FDA 510(k) clearances — page 1403

176,637 clearances on record, most recent first.

Clearances — page 1403

140,201–140,300 of 176,637

K872634 — CUTTER PUREFLO PLUS IV FILTERMiles Laboratories, Inc.·Product code FPB·1987-08-04
K872648 — SOLAR GOLD UVA SUN TANNING BEDAn-Mar International, Ltd.·Product code FTC·1987-08-04
K872657 — ULTRAPAC II SX PLUS (TM)Medical Devices, Inc.·Product code GZJ·1987-08-04
K872735 — HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.Howmedica Corp.·Product code HSX·1987-08-04
K872787 — MODIFIED CURLCATHQuinton, Inc.·Product code GBQ·1987-08-04
K872797 — NON-SKID SHOE COVERSAbco Dealers, Inc.·Product code FXP·1987-08-04
K872806 — STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNGAmerican Silk Sutures, Inc.·Product code EFQ·1987-08-04
K872807 — NON-WOVEN TRACHEOTOMY SPONGEAmerican Silk Sutures, Inc.·Product code GDY·1987-08-04
K872808 — CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8American Silk Sutures, Inc.·Product code EFQ·1987-08-04
K872809 — GAUZE CHERRY SPONGEAmerican Silk Sutures, Inc.·Product code GDY·1987-08-04
K872940 — FOLDING WHEELCHAIRHealth Care Innovations, Inc.·Product code IOR·1987-08-04
K870859 — BAG-TAIL BLEED VALVEDryden Corp.·Product code CAI·1987-08-03
K871441 — ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODENitto Denko America, Inc.·Product code DRX·1987-08-03
K871774 — CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETSGish Biomedical, Inc.·Product code DTR·1987-08-03
K871776 — WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SYDow Corning Wright·Product code JWH·1987-08-03
K871816 — STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TMStryker Corp.·Product code EAY·1987-08-03
K871844 — ARGYLE VASCULAR BYPASS SETSherwood Medical Co.·Product code DWF·1987-08-03
K872153 — STOM-VENTGibeck Respiration·Product code BYD·1987-08-03
K872154 — MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATHIdeas For Medicine, Inc.·Product code DQT·1987-08-03
K872283 — ORAL SUCTION CATHETERBallard Medical Products·Product code BSY·1987-08-03
K872470 — DEVO/MC44 OXYGEN CONCENTRATORThe Devilbiss Co.·Product code CAW·1987-08-03
K872519 — STERILIZED OMNI GELEcho Ultrasound·Product code JOT·1987-08-03
K872552 — HEARING-AIDAudio-Technica U.S., Inc.·Product code ESD·1987-08-03
K872598 — MICROMI-CK(TM)Intl. Immunoassay Laboratories, Inc.·Product code JHT·1987-08-03
K872890 — SYNERGYScientific Pharmaceuticals, Inc.·Product code EBF·1987-08-03
K872907 — DENTIN ADHESIVEDentsply Intl.·Product code EBF·1987-08-03
K870995 — SCALP VEIN SETMac Lee Medical Products·Product code FPA·1987-07-31
K871146 — GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)Richards Medical Co., Inc.·Product code JWH·1987-07-31
K871746 — CAPTIA(R) TOXO-M: AN ENZYME IMMUNOASSAYMercia Diagnostics , Ltd.·Product code LGD·1987-07-31
K871834 — DRILL, HAND, BONE, SMEDBERGMilitary Engineering, Inc.·Product code DZJ·1987-07-31
K871887 — ANCHOR IIA/2 STAGE OSSEO. TIT. 6/4 ALLOY IMPLANTAnchor Implants , Ltd.·Product code DZE·1987-07-31
K871929 — PROBRIGHT TOOTH POLISHERLap Investments, Inc.·Product code JEQ·1987-07-31
K871953 — TEMPORARY BRIDGE HEADImplant Innovations International, Inc.·Product code DZE·1987-07-31
