FDA 510(k) clearances — page 1348

176,637 clearances on record, most recent first.

Clearances — page 1348

134,701–134,800 of 176,637

K884156 — HYPERBARIC INTRAVENOUS INFUSION EXTENSION SETSechrist Industries, Inc.·Product code FPK·1988-11-14
K884264 — HIGH RISK NEEDLE CONNECTOR ASSEMBLYVenture Molded Products, Inc.·Product code FPA·1988-11-14
K884418 — PREMIER DIE-TRAK ARTICULATORPremier Medical·Product code EJP·1988-11-14
K884553 — STAMEY NEEDLECook Ob/Gyn·Product code GEJ·1988-11-14
K884584 — TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADSEastmed Enterprises, Inc.·Product code BWB·1988-11-14
K881168 — CREATINE KINASE (CK) ISOENZYME MBData Medical Associates, Inc.·Product code JHT·1988-11-10
K881426 — PAN-PRA AID SELF-ADHE. COLLO. COATED BANDAGELaboratoire Pan-Pra·Product code NAD·1988-11-10
K882192 — HYGEIA URINE PREGNANCY TESTHygeia Sciences·Product code DHA·1988-11-10
K882570 — TURBOX THEOPHYLLINE ASSAYUnipath , Ltd.·Product code LER·1988-11-10
K882923 — KODAK SURECELL CHLAMYDIA TEST KITEastman Kodak Company·Product code LJC·1988-11-10
K883019 — SATURNE 42 AND 43General Electric Co.·Product code IYE·1988-11-10
K883621 — INSTRUMENTARIUM ULF MR IMAGING SYSTEMInstrumentarium Corp.·Product code LNH·1988-11-10
K883749 — PROBE(TM) MODELS 700 AND 1000Packard Instrument Co., Inc.·Product code JQW·1988-11-10
K883813 — CIBA CORNING BLOOD COLLECTION CAPILLARY TUBECiba Corning Diagnostics Corp.·Product code JKA·1988-11-10
K883816 — SHOULDER MICROSTRUCTURED HUMERAL PROSTHESISOsteonics Corp.·Product code KWS·1988-11-10
K883942 — HYCOR SENTRY DRUGS OF ABUSE URINE CONTROLIcl Scientific·Product code JJY·1988-11-10
K883972 — MAGNESIUM REAGENT (MAGON SULFONATE)Sigma Chemical Co.·Product code JGJ·1988-11-10
K884021 — EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95Em Diagnostic Systems, Inc.·Product code CFR·1988-11-10
K884100 — AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144Amersham Corp.·Product code JLS·1988-11-10
K884108 — MACROPORE MEDICAL/SURGICAL PAPER TAPELectec Corp.·Product code KGX·1988-11-10
K884181 — MANUAL SURGICAL INSTRUMENTS (SEVERAL MODELS)Sales & Marketing Assoc.·Product code GEN·1988-11-10
K884545 — DELFIA (TM) HIGE KITPharmacia, Inc.·Product code DGC·1988-11-10
K884548 — LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668Em Diagnostic Systems, Inc.·Product code CFJ·1988-11-10
K884549 — ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651Em Diagnostic Systems, Inc.·Product code CJE·1988-11-10
K881772 — SENSOCOR(TM) R-TEST 240 XLSensormedix, Inc.·Product code DXH·1988-11-09
K881954 — CONCEPT POWER SYSTEMConcept, Inc.·Product code HSZ·1988-11-09
K882254 — OEC-7102 ECG/NIBP MONITORNihon Kohden America, Inc.·Product code DPS·1988-11-09
K882635 — ELECTRONIC DIGITAL BLOOD PRESSURE MONITORNihon Seimitsu Sokki Co., Ltd.·Product code DXN·1988-11-09
K883178 — TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPECardiotronics, Inc.·Product code DRO·1988-11-09
K883215 — KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE SKirschner Medical Corp.·Product code JWH·1988-11-09
K883304 — TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRYCardiotronics, Inc.·Product code DRO·1988-11-09
K883843 — CARDIOBEEPER IISurvival Technology, Inc.·Product code DXH·1988-11-09
