FDA 510(k) clearances — page 979

176,637 clearances on record, most recent first.

Clearances — page 979

97,801–97,900 of 176,637

K963681 — CCA-100 (MODIFIED)Benson Medical Instruments Co.·Product code EWO·1996-10-08
K955627 — VIDAS CHLAMYDIA BLOCKING ASSAYBiomerieux Vitek, Inc.·Product code LJC·1996-10-07
K961415 — LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION)Siam Sempermed Corp., Ltd.·Product code LYY·1996-10-07
K961602 — LATEX PATIENT EXAMINATION GLOVE (PINK)Siam Sempermed Corp., Ltd.·Product code LYY·1996-10-07
K962146 — EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KITExcel Scientific, Inc.·Product code GTZ·1996-10-07
K962286 — 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELDBerkley Medical Resources, Inc.·Product code FXX·1996-10-07
K962411 — ONTRAK TESTCUP AMPHETAMINESRoche Diagnostic Systems, Inc.·Product code DKZ·1996-10-07
K962647 — ANGLED ABUTMENTStraumann USA·Product code DZE·1996-10-07
K962667 — CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIRTerumo Medical Corp.·Product code DTZ·1996-10-07
K962709 — SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/Sigma Intl.·Product code FRN·1996-10-07
K962739 — T.B.Q.Convatec, A Division of E.R. Squibb & Sons·Product code LRJ·1996-10-07
K962763 — 2000 MODULAR THIRTY-NINEEqui-Tron Mfg., Inc.·Product code FNL·1996-10-07
K962812 — GLUMA DESENSITIZER/GLUMA 3 PRIMERHeraeus Kulzer, Inc.·Product code KLE·1996-10-07
K962849 — CATHETER INSERTION TRAYMedcare Medical Group, Inc.·Product code LJS·1996-10-07
K962909 — DENTAL PREP WASH AND PREP DISINFECTWilliam J. Day·Product code EBF·1996-10-07
K962956 — MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEMMedi-Ject Corp.·Product code KZE·1996-10-07
K963015 — SURGICAL STAPLE MARKER DEVICE (MODIFY)Biopsys Medical, Inc.·Product code GDW·1996-10-07
K963036 — MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOODBecton Dickinson Microbiology Systems·Product code JTZ·1996-10-07
K963286 — IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENTBeckman Instruments, Inc.·Product code DAD·1996-10-07
K963311 — TEAM ETCHCentrix, Inc.·Product code EBF·1996-10-07
K963427 — IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENTBeckman Instruments, Inc.·Product code DDG·1996-10-07
K963447 — DOUBLE SUPPORT PONCHO/SLIDER PONCHOSkil-Care Corp.·Product code FMQ·1996-10-07
K963448 — ECONO BELTSkil-Care Corp.·Product code FMQ·1996-10-07
K963449 — PELVIC HOLDERSkil-Care Corp.·Product code FMQ·1996-10-07
K963450 — SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VESTSkil-Care Corp.·Product code FMQ·1996-10-07
K963454 — CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELTSkil-Care Corp.·Product code FMQ·1996-10-07
K963551 — BIO-CSF LIQUID CONTROL LEVEL 1 AND 2Biocell Laboratories, Inc.·Product code JJX·1996-10-07
K963583 — MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLEMedimop Medical Projects, Ltd.·Product code LHI·1996-10-07
K955685 — RNS STERILE, DISPOSABLE CT BIOPSY TRAYContour Fabricators of Florida, Inc.·Product code DXT·1996-10-04
K961664 — COMPAT NASOJEJUNAL FEEDING TUBESandoz Nutrition·Product code KNT·1996-10-04
K961821 — ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSORAspect Medical Systems, Inc.·Product code GXY·1996-10-04
K962173 — SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIESMallinckrodt Medical·Product code JOH·1996-10-04
