FDA 510(k) clearances — page 1183

176,637 clearances on record, most recent first.

Clearances — page 1183

118,201–118,300 of 176,637

K921118 — ACS APCT REAGENTAnalytical Control Systems, Inc.·Product code GFO·1992-07-28
K921180 — COBAS CORE IMMUNOCHEMISTRY SYSTEMRoche Diagnostic Systems, Inc.·Product code JJQ·1992-07-28
K921302 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEMVitek Systems, Inc.·Product code JHI·1992-07-28
K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYPro-Lab, Inc.·Product code LHL·1992-07-28
K921787 — SYNELISA TPO ANTIBODIESElias U.S.A., Inc.·Product code JNL·1992-07-28
K922000 — MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COILMri Devices Corp.·Product code LNH·1992-07-28
K922001 — SPECTACLE FRAMESOtego Optical, Inc.·Product code HQZ·1992-07-28
K922084 — MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOMGen Trak, Inc.·Product code GKZ·1992-07-28
K922085 — MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOMGen Trak, Inc.·Product code GKZ·1992-07-28
K922151 — WAKO AUTOKIT RFWako Chemicals USA, Inc.·Product code DHR·1992-07-28
K922168 — ANTIMICROBIAL SUSCEPTIBILITY TEST PANELAlamar Biosciences Laboratory, Inc.·Product code JWY·1992-07-28
K922563 — LIFE-TEL L.B.E. (LIFE-PAK 5 BATTERY ELIMINATOR)Raco Products Co.·Product code LDD·1992-07-28
K922791 — LORACARBEF 30MCG DISKDifco Laboratories, Inc.·Product code JTN·1992-07-28
K922793 — CEFZILDifco Laboratories, Inc.·Product code JTN·1992-07-28
K922794 — ENOXACINDifco Laboratories, Inc.·Product code JTN·1992-07-28
K922884 — OLYMPUS ALANINE AMINOTRANSFERASE REAGENTOlympus Corp.·Product code CKA·1992-07-28
K922885 — OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENTOlympus Corp.·Product code CIT·1992-07-28
K915059 — PEAK FLOW MONITORSpirometrics, Inc.·Product code BZH·1992-07-27
K915268 — CATHETER TWO STAGE VENOUS RETURNDlp, Inc.·Product code DWF·1992-07-27
K920222 — HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUSAkers Research Corp.·Product code LJO·1992-07-27
K920604 — BIVONA TRACHEAL T-TUBE STENTBivona Medical Technologies·Product code BTO·1992-07-27
K920614 — HEMO-BANDInnovations IN Access, Inc.·Product code KOC·1992-07-27
K920738 — ACE 100 DEGREES TUBULAR PLATEAce Orthopedic Manufacturing Co.·Product code HRS·1992-07-27
K920836 — SUNGLASSESA Toz Importing Co.·Product code HQY·1992-07-27
K921011 — PHARMACIA CMV IGM ELISAPharmacia Diagnostics, Inc.·Product code LFZ·1992-07-27
K921326 — DADE RECOMBOPLASTIN SBaxter Diagnostics, Inc.·Product code GJS·1992-07-27
K921390 — XENON LIGHT SOURCE AND ACCESSORIESCoopervision Surgical·Product code GCT·1992-07-27
K921937 — NOVA NUCLEUS CLINICAL CHEMICAL SYST, MODIFICATIONNova Biomedical Corp.·Product code JGS·1992-07-27
K922098 — CAG-02AToshiba America Medical Systems, In.C·Product code KXJ·1992-07-27
K922165 — ATC725, ATC525, AND AP300Gendex Corp.·Product code IZO·1992-07-27
K922493 — AMERICAN MEDICAL MFG. LUMBAR CPMAmerican Medical Corp.·Product code BXB·1992-07-27
K922538 — VENTREX ALLERGEN DISCHycor Biomedical, Inc.·Product code DHB·1992-07-27
