FDA 510(k) clearances — page 868

176,637 clearances on record, most recent first.

Clearances — page 868

86,701–86,800 of 176,637

K991520 — FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATIONFresenius Medical Care North America·Product code KDI·1999-07-30
K991523 — TLC PEDIATRIC FRAME, MODEL TLC-SYSRadionics, Inc.·Product code IYE·1999-07-30
K991535 — CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERASHitachi Medical Corp. of America·Product code KPS·1999-07-30
K991546 — AKTINA MEDICAL PHYSICS CORPORATION TILT BOARDAktina Medical Physics Corp.·Product code IYE·1999-07-30
K991581 — NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE COZimmer, Inc.·Product code JWH·1999-07-30
K991615 — POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVEMaxxim Medical·Product code LZA·1999-07-30
K991625 — KOMET XK-95 PERFORATOR MOTOR (MI-102)Komet Medical·Product code HBB·1999-07-30
K991708 — ZIRCONIA 22.22MM CERAMIC MODULAR HEADSBiomet, Inc.·Product code LZO·1999-07-30
K991725 — SIDESTREAM NEBULIZERInspired Medical Products , Ltd.·Product code CAF·1999-07-30
K991763 — LACTOSORB HAND SYSTEMBiomet, Inc.·Product code HRS·1999-07-30
K991870 — ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03A.P. Total Care, Inc.·Product code CGZ·1999-07-30
K991874 — EMS SURFACE MOUNT SCALER(Ems Sa) Electro Medical Systems·Product code ELC·1999-07-30
K991933 — DERMAPHYLYX FOAM ISLAND DRESSINGDermaphylyx, Inc.·Product code KMF·1999-07-30
K991937 — ULTRASOUND SCANNER, MODEL TYPE 2101B & K Medical A/S·Product code IYO·1999-07-30
K991968 — CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.Smith & Nephew, Inc.·Product code MDA·1999-07-30
K992018 — LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)La Glove (M) Sdn. Bhd.·Product code KGO·1999-07-30
K992037 — MAMEXDel Medical Imaging Corp.·Product code IZH·1999-07-30
K992061 — PULSTARLasermed, Inc.·Product code GEX·1999-07-30
K992146 — SCARAID SILICONE GEL SHEETINGBiodermis Corp.·Product code MDA·1999-07-30
K992186 — QUAD BIPOLAR LAPAROSCOPIC COAGULATING AND CUTTING INSTRUMENTConmedcorp·Product code GEI·1999-07-30
K992218 — DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601Kirwan Surgical Products, Inc.·Product code GEI·1999-07-30
K992219 — POWDERED LATEX STERILE SURGICAL GLOVESTg Medical Sdn. Bhd.·Product code KGO·1999-07-30
K992227 — CRIT-LINE MONITOR III (CLM III)In-Line Diagnostics Corp.·Product code MQS·1999-07-30
K992277 — STAPLETAC BONE ANCHOR SYSTEMInfluence, Inc.·Product code HWC·1999-07-30
K992288 — AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVETyco Intl. (Us), Inc.·Product code GCJ·1999-07-30
K992344 — OSTEONICS ACCP SYSTEM LINE EXTENSIONHowmedica Osteonics Corp.·Product code KWQ·1999-07-30
K992353 — BLUNT TIP TROCAR PORTOrigin Medsystems, Inc.·Product code GCJ·1999-07-30
K992408 — ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBESOratec Interventions, Inc.·Product code GEI·1999-07-30
K983120 — BICORTICAL SCREWOraltronics Marketing-Und Vertriebs GmbH·Product code DZE·1999-07-29
K984506 — SD-100 SKYEAR THERMOMETERSkylark Device Co., Ltd.·Product code FLL·1999-07-29
K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-XAsahi Medical Co., Ltd.·Product code FJI·1999-07-29
K991533 — MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATIONPeripheral Ave·Product code FGE·1999-07-29
K991591 — BIOTHANE PATIENT RESTRAINTBioplastics·Product code FMQ·1999-07-29
K991659 — UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIESMedart Corp.·Product code GEX·1999-07-29
K992100 — PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDEREDShanghai Palomar Mountain Industries, Inc.·Product code LYZ·1999-07-29
K992177 — NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGEPt. Berlian Glovindo·Product code LZA·1999-07-29
K992189 — GORE-TEX DUALMESH BIOMATERIALW. L. Gore & Associates, Inc.·Product code FTL·1999-07-29
K992206 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVESShanghai China Star Corp·Product code LYZ·1999-07-29
K992300 — QUICK-SERTER, MODEL 395Medtronic Minimed·Product code KZH·1999-07-29
K983270 — VOYAGER QUAD CANNULACardiothoracic Systems, Inc.·Product code DWF·1999-07-28
K984188 — AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)Chroma Vision Medical Systems, Inc.·Product code JOY·1999-07-28
K984501 — DADE BEHRING BFTIIDade Behring, Inc.·Product code JPA·1999-07-28
K990580 — CRYOCHECK LA SURE, MODEL SUR25-10Precision Biologic·Product code GIR·1999-07-28
K991497 — ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEMIcs Medical Corp.·Product code GWN·1999-07-28
K991503 — SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36United Pacific Co., Ltd.·Product code ILY·1999-07-28
K991702 — MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578Becton Dickinson Vacutainer Systems·Product code JKA·1999-07-28
K991945 — PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01Pharmacia & Upjohn Co.·Product code DGC·1999-07-28
K992167 — PERFORMANCE KNEE SYSTEMBiomet, Inc.·Product code JWH·1999-07-28
