FDA 510(k) clearances — page 1382

176,637 clearances on record, most recent first.

Clearances — page 1382

138,101–138,200 of 176,637

K875062 — EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628Em Diagnostic Systems, Inc.·Product code GJS·1988-02-11
K875081 — IMMPULSE T4 ASSAY REAGENTSSclavo, Inc.·Product code CDX·1988-02-11
K875148 — MEDICRAT, HYPODERMIC SYRINGES & NEEDLESKnowltech Ind., Inc.·Product code FMF·1988-02-11
K875196 — DISPOSABLE CORONARY CONTROL SYRINGE 12CCMerit Medical Systems, Inc.·Product code DXT·1988-02-11
K880010 — REVISED LABELING FOR ADX OPIATESAbbott Laboratories·Product code DJG·1988-02-11
K880011 — REVISED LABELING FOR ADX PHENCYCLIDINEAbbott Laboratories·Product code LCL·1988-02-11
K880014 — REVISIED LABELING FOR ADX BENZODIAZEPINESAbbott Laboratories·Product code JXM·1988-02-11
K880032 — MEDEX MACHINEMedex, Inc.·Product code ISD·1988-02-11
K880069 — LEECO PREGNASTICK (EIA) CATALOG #003Leeco Diagnostics, Inc.·Product code LCX·1988-02-11
K880078 — UREA NITROGEN (BUN)Tech-Neal Scientific, Inc.·Product code CDQ·1988-02-11
K880089 — FINNIGAN MAT TSQ-70Finnigan Corp.·Product code DOP·1988-02-11
K880181 — REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAYReganes, Inc.·Product code CAZ·1988-02-11
K880278 — MALLEABLE PTFE COATED BRAIN SPATULAEDowns Surgical , Ltd.·Product code HAO·1988-02-11
K874873 — COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1Diagnostic Products Corp.·Product code DHN·1988-02-10
K875246 — LIPOGEN ANA TEST KITLipogen, Inc.·Product code LJM·1988-02-10
K875281 — QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code DEM·1988-02-10
K875283 — QM2/QM300 CONTROL B PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code DEM·1988-02-10
K875356 — IMMUNOGLOBULIN G & G SUBCLASSESBirmingham·Product code DEW·1988-02-10
K880148 — INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TESTAmpcor, Inc.·Product code KTN·1988-02-10
K880164 — RF CARD TEST & RF LIQUID TESTAmpcor, Inc.·Product code DHR·1988-02-10
K880198 — GEMINI SURGICAL LIGHTAmerican Sterilizer Co.·Product code FSS·1988-02-10
K880244 — SURGICAL BLADESAilee C/O Havel'S, Inc.·Product code GES·1988-02-10
K880252 — THERMAL-PAK MODEL SW 1000Micro Tek Engineering·Product code LHC·1988-02-10
K874844 — CARE TELSTAT MODELS: MP 5010 AND MP 5020Care Systems, Inc.·Product code DRT·1988-02-09
K874940 — CALIBRATION REFERENCE PLASMABaxter Healthcare Corp·Product code GGP·1988-02-09
K875197 — OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASEPro-Optics, Inc.·Product code LRX·1988-02-09
K875310 — RETICULOCYTE STAINSigma Diagnostics, Inc.·Product code KFC·1988-02-09
K880077 — FIBRINOSTICONOrganon Teknika Corp.·Product code GHH·1988-02-09
K872817 — 5 MHZ DOPPLER OUTRIGGERPhilips Ultrasound, Inc.·Product code IYN·1988-02-08
K873031 — STARKEY MODEL P1 MODULEStarkey Laboratories, Inc.·Product code LRB·1988-02-08
K874388 — KODAK SURECELL(TM) HCG-URINE KITEastman Kodak Company·Product code JHI·1988-02-08
K874690 — GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETERMentor Corp.·Product code FFX·1988-02-08
K874709 — DIAMOND MEDICAL, INC. MODEL DM 800Diamond Medical, Inc.·Product code FFT·1988-02-08
K874710 — DIAMOND MEDICAL, INC. MODEL DM 600Diamond Medical, Inc.·Product code FFT·1988-02-08
