FDA 510(k) clearances — page 895

176,637 clearances on record, most recent first.

Clearances — page 895

89,401–89,500 of 176,637

K983246 — POS-T-VAC (IVP-600)Pos-T-Vac, Inc.·Product code LKY·1998-11-02
K983619 — BARCHENS COMPANY DIGITAL PACIFIER THERMOMETERBarchens Co.·Product code FLL·1998-11-02
K973985 — AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)Datex-Engstrom, Inc.·Product code BSZ·1998-10-30
K981034 — SILENT NIGHT IISleep Solutions, Inc.·Product code MNR·1998-10-30
K981366 — STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIESSensor Medics Corp.·Product code BTY·1998-10-30
K981371 — LTV 1000 VENTILATORPulmonetic Systems, Inc.·Product code CBK·1998-10-30
K982766 — PASTE OPAQUE EX-3Noritake Co., Inc.·Product code EIH·1998-10-30
K983067 — FINE-JECTHenke Sass Wolf of America, Inc.·Product code FMI·1998-10-30
K983122 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KITMill-Rose Laboratory·Product code EOQ·1998-10-30
K983124 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KITMill-Rose Laboratory·Product code EOQ·1998-10-30
K983207 — SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVESShijiazhuang Great Eagle Plastic Products Co., Ltd.·Product code LYZ·1998-10-30
K981096 — SEMPERMED SURGEONS' GLOVES - SUPREMESemperit Technische Produkte Gesellshaft·Product code KGO·1998-10-29
K981497 — STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GASSteritec Products Mfg Co, Inc.·Product code FRC·1998-10-29
K981508 — VECTORVISION SPINE MODULEBrainlab AG·Product code HAW·1998-10-29
K982131 — NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVEAnsell Edmont Industrial, Inc.·Product code LZA·1998-10-29
K982673 — JUST BETWEEN US, PERSONAL LUBRICANT & CONDOMKey West Fragrance & Cosmetic·Product code HIS·1998-10-29
K982675 — AIRWATCH II ZONELESSEnact Health Management Systems·Product code BZH·1998-10-29
K982676 — AIRWATCH II ZONEEnact Health Management Systems·Product code BZH·1998-10-29
K982789 — MEDICAL AIR COMPRESSOR, MODEL # 8413419Drager, Inc.·Product code BTI·1998-10-29
K982824 — X-RAY TIMER MODEL I.E.D. 7888 I.D. 7881 AND B764IDI.E.D., Inc.·Product code KPR·1998-10-29
K982834 — RESTGRID PACKAGE/GYROSCAN NTPhilips Medical Systems North America, Inc.·Product code LNH·1998-10-29
K982835 — ELECTRODE SWITCHBOX, MODEL 11-081002Cardima, Inc.·Product code DRF·1998-10-29
K982916 — MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHCMedrad, Inc.·Product code MOS·1998-10-29
K983273 — XCT 2000 L PQCT BONE DENSITOMETERMedical Systems, Inc.·Product code KGI·1998-10-29
K983436 — GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEMGammamed USA·Product code JAQ·1998-10-29
K983447 — WISE (II) IMAGE MANAGEMENT SYSTEMSectra-Imtec AB·Product code LMB·1998-10-29
K983643 — GENESIS BLSO-Two Systems Intl., Inc.·Product code BTL·1998-10-29
K983705 — EMT RESUSCITATORO-Two Systems Intl., Inc.·Product code BTL·1998-10-29
K983785 — AUTOVENT 1000O-Two Systems Intl., Inc.·Product code BTL·1998-10-29
K973138 — SPIROCARDQrs Diagnostic, LLC·Product code BZG·1998-10-28
K974581 — MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENTInvivo Research, Inc.·Product code DRT·1998-10-28
K980799 — HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIALCosmedent, Inc.·Product code EBG·1998-10-28
K981207 — CLEARPLAN EASY FERTILITY MONITORUnipath , Ltd.·Product code NGE·1998-10-28
K981528 — SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEMSiemens Medical Solutions USA, Inc.·Product code IYO·1998-10-28
K982082 — HANDISOL WOUND HEALINGNational Biological Corp.·Product code FTC·1998-10-28
K982225 — SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504Spiracle Technology·Product code BTL·1998-10-28
K982541 — VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608Becton Dickinson Vacutainer Systems·Product code FMI·1998-10-28
K982662 — DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREWDePuy Orthopaedics, Inc.·Product code HWC·1998-10-28
K982693 — MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNSMedline Industries, Inc.·Product code FYA·1998-10-28
K982723 — MAICO MA42Bernafon-Maico, Inc.·Product code EWO·1998-10-28
K982733 — OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USEThe Olympus Optical Co.·Product code ITX·1998-10-28
K982793 — PIEZO TRONICAdvanced Medical Devices, Inc.·Product code ELC·1998-10-28
K982810 — SHELHIGH NO-REACT VASCUPATCHShelhigh, Inc.·Product code DXZ·1998-10-28
K982970 — MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETERMri Manufacturing and Research, Inc.·Product code EZL·1998-10-28
K983080 — AUROLLOYD KFBego U.S.A.·Product code EJT·1998-10-28
K983081 — BEGOPAL 300Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO·Product code EJS·1998-10-28
K983082 — BEGOCER GBego U.S.A.·Product code EJT·1998-10-28
K983091 — ELAN-2Kerr Dental Materials Center·Product code EBF·1998-10-28
K983184 — MEPILEXMolnlycke Health Care, Inc.·Product code MGP·1998-10-28