K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)Customed, Inc.·Product code KNX·1996-10-04
K962663 — SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SETSolopak Medical Products, Inc.·Product code MEB·1996-10-04
K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.·Product code FGO·1996-10-04
K962681 — ECOGEL 300 TENS GELEco-Med Pharmaceuticals, Inc.·Product code GYB·1996-10-04
K962897 — EG-3400, VIDEO GASTROSCOPEPentax Precision Instrument Corp.·Product code FDS·1996-10-04
K963355 — SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SETSolopak Medical Products, Inc.·Product code MEB·1996-10-04
K963377 — EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPECNorth Eos Industries, Inc.·Product code HIB·1996-10-04
K954490 — MERCURY MEDICAL CPR BAG EXHALATION FILTERMercury Medical·Product code CAH·1996-10-03
K955596 — N LATEX B2-MICROGLOBULIN REAGENTBehring Diagnostics, Inc.·Product code JZG·1996-10-03
K960425 — BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXXEndotec, Inc.·Product code JDI·1996-10-03
K961091 — KARL STORZ MODEL 203020 20 EQUIMATKARL STORZ Endoscopy-America, Inc.·Product code HIG·1996-10-03
K961094 — MITEK THREADED ANCHOR (MODIFICATION)Mitek Products·Product code MBI·1996-10-03
K962233 — TWIST-OFF SCREWLandos, Inc.·Product code HWC·1996-10-03
K962624 — RESOLUT REGENERATIVE MATERIALW. L. Gore & Associates, Inc.·Product code LYC·1996-10-03
K962639 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTImpra, Inc.·Product code DSY·1996-10-03
K962769 — HORIZON HIP SYSTEMBiologically Oriented Prostheses·Product code LPH·1996-10-03
K962824 — IMPLANTECH JEJ PERI-PYRIFORM IMPLANTImplantech Associates, Inc.·Product code FZE·1996-10-03
K944036 — STERIMASTER AUTOCLAVEScican·Product code FLE·1996-10-02
K953983 — EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUERichard Wolf Medical Instruments Corp.·Product code FAS·1996-10-02
K955827 — DANESHVAR WOUND SUPPORT UNITY. Daneshvar·Product code DXC·1996-10-02
K960188 — PRESSUREGUARD: SELECTCARESpan-America Medical Systems, Inc.·Product code FNM·1996-10-02
K960272 — EAGLE 3000/3100 PATIENT MONITORMarquette Electronics, Inc.·Product code MLD·1996-10-02
K960418 — EAGLE PATIENT MONITORMarquette Electronics, Inc.·Product code DSI·1996-10-02
K960811 — PHACOSCOPESaint John'S Plaza Medical Group·Product code HQC·1996-10-02
K961000 — CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIRTerumo Medical Corp.·Product code DTZ·1996-10-02
K962278 — SUPERSTAND STAND-UP WHELLCHAIRThe Standing Co., Inc.·Product code IPL·1996-10-02
K962626 — PATIENT PROTECTIVE LIMBKenad SG Medical, Inc.·Product code FMQ·1996-10-02
K962745 — ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)Prepared Media Laboratory, Inc.·Product code JSN·1996-10-02
K962784 — ULTIUM SPINAL PLATING SYSTEMSmith & Nephew, Inc., Orthopaedic Div.·Product code MNH·1996-10-02
K962837 — NULIFEMed-Tech Rubber & Engineering Industries·Product code KGO·1996-10-02
K963113 — FLEXIFLO POLYG GASTOSTOMY TUBEAbbott Laboratories·Product code KNT·1996-10-02
K963185 — ELECTRONIC X-RAY TIMER 1400A, 1400AW AND UNIVERSAL DIGITAL DENTAL X-RAY TIMERElectronic Control Concepts·Product code EHD·1996-10-02
K963200 — QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEMWrightmedicaltechnologyinc·Product code MBI·1996-10-02