K883930 — SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALYSeamed Corp.·Product code DTE·1988-11-09
K883973 — MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500ANihon Kohden America, Inc.·Product code DXJ·1988-11-09
K884009 — MODEL 459 ELECTROCARDIOCORDER RECORDERDel Mar Avionics·Product code DSH·1988-11-09
K884465 — SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)Spirometrics, Inc.·Product code CAH·1988-11-09
K880723 — DIMENSION WHOLE BLOOD CHOLESTEROLTechnimed, Inc.·Product code CHH·1988-11-08
K881725 — ENVIROTENT (BED)Envirotents, Inc.·Product code FNJ·1988-11-08
K882715 — STERILE SURGICAL LATEX GLOVESPlastic Materials of Puerto Rico, Inc.·Product code KGO·1988-11-08
K882723 — ALCON FLUID INJECTORAlcon Laboratories·Product code DQF·1988-11-08
K883471 — VKG 1000, VIDEO KERATOMETERTechnitex, Inc.·Product code HLP·1988-11-08
K883587 — BIOSEARCH 3600 ENTRI FEEDING PUMPBiosearch Medical Products, Inc.·Product code FRN·1988-11-08
K884196 — SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)Disposable Sterile Surgical Instruments, Inc.·Product code HRQ·1988-11-08
K884255 — CONCEPT CCT-5200, THERMAL THERAPY SYSTEMConcept, Inc.·Product code ILO·1988-11-08
K884295 — SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVESaybrex Intl., Inc.·Product code LGM·1988-11-08
K884373 — KORBER ARTERIOTOMY SCISSORSMicrins, Ltd.·Product code LRW·1988-11-08
K884380 — BED SHEET, PILLOW CASESaybrex Intl., Inc.·Product code KME·1988-11-08
K884404 — HERNIASTATInnovative Surgical Devices Corp.·Product code GAG·1988-11-08
K884435 — RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTSClinical Connections, Inc.·Product code FMG·1988-11-08
K882138 — IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDERImex Medical Systems, Inc.·Product code DPW·1988-11-07
K882875 — STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORYLorad Medical Systems, Inc.·Product code IZH·1988-11-07
K883260 — DITTMAR POWER LIFTERDittmar and Penn Corp.·Product code FOX·1988-11-07
K883458 — OPTIMED ADVANTAGEOptimed, Inc.·Product code HPT·1988-11-07
K883573 — THERMOMETER, MERCURY/CLINICALUmax Corp.·Product code FLK·1988-11-07
K883664 — LUM VASCULAR PROCEDURE SYSTEM #B5200AGeneral Electric Co.·Product code IYB·1988-11-07
K883787 — REUSABLE ADULT INCONTINENT DIAPERIntera Corp.·Product code EYQ·1988-11-07
K884030 — ERGO II, SURGICAL LATEX GLOVESErgo Intl., Ent., Inc.·Product code KGO·1988-11-07
K884341 — CRITICAL CARE I.V. STAND STABILIZING BRACKETRbd Medical, Inc.·Product code FOX·1988-11-07
K884370 — CMS IV EXTENSION SETSChurchill Medical Systems, Inc.·Product code FPK·1988-11-07
K874096 — TITANIUM GREENFIELD VENA CAVA FILTER CARRIERMedi-Tech, Inc.·Product code DTK·1988-11-04
K881307 — OLV 1100; OLV 1200 PULSE OXIMETERSNihon Kohden America, Inc.·Product code DQA·1988-11-04
K882151 — PORT-O-HEAT, MODEL 0100Arthotronics, Inc.·Product code IRT·1988-11-04
K882939 — NIOBI-X RADIATION REDUCTION FILTERAmerican Canadian Products, Inc.·Product code ITY·1988-11-04
K882974 — FORCE GUARD IBoulder Impact Monitors, Inc.·Product code IRN·1988-11-04
K883481 — HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADEHewlett-Packard Co.·Product code IYO·1988-11-04
K883532 — ICOR AGENT MONITORIcor AB·Product code CBQ·1988-11-04
K883537 — QM300 CONTROL EKallestad Diag, A Div. of Erbamont, Inc.·Product code DHB·1988-11-04