K922704 — COULTER MAXM W/ AUTOLOADERCoulter Electronics, Inc.·Product code GKZ·1992-07-27
K922996 — MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICSChiron Vision Corp.·Product code KYG·1992-07-27
K923177 — OPTICAL FRAMESA Toz Importing Co.·Product code HQZ·1992-07-27
K911221 — ATRAUMATIC SPECIAL SPROTTE NEEDLEPajunk GmbH·Product code BSP·1992-07-24
K914772 — MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001Medix Corp.·Product code CAF·1992-07-24
K914918 — LASERSCOPE'S MICROSPOT DERMASTATLaserscope·Product code GEX·1992-07-24
K920135 — MEDROYAL ANGIOGRAPHIC CONTROL SYRINGEMedroyal, Inc.·Product code DXT·1992-07-24
K921913 — HYPO-GARDEpi Medical Products, Inc.·Product code MMK·1992-07-24
K922302 — JAGWIRE(TM) RECANALIZATION GUIDEWIREBoston Scientific Corp·Product code DQX·1992-07-24
K922535 — THE TERMINATORTop End Wheelchair Sports, Inc.·Product code IOR·1992-07-24
K913302 — DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIEDCarwild Corp.·Product code GDY·1992-07-23
K915219 — URETHRAL ELECTRODE SHEATHApplied Urology, Inc.·Product code FAS·1992-07-23
K915608 — BICUTBerchtold Holding GmbH·Product code GEI·1992-07-23
K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGEBiotrack, Inc.·Product code DIP·1992-07-23
K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGEBiotrack, Inc.·Product code KLT·1992-07-23
K920202 — LATEX EXAM/SURGICAL GLOVESRedsun Latex , Ltd.·Product code LYY·1992-07-23
K920217 — MAX-E-VACLeisegang Medical, Inc.·Product code GEI·1992-07-23
K920575 — MERKUR 4000F.M. Wiest USA, Inc.·Product code FAP·1992-07-23
K920649 — COMPASEPWilde-USA, Inc.·Product code FMC·1992-07-23
K920653 — IL TEST BILIRUBIN TOTAL/DIRECTInstrumentation Laboratory CO·Product code CIG·1992-07-23
K920796 — DEROYAL TRANSPARENT FILM DRESSIGNDeroyal Industries, Inc.·Product code MGP·1992-07-23
K921195 — NASAL SEPTAL SPLINTSmith & Nephew Richards, Inc.·Product code LYA·1992-07-23
K921202 — TURBINATE NASAL SPLINTSmith & Nephew Richards, Inc.·Product code LYA·1992-07-23
K921435 — ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTUREGen-Probe, Inc.·Product code LQF·1992-07-23
K921810 — CURASOL(TM) WOUND DRESSINGHealthsouth Medical Center·Product code MGQ·1992-07-23
K921997 — CUFF-MLorin Medical, Inc.·Product code DXQ·1992-07-23
K922024 — REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175Helena Laboratories·Product code CEF·1992-07-23
K922193 — OSTEO KIRSCHNER WIREOsteo AG·Product code HTY·1992-07-23
K922194 — OSTEO STEINMANN PINOsteo AG·Product code HTY·1992-07-23
K922195 — OSTEO FEMORAL NAILOsteo AG·Product code HSB·1992-07-23
K922196 — OSTEO TIBIA NAILOsteo AG·Product code HSB·1992-07-23
K922410 — SCIMED AVENUE CORONARY GUIDEWIRE INSERTION TOOLScimed Life Systems, Inc.·Product code DQX·1992-07-23
K922721 — VLC DYCAL IIDentsply Intl.·Product code EJK·1992-07-23
K923350 — CLOSED CHAIN ATTACHMENT, MODEL #820-520Biodan Medical Systems, Ltd.·Product code IKK·1992-07-23
K922490 — ABBOTT STREP A CONTROLSAbbott Laboratories·Product code GTY·1992-07-22
K912405 — LATEX PROPHYLACTIC (CONDOM)Hevealactics Intl. Sdn Bhd·Product code HIS·1992-07-21