K871954 — ABUTMENT HEAD POSTImplant Innovations International, Inc.·Product code DZE·1987-07-31
K871955 — TEMPORARY SCREWImplant Innovations International, Inc.·Product code DZE·1987-07-31
K872028 — BIRDIE BRACKETWilliam W. Wilkerson & Gregory A. Knutson·Product code ISA·1987-07-31
K872082 — RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDEMedical Diagnostic Technologies, Inc.·Product code LKT·1987-07-31
K872091 — CURRETTES, ALVEOLAR (MOLT AND MILLER)Military Engineering, Inc.·Product code EMS·1987-07-31
K872098 — CREMEEN ALVEOLAR BONE CALIPERBowen & Company, Inc.·Product code EIL·1987-07-31
K872196 — AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & IIIAmerican Dade·Product code JJS·1987-07-31
K872217 — THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KITPacific Hemostasis·Product code GHM·1987-07-31
K872309 — MICROMEDIC COMBOSTAT LH/FSH KITMicromedic Systems·Product code CGJ·1987-07-31
K872348 — HEARING AIDAssured Sound Laboratories, Inc.·Product code ESD·1987-07-31
K872372 — BEHIND-THE-EAR HEARING AID OTICON E40Oticon Corp.·Product code ESD·1987-07-31
K872374 — WIDEX HEARING AID MODEL ES1Widex Hearing Aid Co., Inc.·Product code ESD·1987-07-31
K872551 — SEAMED MODEL 3200Seamed Corp.·Product code DTE·1987-07-31
K872592 — IMACK-MB(TM)Intl. Immunoassay Laboratories, Inc.·Product code JHT·1987-07-31
K872610 — SOLOS EYESITE CANNULASSolos Ophthalmology·Product code HMX·1987-07-31
K872612 — SOLOS EYESITE SPONGESSolos Ophthalmology·Product code HOZ·1987-07-31
K872620 — SOLOS EYESITE DRAPESSolos Ophthalmology·Product code HMT·1987-07-31
K872716 — CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULECiba Corning Diagnostics Corp.·Product code JGS·1987-07-31
K872758 — THEATRE GOWNSSmith & Nephew, Inc.·Product code FYA·1987-07-31
K872792 — WATERS M600E MULTI-SOLVENT DELIVERY SYSTEMMillipore Corp.·1987-07-31
K872868 — ASPEN ESMARK BANDAGEAspen Laboratories, Inc.·Product code FQM·1987-07-31
K872897 — TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.Serono Diagnostics, Inc.·Product code JLW·1987-07-31
K870817 — MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORTC.R. Bard, Inc.·Product code LJT·1987-07-30
K871795 — RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.Gen-Probe, Inc.·Product code LQF·1987-07-30
K871905 — TOXOPLASMA GONDII IGG ELISAElectro-Nucleonics Laboratories, Inc.·Product code LGD·1987-07-30
K872738 — CORTICAL BONE SCREWSMilitary Engineering, Inc.·Product code HWC·1987-07-30
K872739 — SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHIOND.A. Schulman, Inc.·Product code KIC·1987-07-30
K871418 — VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)Critikon Company, LLC·Product code DXN·1987-07-29
K871720 — MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETERA&D Engineering, Inc.·Product code DSK·1987-07-29
K871886 — MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONITDraeger Medical, Inc.·Product code DXN·1987-07-29
K872144 — MODIFIED DIGITAL BLOOD PRESSURE/PULSE METERVestra-Subco, Inc.·Product code DXQ·1987-07-29
K872184 — TB METHYLENE BLUERemel Co.·Product code JTS·1987-07-29
K872185 — LIGHT GREENRemel Co.·Product code JTS·1987-07-29
