FDA 510(k) clearances — page 980

176,637 clearances on record, most recent first.

Clearances — page 980

97,901–98,000 of 176,637

K962858 — HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEMHeartport, Inc.·Product code DXC·1996-09-30
K962867 — SENSITITRE 18 HOUR SUSCEPTIBILITY PLATESSensititre Alamar·Product code JWY·1996-09-30
K963291 — VARELISA ANA (4) PROFILEElias U.S.A., Inc.·Product code LJM·1996-09-30
K963299 — HWA-TO ACUPUNCTURE NEEDLESLhasa Medical, Inc.·Product code MQX·1996-09-30
K963534 — SIGMA DIAGNOSTICS CREATININE REAGENT KITSigma Diagnostics, Inc.·Product code CGX·1996-09-30
K950264 — MAGLIFEOdam·Product code MHX·1996-09-27
K953044 — UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATIONBiotronik, Inc.·Product code DTB·1996-09-27
K960964 — OHMEDA 7900 ANESTHESIA VENTILATOROhmeda Medical·Product code CBK·1996-09-27
K961674 — ROCHE UNIMATE FRUCTOSAMINE REAGENTRoche Diagnostic Systems, Inc.·Product code LCP·1996-09-27
K961815 — QUALITROL ANA CONTROL SERUM SETConsolidated Technologies, Inc.·Product code LKJ·1996-09-27
K962033 — CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KITNichols Institute Diagnostics·Product code CEW·1996-09-27
K962596 — CUSTOMED BLOOD EXTRACTION KITCustomed, Inc.·Product code GJE·1996-09-27
K962613 — DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEMGulmay Medical , Ltd.·Product code JAD·1996-09-27
K962890 — CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)Trace Scientific , Ltd.·Product code CHH·1996-09-27
K963037 — PATRIOTInfimed, Inc.·Product code LLZ·1996-09-27
K963066 — MENTOR INJECTION PORT DETECTOR (IPD)Mentor Corp.·Product code LCJ·1996-09-27
K963080 — TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)Bayer Corp.·Product code CDZ·1996-09-27
K963142 — DCA 2000 + MICROALBUMIN/CREATININE ASSAYBayer Corp.·Product code JIR·1996-09-27
K963261 — EBI THERMAL THERAPY SYSTEMElectro-Biology, Inc.·Product code ILO·1996-09-27
K963519 — EUROLINE A-675 SERISStarkey Laboratories, Inc.·Product code ESD·1996-09-27
K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFERSigma Diagnostics, Inc.·Product code JFL·1996-09-27
K963542 — SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENTSigma Diagnostics, Inc.·Product code JGS·1996-09-27
K963604 — DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSIONMidwest City Hearing Aid Center·Product code ESD·1996-09-27
K960902 — EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03Eureduc·Product code JOW·1996-09-26
K962198 — QUANTEX C4Instrumentation Laboratory CO·Product code DBI·1996-09-26
K962202 — QUANTEX IGGInstrumentation Laboratory CO·Product code DEW·1996-09-26
K963508 — DISPENS-O-DISC MEROPENEMDifco Laboratories, Inc.·Product code JTN·1996-09-26
K952975 — ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.·Product code BXB·1996-09-25
K953567 — INCSTAR 25-HYDROXYVITMIN D 1251 RIAIncstar Corp.·Product code MRG·1996-09-25
K961382 — MT1AThe Emerging Technologies Group·Product code DZE·1996-09-25
K961383 — MT1The Emerging Technologies Group·Product code DZE·1996-09-25
K961384 — MT-2The Emerging Technologies Group·Product code DZE·1996-09-25
K961385 — MT-3AThe Emerging Technologies Group·Product code DZE·1996-09-25