K992197 — MODIFICATION TO ZYMED HOLTER 2000Zymed Medical Instrumentation·Product code MLO·1999-07-28
K984627 — AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETERArterial Vascular Engineering, Inc.·Product code DQO·1999-07-27
K991517 — CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Galil Medical , Ltd.·Product code GEH·1999-07-27
K992251 — SWISS LITHOCLAST MULTIPURPOSE PROBEElectro Medical Systems SA·Product code FFK·1999-07-27
K984060 — LUER ACCESS INJECTION SITEBaxter Healthcare Corp·Product code FPA·1999-07-26
K984428 — SULLIVAN AUTOSET NASAL CPAP SYSTEMResmed, Ltd.·Product code BZD·1999-07-26
K990348 — WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816NCooperSurgical, Inc.·Product code MQF·1999-07-26
K990349 — WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NSTCooperSurgical, Inc.·Product code MQF·1999-07-26
K990350 — WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316CooperSurgical, Inc.·Product code MQF·1999-07-26
K991065 — CARESIDE PTCareside, Inc.·Product code GJS·1999-07-26
K991110 — REDI-TEST COCAINERedwood Biotech, Inc.·Product code DIO·1999-07-26
K991322 — ENHANCE-S PLUSConception Technology, Inc.·Product code MQL·1999-07-26
K991607 — VANTAGE 2.5Adac Laboratories·Product code KPS·1999-07-26
K991631 — FASTRAY LCHarry J. Bosworth Co.·Product code ELW·1999-07-26
K991668 — COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)Novartis Nutrition Corp.·Product code KNT·1999-07-26
K991902 — LC PIT & FISSURE SEALANTBosworth Co.·Product code EBC·1999-07-26
K991913 — PENTAMIX 2Espe Dental AG·Product code EFD·1999-07-26
K991951 — SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)Safeskin Corp.·Product code LYZ·1999-07-26
K992020 — BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)Brightsway Holdings Sdn Bhd·Product code KGO·1999-07-26
K992216 — BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANEIntegra Lifesciences Corp.·Product code LYC·1999-07-26
K992244 — GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBEGreiner Meditech, Inc.·Product code JKA·1999-07-26
K980070 — OSTEONICS HA-COATED DEVICESOsteonics Corp.·Product code MEH·1999-07-23
K990579 — CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)Precision Biologic·Product code GIR·1999-07-23
K990618 — VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)Ventana Medical Systems, Inc.·Product code MXZ·1999-07-23
K990732 — LAP-WAVE 3000 (P07)W.O.M. World of Medicine GmbH·Product code HET·1999-07-23
K990823 — PVS 1400 GUIDEWIREPrecision Vascular Systems, Inc.·Product code DQX·1999-07-23
K991446 — BIOSACA SYSTEM, MODEL 800Biosys AB (Publ)·Product code OLV·1999-07-23
K991586 — SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)Osteotech, Inc.·Product code KWP·1999-07-23
K992021 — BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)Brightsway Holdings Sdn Bhd·Product code KGO·1999-07-23
K992034 — DOCUMENT THYROID CAL*VERCasco-Nerl Diagnostics Corporation (Maine)·Product code JJY·1999-07-23
K992041 — RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11Immuno Concepts, Inc.·Product code LJM·1999-07-23
K992205 — PRE-POWDERED VINYL PATIENT EXAMINATION GLOVESShanghai China Star Corp·Product code LYZ·1999-07-23
K992231 — FOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.·Product code QEY·1999-07-23
K990476 — HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTIONHewlett-Packard GmbH·Product code MHX·1999-07-22
K991424 — INSULSCAN INSULATION TESTING SYSTEMMedicor Corp.·Product code HFG·1999-07-22
K991449 — SNORE-AID PLUSDental Imagineers, LLC·Product code LRK·1999-07-22
K991504 — REDI-TEST METHAMPHETAMINERedwood Biotech, Inc.·Product code LAF·1999-07-22
K991597 — COBAS INTEGRA AMIKACIN MABRoche Diagnostics Corp.·Product code LGJ·1999-07-22
K991598 — COBAS INTEGRA ACETAMINOPHENRoche Diagnostics Corp.·Product code LDP·1999-07-22
K991723 — TRANSFX MULTI PIN CLAMPImmedica, Inc.·Product code LXT·1999-07-22
K991741 — BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027Biocheck, Inc.·Product code JHI·1999-07-22
K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMBayer Corp.·Product code CIJ·1999-07-22
K992207 — QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEMSyntron Bioresearch, Inc.·Product code DIO·1999-07-22
K984392 — ANSELL CONDOMSAnsell, Inc.·Product code HIS·1999-07-21
K991557 — MEDRAD VISTRON CT INJECTOR SYSTEMMedrad, Inc.·Product code DXT·1999-07-21
K991588 — EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical Systems·Product code HSZ·1999-07-21
K991844 — PRO-GLASSCad Cam Ventures·Product code EIH·1999-07-21
K992142 — SCIMED ANGIOGRAPHIC CATHETERSScimed·Product code DQO·1999-07-21
K992328 — FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800Meditec Co., Ltd.·Product code DXN·1999-07-21
K984180 — THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEMZeus Scientific, Inc.·Product code LFX·1999-07-20
K990342 — SYNOCTA PROSTHETICSStraumann USA·Product code DZE·1999-07-20
K990656 — CHROMOPHARE D 530 LDR SURGICAL LIGHTBerchtold Holding GmbH·Product code FSY·1999-07-20

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