K883541 — METALASER VASCULASEMetatech Corp.·Product code GEX·1988-11-04
K883579 — CORONARY GUIDE WIREDatascope Corp.·Product code DQX·1988-11-04
K883722 — CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAYCiba Corning Diagnostics Corp.·Product code CDD·1988-11-04
K883834 — MEDRAD OMNIPLANE 300 SYSTEMMedrad, Inc.·Product code KPR·1988-11-04
K883923 — CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIESGish Biomedical, Inc.·Product code DTN·1988-11-04
K884060 — MEDITEC QL-15 ND:YAG LASERStorz Ophthalmics, Inc.·Product code GEX·1988-11-04
K884217 — TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEINTechnicon Instruments Corp.·Product code LKL·1988-11-04
K884400 — ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)Immco Diagnostics, Inc.·Product code DHN·1988-11-04
K882129 — SYMBION CENTRIFUGAL BLOOD PUMP MODEL ISymbion, Inc.·Product code KFM·1988-11-03
K882271 — CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYNuccardiac Software, Inc.·Product code LLZ·1988-11-03
K882547 — VARITESTEureka AB·Product code JOM·1988-11-03
K883393 — CAPD DISPOSABLE Y SYSTEM - DY SETMedionics International , Ltd.·Product code KDJ·1988-11-03
K883564 — ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLESAdvanced Cardiovascular Systems, Inc.·Product code DQY·1988-11-03
K883603 — SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)3M Health Care, Sarns·Product code DWC·1988-11-03
K883855 — PREDICTOR II SIGNAL AVERAGING ECGCorazonix Corp.·Product code DXG·1988-11-03
K883981 — GUIDING CATHETER (TIP SOFTNESS CHANGE)Devices For Vascular Intervention, Inc.·Product code DWF·1988-11-03
K884015 — PREMIER DECANNULATION STOPPERPremier Dental·Product code BTO·1988-11-03
K884204 — COHERENT EXCELITE CO2 AIR FIBERCoherent Medical Lasers·Product code GEX·1988-11-03
K884342 — NOVAPATH SPECIMEN COLLECTION KITBio-Rad·Product code LIO·1988-11-03
K880639 — ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLEHuman Technologies, Inc.·Product code FLL·1988-11-02
K882352 — MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT.Clinical Information Systems, Inc.·Product code CCL·1988-11-02
K882377 — HEALTH-WATCH BED MONITOREngineering Developments, Co.·Product code BZQ·1988-11-02
K882951 — CO2 SURGICAL LASER SYSTEM MODEL #IR105Niic U.S.A., Inc.·Product code GEX·1988-11-02
K882952 — CO2 SURGICAL LASER SYSTEM MODEL #IR106Niic U.S.A., Inc.·Product code GEX·1988-11-02
K883384 — TS1000 SUCTION TIPM.D. Engineering, Inc.·Product code BSY·1988-11-02
K883590 — OXYTROLCryogenic Assoc.·Product code NFB·1988-11-02
K883591 — MARK-5 CONCENTRATORNidek Medical Products, Inc.·Product code CAW·1988-11-02
K884119 — TYPE 9230 TEMP 1 & 2 SYSTEM ATHENAS & W Medico Teknik·Product code FLL·1988-11-02
K884297 — SPQ(TM) TEST SYSTEM FOR PREALBUMINAtlantic Antibodies·Product code JZJ·1988-11-02
K884298 — SPQ(TM) TEST SYSTEM FOR MICROALBUMINAtlantic Antibodies·Product code JZJ·1988-11-02
K884427 — FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.Bivona Medical Technologies·Product code BTO·1988-11-02
K880868 — CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18Diagnostic Chemicals, Ltd. (Usa)·Product code KHS·1988-11-01
K881960 — MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74Med Service, Inc.·Product code FNL·1988-11-01

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