K874774 — TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERSVinyl Technology, Inc.·Product code LHX·1988-02-08
K874821 — LUNAR CASTING ALLOY FOR PORCELAIN-FUSED-TO-METALDeringer-Ney, Inc.·Product code EJS·1988-02-08
K874857 — KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0Eastman Kodak Company·Product code JJE·1988-02-08
K874944 — MODIFIED PRISMA SHIELD PIT & FISSURE SEALANTDentsply Intl.·Product code EBC·1988-02-08
K875084 — CABOT MEDICAL ENDOMETRIAL SUCTION CURETTECabot Medical Corp.·Product code HHK·1988-02-08
K875263 — ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R)Technicon Instruments Corp.·Product code JGS·1988-02-08
K870884 — RADIALLY-SUPPORTED VASCULAR PROSTHESESIntervascular, Inc.·Product code DSY·1988-02-05
K873173 — MEDRAD MRI INJECTION SYSTEMMedrad, Inc.·Product code DXT·1988-02-05
K873693 — LEVTECH COMPOSITE TRACTION TONGSLevtech, Inc.·Product code HAX·1988-02-05
K873955 — NAMIC ANGIOGRAPHIC SYRINGENorth American Instrument Corp.·Product code DXT·1988-02-05
K873990 — IRAS EDS INTERFEROMETRIC STIMULATORRandwal Instrument Co., Inc.·Product code HLX·1988-02-05
K874171 — MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEMHewlett-Packard Co.·Product code DQK·1988-02-05
K874176 — BIOTIS (TM) HAEMOPHILUS DUCREYIOtisville Biopharm, Inc.·Product code JSJ·1988-02-05
K874338 — TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610A&D Engineering, Inc.·Product code DSK·1988-02-05
K874493 — BELLA - VAC IRRIGATORBel-Can Industries·Product code KQT·1988-02-05
K874681 — SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYESKlockner Contract Packaging, Inc.·Product code HQG·1988-02-05
K874801 — ORTHODERM THERAPY BEDHealth Products, Inc.·Product code FNM·1988-02-05
K874811 — MODEL 5202 MICROMANIPULATORCoherent Medical Group·Product code GEX·1988-02-05
K874815 — TARGET THERAPEUTICS STERILE PRODUCTSTarget Therapeutics·Product code DQO·1988-02-05
K874852 — POLYSTAN WIRE REINFORCED TWO STAGE CATHETERSPolystan C/O Vitalcor, Inc.·Product code DWF·1988-02-05
K874853 — POLYSTAN TWO STAGE CATHETERSPolystan C/O Vitalcor, Inc.·Product code DWF·1988-02-05
K874885 — LAWRENCE L3000 CARDIAC OUTPUT MONITORLawrence Medical Systems, Inc.·Product code DPW·1988-02-05
K874960 — CARDIOVASCULAR SURGICAL INSTRUMENTSSolway, Inc.·Product code DWS·1988-02-05
K875026 — ANOMALOSCOPE PLATE TEST - 5 [APT-5]Lkc Technologies, Inc.·Product code HIT·1988-02-05
K875093 — NEW MODEL MB-550 BLOOD PRESSURE MONITORSharp Electronics Corp.·Product code DXN·1988-02-05
K875369 — MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUITDiamond Medical, Inc.·Product code FFT·1988-02-05
K880274 — ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPSAdvanced Surgical Products, Inc.·Product code HNR·1988-02-05
K871828 — TED MODEL 760Teledyne, Inc.·Product code CCK·1988-02-04
K873041 — A-V RECORDERLife Sciences Manufacturing, Inc.·Product code DPT·1988-02-04
K873540 — AEROBICA - LUNG EXERCISERMBA Healthcare Products, Inc.·Product code BWF·1988-02-04
K874298 — MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAMEEngineered Orthopedic Technologies, Inc.·Product code HBL·1988-02-04
K874429 — HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12Hf Scientific, Inc.·Product code GIQ·1988-02-04
