1999-02-10
K983054 — MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASERContinuum Biomedical, Inc.·Product code GEX·1999-02-10
K983400 — AUTO SUTURE SITE MARKER CLIPUnited States Surgical, A Division of Tyco Healthc·Product code GDW·1999-02-10
K983704 — MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINERoche Diagnostic Systems, Inc.·Product code JCM·1999-02-10
K984025 — CARE TENSCare Rehab, Inc.·Product code GZJ·1999-02-10
K984030 — VIPERSOFTIntegra Medical·Product code EHD·1999-02-10
K984117 — INNOVA TELESCOPIC DISTRACTORInnova Corp.·Product code MQN·1999-02-10
K984236 — AARON ESU FOOT-CONTROL ADAPTER #A1205AAaron Medical Industries·Product code GEI·1999-02-10
K984239 — SLICKTIP SOLID LAPAROSCOPIC ELECTRODE, MODELS LH01Z, LB02Z, LN03Z, LC04Z, LS05Z, LL06Z, LJ07ZAaron Medical Industries·Product code GEI·1999-02-10
K984262 — MODIFICATION OF BIONECT HYDROGEL GAUZE PADSFidia Pharmaceutical Corp.·Product code MGQ·1999-02-10
K984264 — MODIFICATION OF BIONECT CLEAR HYDROGELFidia Pharmaceutical Corp.·Product code MGQ·1999-02-10
K984266 — MODIFICATION OF BIONECT HYDROGEL SPRAYFidia Pharmaceutical Corp.·Product code MGQ·1999-02-10
K984267 — MODIFICATION OF BIONECT HYDROGEL FOAMFidia Pharmaceutical Corp.·Product code MGQ·1999-02-10
K984276 — DISPOSABLE ELECTROSURGERY GROUNDING PADE & M Engineering, Inc.·Product code GEI·1999-02-10
K984413 — BIONECT HYDROGELFidia Pharmaceutical Corp.·Product code MGQ·1999-02-10
K990088 — SYNTHOFIL NONABSORBABLE PET SURGICAL SUTUREAesculap, Inc.·Product code GAT·1999-02-10
K990127 — CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE (LPGD)Corpak Medsystems·Product code KNT·1999-02-10
K990300 — SUPRASHIELD EXPRESS STERILIZATION WRAPAllegiance Healthcare Corp.·Product code FRG·1999-02-10
K973289 — RE NUPacific Rim Dental, Inc.·Product code EJR·1999-02-09
K981679 — TCM 3000 AND TCM ENDONOUVAG AG·Product code EFB·1999-02-09
K981862 — RESIN 4Harry J. Bosworth Co.·Product code EBI·1999-02-09
K982151 — STERITITE PROCESS INDICATOR ACCESSORIESCase Medical, Inc.·Product code JOJ·1999-02-09
K983106 — 1ST IMPRESSIONDen-Mat Corp.·Product code ELW·1999-02-09
K983411 — COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105Valnet Medical Corp.·Product code FPA·1999-02-09
K983430 — LITE-TOUCH SYRINGEMedicore, Inc.·Product code FMF·1999-02-09
K984063 — PARAGON BASAL/BOLUS ADMINISTRATION SETI-Flow Corp.·Product code FPA·1999-02-09
K984097 — DC-CORES & C Polymer GmbH·Product code EBF·1999-02-09
K984114 — SYS STIM 294, MODEL ME 294Mettler Electronics Corp.·Product code IPF·1999-02-09
K984125 — POWDERED LATEX EXAMINATION GLOVES, NON-STERILEKilang Barangan Getah Dioh·Product code LYY·1999-02-09
K984128 — ENIGMA DENTURE TEETHDavis Schottlander & Davis, Ltd.·Product code ELM·1999-02-09
K984142 — SONICATOR PLUS 992, MODEL NUMBER ME 992 AND SONICATOR PLUS 994, MODEL NUMBER ME 994Mettler Electronics Corp.·Product code IPF·1999-02-09
K984144 — SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACIDAb Biodisk·Product code JWY·1999-02-09
K984146 — PARAGON INFUSIONI-Flow Corp.·Product code FPA·1999-02-09
K984311 — NBR4 MILS NITRILE POWDER FREE EXAMINATION GLOVES NON-STERILESumirubber Industries (Kedah) Sdn. Bhd.·Product code LZA·1999-02-09
K984460 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVESShanghai Huamao Gloves Co., Ltd.·Product code LYZ·1999-02-09
K984461 — PRE-POWDER VINYL PATIENT EXAMINATION GLOVESShanghai Huamao Gloves Co., Ltd.·Product code LYZ·1999-02-09
K984556 — SCICAN CLASSICScholly Fiberoptic GmbH·Product code EIA·1999-02-09

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