K914136 — COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASECoherent Medical Group·Product code GEX·1992-07-21
K915738 — EXCEL CT TWINElscint, Inc.·Product code JAK·1992-07-21
K920071 — MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15Medical Devices, Inc.·Product code GEI·1992-07-21
K920198 — GLYCOMAT HAEMOGLOBIN ANALYSERDrew Scientific , Ltd.·Product code LCP·1992-07-21
K920248 — MODEL SLASE 210 HOLMIUM LASER SYSTEMSunrise Technologies, Inc.·Product code GCX·1992-07-21
K920430 — MODULAR ACETABULAR CUP SYSTEMSmith & Nephew Richards, Inc.·Product code JDI·1992-07-21
K920844 — PIM 1.0 LASER DOPPLER PERFUSION IMAGERLisca Development AB·Product code DPW·1992-07-21
K921201 — VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST.Med Institute, Inc.·Product code LJT·1992-07-21
K921249 — WAKO AUTOKIT LIPASE-COLORWako Chemicals USA, Inc.·Product code CHI·1992-07-21
K921431 — POTTY PAGERIdeas For Living·Product code KPN·1992-07-21
K921495 — DIA STRIPS SYSTEM, MODIFIEDSymcon Intl., Inc.·Product code JIO·1992-07-21
K921540 — COOLING/HEATING THERAPY DEVICETempacure Home Care·Product code ILO·1992-07-21
K921718 — OLYMPUS ISE MODULEOlympus Corp.·Product code JGS·1992-07-21
K921844 — KODAK EKTACHEM DT SLIDES (NBIL)Eastman Kodak Company·Product code CIG·1992-07-21
K921856 — TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH.Schneider Intl., Ltd.·Product code LIT·1992-07-21
K921951 — MPG 65-80-100 X-RAY GENERATOR AND CONTROLGeneral Electric Co.·Product code IZO·1992-07-21
K922031 — HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROLMedtronic Hemotec, Inc.·Product code JOX·1992-07-21
K922033 — SALINE SOLUTION- STERILETrinity Laboratories, Inc.·Product code CCQ·1992-07-21
K922121 — SUNGLASSESPavilion Investment , Ltd.·Product code HQY·1992-07-21
K922125 — STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAYBaxter Diagnostics, Inc.·Product code DDR·1992-07-21
K922138 — VISTA ULTRASENSITIVE HTSH ASSAYSyva Co.·Product code JLW·1992-07-21
K922139 — VISTA IMMUNOASSAY SYSTEM -- MODIFICATIONSyva Co.·Product code JJE·1992-07-21
K922150 — EXAMINATION LAMPAir-Shields, Inc.·Product code KZF·1992-07-21
K922158 — PROTECTOR SYRINGE SAFETY CAP SYSTEMInjectimed, Inc.·Product code FMI·1992-07-21
K922659 — GENERAL SURGERY CLAMP AND NEEDLE HOLDERMiltex Instrument Co.·Product code GDJ·1992-07-21
K922784 — SYNERMED UIBC REAGENT KITSynermed, Inc.·Product code JMO·1992-07-21
K923021 — AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Corp.·Product code KHO·1992-07-21
K923095 — KAYE MODEL KIAO PELVIC/THIGH STABILIZERKaye Products, Inc.·Product code INN·1992-07-21
K923325 — MODEL 600 MEDICAL TREATMENT TABLETri W-G, Inc.·Product code INQ·1992-07-21
K911636 — GENESIS(TM) INFUSION SYSTEMNorman'S·Product code MEB·1992-07-17
K913392 — OXYGEN SENSING DEVICE, MODIFICATIONDevilbiss Health Care, Inc.·Product code CCL·1992-07-17
K915321 — BTM-200 (PROPOSED) POWERED MUSCLE STIMULATORBt Medical Co., Inc.·Product code IPF·1992-07-17

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