K961386 — MT-2AThe Emerging Technologies Group·Product code DZE·1996-09-25
K961387 — MT-XThe Emerging Technologies Group·Product code DZE·1996-09-25
K961771 — AUTO SUTURE SURGIWANDUnited States Surgical, A Division of Tyco Healthc·Product code GEI·1996-09-25
K962199 — QUANTEX C3Instrumentation Laboratory CO·Product code CZW·1996-09-25
K962200 — QUANTEX IGAInstrumentation Laboratory CO·Product code CZP·1996-09-25
K962201 — QUANTEX IGMInstrumentation Laboratory CO·Product code DFT·1996-09-25
K962552 — EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEMBiodynamic Technologies, Inc.·Product code HSB·1996-09-25
K962561 — SUPRACONDYLAR INTRAMEDULLARY NAILZimmer, Inc.·Product code HSB·1996-09-25
K962757 — J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMPJ.B.S., S.A.·Product code MNH·1996-09-25
K962878 — TARGIS SYSTEMIvoclar North America, Inc.·Product code EBF·1996-09-25
K962927 — IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMSSiemens Medical Solutions USA, Inc.·Product code LNH·1996-09-25
K962979 — S-53 INTRORAL DENTAL SYSTEMDel Medical Systems Corp.·Product code DZA·1996-09-25
K954045 — AXSYM RUBELLA IGG ANTIBODY ASSAYAbbott Laboratories·Product code LFX·1996-09-24
K960337 — AMD HOME HEALTH MONITORING SYSTEMAdvanced Medical Devices, Inc.·Product code CGA·1996-09-24
K961312 — HEMOCUE B-HEMOGLOBIN SYSTEMHemocue, Inc.·Product code GKR·1996-09-24
K961544 — QUALITROL IGAME CONTROLS, LEVELS 1 AND 2Consolidated Technologies, Inc.·Product code DGR·1996-09-24
K961545 — QUALITROL RF CONTROLSConsolidated Technologies, Inc.·Product code DHR·1996-09-24
K961550 — QUALITROL MONO CONTROL SERUM SETConsolidated Technologies, Inc.·Product code KTN·1996-09-24
K962542 — AIR MOTOR HANDPIECE TN-102Nsk Nakanishi, Inc.·Product code EFB·1996-09-24
K963359 — INSUFFLATION NEEDLEApplied Medical Resources·Product code HET·1996-09-24
K953823 — ARTERIAL VENOUS BLOOD TUBING SETMedisystems Corp.·Product code FJK·1996-09-23
K954728 — PROD NO. 01-1694 - 4X4 FOAM DRESSINGContinental Medical Laboratories, Inc.·Product code KMF·1996-09-23
K961356 — MAMMARY SIZERGeneral Surgical Innovations·Product code MRD·1996-09-23
K961522 — KIRSCHNER WIRE (K-WIRE) AND STEINMANN PINSynvasive Technology, Inc.·Product code HTY·1996-09-23
K961826 — DIGIPANTrophy Radiologie·Product code EHD·1996-09-23
K962043 — AUTO SUTURE MODIFIED VCS CLIP APPLIERUnited States Surgical, A Division of Tyco Healthc·Product code FZP·1996-09-23
K962462 — MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATORSmith and Nephew Donjoy, Inc.·Product code IPF·1996-09-23
K962592 — OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMSAlcon Laboratories·Product code GEX·1996-09-23
K962646 — PRIME MODULAR ENDO HEADOrthopaedic Innovations, Inc.·Product code KWL·1996-09-23
K962888 — AFFIRM ONE-STEP HOME PREGNANCY TESTAthena Medical Corp.·Product code LCX·1996-09-23
K963039 — SURESKIN STANDARD, BORDER, AND THINEuromed A/S·Product code FRO·1996-09-23
K963175 — GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLINGGlycar, Inc.·Product code FTM·1996-09-23
K963244 — ACETAMINOPHEN FLEX REAGENT CARTRIDGEDade Intl., Inc.·Product code LDP·1996-09-23