K872186 — SULFURIC ACID 10%Remel Co.·Product code JTS·1987-07-29
K872187 — TB KINYOUN CARBOLFUCHSINRemel Co.·Product code JTS·1987-07-29
K872189 — METHANOL, ABSOLUTERemel Co.·Product code JTS·1987-07-29
K872229 — VITEL III, ECG TRANSMITTEREquimed Corp.·Product code DSH·1987-07-29
K872398 — T.E.N.S. DEVICE MODEL SPL 2000Spartan Laboratories, Inc.·Product code GZJ·1987-07-29
K872624 — INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSINGSmith & Nephew, Inc.·Product code FRO·1987-07-29
K871619 — LPM-1 (LASER POWER METER)Bio-Tek Instruments, Inc.·Product code GEX·1987-07-28
K871679 — FOCUS-GHBAwareness Technology, Inc.·Product code LCP·1987-07-28
K871879 — SOFSWABPlastic Engineered Products Co.·Product code EFW·1987-07-28
K872375 — WIDEX HEARING AID MODEL ES6Widex Hearing Aid Co., Inc.·Product code ESD·1987-07-28
K872473 — POST-AURICULAR HEARING AID MODEL PE 805CD2Phonic Ear, Inc.·Product code ESD·1987-07-28
K872474 — POST-AURICULAR HEARING AID MODEL PE 805 SCD2Phonic Ear, Inc.·Product code ESD·1987-07-28
K872518 — REM500 THREE WHEELED ELEC. CART.Royal Enterprises Manufacturing, Inc.·Product code INI·1987-07-28
K872597 — FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATEDianon Systems, Inc.·Product code DWO·1987-07-28
K872757 — OPSITE SPECIALITY DRAPESSmith & Nephew, Inc.·Product code KKX·1987-07-28
K864544 — DIABETES RISK DETECTORPearce Clinical Laboratories, Inc.·Product code JIL·1987-07-27
K871726 — OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)Monoclonal Antibodies, Inc.·Product code CEP·1987-07-27
K871728 — MODIFIED LIFECARE(R) 4100 PCA INFUSERAbbott Laboratories·Product code FRN·1987-07-27
K871854 — IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERSCooperVision, Inc.·Product code HQC·1987-07-27
K871908 — IV ADMINISTRATION SETTravenol Laboratories, S.A.·Product code BRZ·1987-07-27
K872320 — EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616Em Diagnostic Systems, Inc.·Product code JQB·1987-07-27
K872322 — EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95Em Diagnostic Systems, Inc.·Product code JQB·1987-07-27
K872362 — FRIGITRONICS ACC-1000 CAPSULE CUTTERFrigitronics of Connecticut, Inc.·Product code HQC·1987-07-27
K872399 — T.E.N.S. DEVICE MODEL SPL 2000SSpartan Laboratories, Inc.·Product code GZJ·1987-07-27
K872503 — FH LENFu Heng First Industrial Co., Ltd.·Product code HQY·1987-07-27
K872506 — MELANITE IAura Lens Products·Product code HQG·1987-07-27
K872584 — FORTEC MI-306, MI-327 DIGITAL THERMOMETERNam Tai , Ltd.·Product code FLL·1987-07-27
K872649 — HAND/FOOT UVA/UVB 624-224National Biological Corp.·Product code FTC·1987-07-27
K872650 — PANOSOL 2000 624-604National Biological Corp.·Product code FTC·1987-07-27
K872651 — PANOSOL 2000 624-414National Biological Corp.·Product code FTC·1987-07-27
K872659 — TAPELESS EYE SHIELDPrecision Therapeutics, Inc.·Product code HOY·1987-07-27
K872706 — PANOSOL 2000 624-616National Biological Corp.·Product code FTC·1987-07-27
K872707 — PANOSOL 2000 624-404National Biological Corp.·Product code FTC·1987-07-27
K872783 — AMPICILLIN/SULBACTAM 20 MCG SENSI-DISCBd Becton Dickinson Vacutainer Systems Preanalytic·Product code JTN·1987-07-27

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