K874592 — THROMBOPLASTIN.CBaxter Healthcare Corp·Product code GJS·1988-02-04
K874648 — COHERENT XA-30/SP CO2 SURGICAL LASERCoherent Medical Group·Product code GEX·1988-02-04
K874747 — 10CC SYRINGE CONTROL RING SETProcedure Products, Inc.·Product code FMF·1988-02-04
K874807 — EXTRAVAKITCancer Technologies, Inc.·Product code FMF·1988-02-04
K874914 — ORTHOMET ORTHOPEDIC STAPLESOrthomet, Inc.·Product code JDR·1988-02-04
K875180 — V-TREND RPRL CARD TESTTexas Immunology, Inc.·Product code GMP·1988-02-04
K880157 — MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TESTSyva Co.·Product code GON·1988-02-04
K880205 — EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIESBaxter Healthcare Corp·Product code HRX·1988-02-04
K880280 — BREEZY WHEELCHAIRMotion Designs, Inc.·Product code IOR·1988-02-04
K871848 — NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMPPanamedix, Inc.·Product code KNT·1988-02-03
K874775 — ELECTRODE TIP CLEANERC.R. Bard, Inc.·Product code GEI·1988-02-03
K874915 — ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESISOrthomet, Inc.·Product code KWL·1988-02-03
K875249 — SUTTER PHALANGEAL CAPSutter Biomedical, Inc.·Product code KWD·1988-02-03
K875252 — ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METHE.I. Dupont DE Nemours & Co., Inc.·Product code LDJ·1988-02-03
K875304 — BIOTROL CALIBRANT LEVEL 2Biotrol, USA, Inc.·Product code JIX·1988-02-03
K880222 — ZENITH TRAVELER CHIROPRACTIC TABLEWilliams Manufacturing Co.·Product code INW·1988-02-03
K880271 — RESUBMITTED EXCALIBURQuinton, Inc.·Product code ISD·1988-02-03
K870058 — PIE MEDICAL SCANNER 1000Pie Data Medical BV·Product code KNG·1988-02-02
K870653 — ULTRASOUND LINEAR/SECTOR SCANNER 1100Pie Data Medical BV·Product code KNG·1988-02-02
K870708 — GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEMKyoto Daiichi Kagaku Co., Ltd.·Product code LFR·1988-02-02
K870841 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYNDirected Energy, Inc.·Product code HHR·1988-02-02
K872709 — MODEL 20-C, RL-20A/U, OB-10A/UDirected Energy, Inc.·Product code HHR·1988-02-02
K872843 — OVEIA (TM) DUAL ANALYTEBoots-Celltech Diagnostics, Inc.·Product code JLP·1988-02-02
K873199 — OHMEDA 4700 OXICAP MONITOROhmeda Medical·Product code DQA·1988-02-02
K873892 — SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USELaserguide·Product code LNK·1988-02-02
K873924 — PTI HEART-CHILL POUCH/PAD SLING (STERILE)Buckman Co., Inc.·Product code DWC·1988-02-02
K873962 — MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEADMedtronic Vascular·Product code DTB·1988-02-02
K873986 — BETA-HCG ASSAYSchiff & Co.·Product code DHA·1988-02-02
K874087 — MODIFIED CALCITONIN RIA KIT DSL #1200Diagnostic Systems Laboratories, Inc.·Product code JKR·1988-02-02
K874205 — ENDOCARDIAL SCREW-IN LEAD, MODEL 1018TPacesetter Systems·Product code DTB·1988-02-02
K874302 — QUANTIMETRIX TOTAL CREATINE KINASE CONTROLQuantimetrix Medical Industries·Product code JJT·1988-02-02
K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORMallinckrodt Critical Care·Product code KRI·1988-02-02
K874659 — STERILIZATION OF DEVICES BY RADIATIONInhalation Plastics·Product code BTT·1988-02-02
K874692 — PULSEMATE BX-5Colin Medical Instruments Corp.·Product code DQA·1988-02-02

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