K963246 — TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOTMedtronic Xomed·Product code ERL·1996-09-23
K963300 — DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES)Lhasa Medical, Inc.·Product code MQX·1996-09-23
K963383 — HICHEM ALP/AMP REAGENT KITHichem Diagnostics·Product code CKF·1996-09-23
K953943 — AXSYM CMV IGG ANTIBODY ASSAYAbbott Laboratories·Product code LFZ·1996-09-20
K955547 — CHIPS STANDUP WHEELCHAIRInternational Healthcare Solutions, Inc.·Product code ITI·1996-09-20
K955548 — CHIPS POWERED WHEELCHAIRInternational Healthcare Solutions, Inc.·Product code ITI·1996-09-20
K955577 — ECLIPSE VERSION 3.0Stellate Systems·Product code OLT·1996-09-20
K960024 — STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCHStorz Instrument Co.·Product code HQC·1996-09-20
K960078 — ASTHMA MONITORErich Jaeger, Inc.·Product code BZG·1996-09-20
K960087 — SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)Wrightmedicaltechnologyinc·Product code JDB·1996-09-20
K960865 — STEP OPTION TO PRISM 2000Philips Medical Systems (Cleveland), Inc.·Product code KPS·1996-09-20
K961140 — FLUOROPLUS CARDIAC TVCmt Medical Technologies, Ltd.·Product code JAA·1996-09-20
K961580 — PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCESS SYTEMSSims Deltec, Inc.·Product code LJT·1996-09-20
K962236 — SCARF THREAD-HEAD SCREWLandos, Inc.·Product code HWC·1996-09-20
K962427 — COBE CENTRYSYSTEM 700 HG HEMODIALYZERGambro Healthcare·Product code KDI·1996-09-20
K962465 — TIL313 ABUTMENT AND RETAINING SCREW SYSTEMSImplant Innovations, Inc.·Product code DZE·1996-09-20
K962494 — PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATEUsbiomaterials Corp.·Product code LYC·1996-09-20
K962503 — GUGLIELMI DETACHABLE COILTarget Therapeutics·Product code HCG·1996-09-20
K962544 — MICRO DIAMOND-POINT DISSECTION NEEDLESDsp Worldwide·Product code JOS·1996-09-20
K962589 — AURORA DIAGNOSTIC WORKSTATIONAurora Technology, Inc.·Product code LLZ·1996-09-20
K962590 — SIGNALDRESSConvatec, A Division of E.R. Squibb & Sons·Product code FRO·1996-09-20
K962677 — ESTEEM 1.5T MRI SYSTEMElscint Mr, Inc.·Product code LNH·1996-09-20
K962806 — OHMEDA-OHIO CAE PLUS INCUBATOROhmeda Medical·Product code FMZ·1996-09-20
K962896 — KODAK DIGITAL SCIENCE REMOTE CASSETTEEastman Kodak Company·Product code KPR·1996-09-20
K962986 — MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVESJohnson & Johnson Medical, Inc.·Product code KGO·1996-09-20
K963006 — SCION SAPHENOUS VEIN HARVESTING SYSTEMScion International, Inc.·Product code GAD·1996-09-20
K963043 — ENDOSPOTCorin USA·Product code FCW·1996-09-20
K963044 — ENDOBEAMCorin USA·Product code GCT·1996-09-20
K963252 — TBANBoston Scientific Corp·Product code EOQ·1996-09-20
K963607 — HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANALMidwest City Hearing Aid Center·Product code ESD·1996-09-20
K960674 — CONTRAST INJECTION LINESB.Braun Medical, Inc.·Product code DXT·1996-09-19
K961716 — VASO-SAFE ARTERIAL EMBOLECTOMY CATHETEIdeas For Medicine, Inc.·Product code DXE·1996-09-19
K962216 — TSH (MICROWELL) ELISABiomerica, Inc.·Product code JLW·1996-09-19
K962402 — AMO PRESTIGE DAY PACK (ALLERGAN, INC.)Allergan, Inc.·Product code HQC·1996-09-19

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