K983709 — SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1Beckman Coulter, Inc.·Product code DIF·1998-10-28
K980977 — PIOLAX HYDROPHILIC GUIDEWIREPiolax Medical Devices, Inc.·Product code DQX·1998-10-27
K982948 — ELECSYS PSA, MODEL # ELECSYS 1010Boehringer Mannheim Corp.·Product code LTJ·1998-10-27
K982949 — ELECSYS PSA, MODEL 2010Boehringer Mannheim Corp.·Product code LTJ·1998-10-27
K983014 — SUMMIT ACETABULAR SYSTEMJohnson & Johnson Professionals, Inc.·Product code LPH·1998-10-27
K983339 — OSTEO DYNATROC PROXIMAL FEMORAL NAILOsteonics Corp.·Product code HSB·1998-10-27
K983510 — CHEMSTRIP 101 URINE ANALYZERBoehringer Mannheim Corp.·Product code KQO·1998-10-27
K983548 — FERRITIN CALIBRATORDade Behring, Inc.·Product code JIT·1998-10-27
K981613 — COBE SMARXT TUBING AND CONNECTORSCobe Cardiovascular, Inc.·Product code DWE·1998-10-26
K982624 — MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242Med-Tec,Inc.·Product code IYE·1998-10-26
K982636 — PATIENT WARMER- MODEL PW810Fisher & Paykel Healthcare, Ltd.·Product code ILY·1998-10-26
K982890 — ADVANCED UROSCIENCE INJECTION NEEDLEAdvanced Uroscience, Inc.·Product code FBK·1998-10-26
K982892 — 3M TEGASORB THIN HYDROCOLLOID DRESSING3M Company·Product code KMF·1998-10-26
K982893 — 3M TEGASORB HYDROCOLLOID DRESSING3M Company·Product code KMF·1998-10-26
K983197 — SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)United States Surgical, A Division of Tyco Healthc·Product code KWP·1998-10-26
K983265 — DEPUY ACE COMPOSITE LOCKING NUTDepuy Ace Medical Co.·Product code HTN·1998-10-26
K983639 — ZIPPIE GS, MODEL # EIZGSSunrise Medical, Inc.·Product code IOR·1998-10-25
K981791 — MGAbbott Laboratories·Product code JGJ·1998-10-23
K982128 — SHIKANI-FRENCH SPEAKING VALVEPilling Weck Surgical·Product code JOH·1998-10-23
K982604 — LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEMWalter Lorenz Surgical, Inc.·Product code MQN·1998-10-23
K982689 — WINSTATION RETINAL IMAGEROphthalmic Imaging Systems·Product code HKI·1998-10-23
K982725 — OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USEOlympus America, Inc.·Product code ITX·1998-10-23
K983077 — BIO PONTOSTARBego U.S.A.·Product code EJT·1998-10-23
K983078 — BEGOPALBego U.S.A.·Product code EJS·1998-10-23
K983079 — PLATINLLOYD 100Bego U.S.A.·Product code EJT·1998-10-23
K974395 — ATLANT'SGrad-Line Corp.·Product code IRP·1998-10-22
K980410 — SLE ELECTRODES AND ACCESSORIESSpecialized Laboratory Equipment, Ltd.·Product code GXY·1998-10-22
K980590 — VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADERVarian Medical Systems, Inc.·Product code JAQ·1998-10-22
K980828 — EXMOOR MYRINGOTOMY KITExmoor Plastics , Ltd.·Product code ETD·1998-10-22
K981209 — MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITSThe Binding Site, Ltd.·Product code MVM·1998-10-22
K981490 — WILLI GELLER CREATION PORCELAINJensen Industries, Inc.·Product code EIH·1998-10-22
K982133 — OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENTThe Olympus Optical Co.·Product code HRX·1998-10-22
K982255 — MODEL 2000 PULSE OXIMETERIvy Biomedical Systems, Inc.·Product code DQA·1998-10-22
K982533 — UNICAP GLIADIN IGA ASSAYPharmacia & Upjohn Co.·Product code MST·1998-10-22
K982576 — FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476Friatec AG·Product code DZE·1998-10-22
K982580 — BIRD MONITOR INTERFACEBird Products Corp.·Product code CBK·1998-10-22
K982593 — LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIEDentalez Group·Product code EFB·1998-10-22
K982692 — STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LCSterngold/Implamed·Product code EBF·1998-10-22
K982701 — UNICAP GLIADIN IGG ASSAYPharmacia & Upjohn Co.·Product code MST·1998-10-22
K982714 — BAYER IMMUNO 1 SYSTEM FERRITIN ASSAYBayer Corp.·Product code DBF·1998-10-22
K982761 — JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031Chamco, Inc.·Product code LNH·1998-10-22
K983018 — ZINC PHOSPHATE CEMENTMedental Intl.·Product code EMA·1998-10-22
K983057 — ORTHOPHOS 5/PLUS/CDSirona Dental Systems GmbH·Product code MUH·1998-10-22
K983107 — VFERamco Laboratories, Inc.·Product code GGP·1998-10-22
K974891 — ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013Acutek Adhesive Specialties, Inc.·Product code MGP·1998-10-21
K980485 — ISOLA SPINAL SYSTEMAcromed Corp.·Product code MNI·1998-10-21
K980601 — VARISOURCE WRIGHT VAGINAL CUFF APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERIOADERVarian Assoc., Inc.·Product code JAQ·1998-10-21
K981004 — SLE EMG ELECTRODES AND ACCESSORIESSpecialized Laboratory Equipment, Ltd.·Product code IKT·1998-10-21
K981208 — TFRRamco Laboratories, Inc.·Product code JNM·1998-10-21
K982013 — MGB LAPALUX TELESCOPEMgb Endoskopische Gerate GmbH·Product code GCJ·1998-10-21
K982566 — AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)Bar - Advanced Control Systems , Ltd.·Product code EWO·1998-10-21

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