K963217 — ANCHORLOK II SOFT TISSUE ANCHOR SYSTEMWrightmedicaltechnologyinc·Product code MBI·1996-10-02
K955807 — COTREL-DUBOUSSET (CD) SPINALSofamor Danek USA,Inc.·Product code KWP·1996-10-01
K955846 — MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETERY·Product code FLL·1996-10-01
K960633 — PRESS-FIT FLARED SHELLEncore Orthopedics, Inc.·Product code LWJ·1996-10-01
K961107 — B. BRAUN GUIDEWIRESB.Braun Medical, Inc.·Product code DQX·1996-10-01
K961299 — PRECISION UV (VASURFILCON A)Pilkington Barnes-Hind, Ltd.·Product code LPL·1996-10-01
K961304 — AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEMExactech, Inc.·Product code JDI·1996-10-01
K961943 — FLEXLENSFlexlens, Inc.·Product code LPL·1996-10-01
K962000 — FLEXLENS(METHAFILCON A)Flexlens, Inc.·Product code LPL·1996-10-01
K962622 — INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.·Product code KPY·1996-10-01
K962695 — PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETERSims Deltec, Inc.·Product code LJT·1996-10-01
K962705 — MLI MODULAR STAPLEMedicinelodge, Inc.·Product code JDR·1996-10-01
K962721 — EVIDENCE PREGNANCY TESTSaliva Diagnostic Systems·Product code LCX·1996-10-01
K962793 — MITEK MICRO ANCHORMitek Products·Product code JDR·1996-10-01
K962804 — ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKERVistakon, Johnson & Johnson Vision Products, Inc.·Product code LPL·1996-10-01
K962823 — SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHERSynthes (Usa)·Product code HWC·1996-10-01
K962923 — DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)Depuy, Inc.·Product code LPH·1996-10-01
K962957 — RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINTWesley Jessen Corp.·Product code LPL·1996-10-01
K963028 — TIBIAL INSERTEncore Orthopedics, Inc.·Product code JWH·1996-10-01
K963040 — MANUAL PHENYLALANINE TESTBio-Rad·Product code JNB·1996-10-01
K963058 — INFANT WARMER SYSTEMOhmeda Medical·Product code FMT·1996-10-01
K963077 — TBDAcu Med, Inc.·Product code HSB·1996-10-01
K963155 — INTERMOORE FRACTURE HIP STEM (MODIFY)Intermedics Orthopedics·Product code LWJ·1996-10-01
K963243 — HEELBO BLAZER SLEEVED JACKETHeelbo, Inc.·Product code FMQ·1996-10-01
K963585 — BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000Diagnostic Ultrasound Corp.·Product code IYO·1996-10-01
K923880 — ORLAU SWIVEL WALKERMopac, Ltd.·Product code MRI·1996-09-30
K953930 — VIRTUOSO SMART CPAP SYSTEMRespironics, Inc.·Product code BZD·1996-09-30
K960055 — MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932Pudenz-Schulte Medical Research Corp.·Product code LJS·1996-09-30
K960301 — ND VISION-220 ADAPTIVE IMAGE PROCESSESSORDel Medical Systems Corp.·Product code GCJ·1996-09-30
K962090 — KARL STORZ MODEL 203210 O1 UNIMAT PLUSKARL STORZ Endoscopy-America, Inc.·Product code HET·1996-09-30
K962360 — IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIESScimedx Corp.·Product code MOB·1996-09-30
K962651 — S-52 ELECTRONIC VIDEO LAPAROSCOPEDel Medical Systems Corp.·Product code GCJ·1996-09-30
K962680 — HYUNJAE DENTAL IMPRESSION MATERIALSHyunjae Corp.·Product code ELW·1996-09-30
K962747 — PULPDENT ENDODONTIC POST CEMENT KITPulpdent Corp.·Product code EMA·1996-09-30
K962751 — IDEAS' DUAL PORTIdeas For Medicine, Inc.·Product code LJT·1996-09-30

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