FDA 510(k) clearances — page 1248

176,637 clearances on record, most recent first.

Clearances — page 1248

124,701–124,800 of 176,637

K904758 — CARDIOFAX ECG-8830ANihon Kohden America, Inc.·Product code DPS·1990-12-13
K904856 — ABUSCREEN ONTRAK FOR THCRoche Diagnostic Systems, Inc.·Product code LDJ·1990-12-13
K904866 — COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, Inc.·Product code JHT·1990-12-13
K904960 — QUALTEX SURGICAL DRAPEDeroyal Industries, Inc.·Product code KKX·1990-12-13
K905176 — POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREENQuidel Corp.·Product code DHB·1990-12-13
K905193 — DIASTAT ANTI-LA (SS-B)Shield Diagnostics, Ltd.·Product code LKO·1990-12-13
K905194 — DIASTAT ANTI-RO (SS-A)Shield Diagnostics, Ltd.·Product code LKO·1990-12-13
K905202 — TURBIQUANT MYOGLOBINBehring Diagnostics, Inc.·Product code DDR·1990-12-13
K905380 — 1-CUT ACL GRAFT KNIFEDepuy, Inc.·Product code GDX·1990-12-13
K905386 — DISTAT ANTI-DSDNA KITShield Diagnostics, Ltd.·Product code KTL·1990-12-13
K903662 — PEEWEE REPLACEMENT GASTROSTOMY TUBEBiosearch Medical Products, Inc.·Product code KNT·1990-12-12
K904227 — MULTILASE 45Laser Photonics, Inc.·Product code GEX·1990-12-12
K904229 — MULTILASE 60Laser Photonics, Inc.·Product code GEX·1990-12-12
K904488 — KALTOSTAT WOUND DRESSINGCalgon Vestal Div.·Product code QSY·1990-12-12
K904566 — NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZERCobe Laboratories, Inc.·Product code FJI·1990-12-12
K904667 — NA NEEDLESOlympus Corp.·Product code GDM·1990-12-12
K904969 — HOOD, OPERATING, SURGICALChicago Assoc. For Retarded Citizens·Product code FXY·1990-12-12
K902295 — OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESHCeramed Corp.·Product code LYC·1990-12-11
K903151 — INTERVERTEBRAL DISC RONGEURVon Zeppelin GmbH·Product code HAE·1990-12-11
K904004 — AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116Amresco, Inc.·Product code CGS·1990-12-11
K904209 — SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PEBd Becton Dickinson Vacutainer Systems Preanalytic·Product code GKZ·1990-12-11
K904436 — QUICKANCHOR (TM)Mitek Surgical Products, Inc.·Product code GAS·1990-12-11
K904905 — DOA LIQUID MULTI-ANALYTE DRUGS OF ABUSE CONTROLSMedical Analysis Systems, Inc.·Product code DIF·1990-12-11
K905005 — DISPOSABLE SURGICAL TOWEL (NON-STERILE)Marand Products, Inc.·Product code KKX·1990-12-11
K905152 — REMOTE CONTROLLED X-RAY DIAG. RSZ-200Shimadzu Medical Systems·Product code IXR·1990-12-11
K905153 — REMOTE CONTROLLED X-RAY DIAGNOSTIC RS-110Shimadzu Medical Systems·Product code IXR·1990-12-11
K905226 — TRIGLYCERIDE (GPO) REAGENT, UNIVERSALEnzyme Technology, Inc.·Product code JGY·1990-12-11
K905284 — HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173Amresco, Inc.·Product code LBR·1990-12-11
K905334 — THOMPSON TYPE HIP PROSTHESISO'Tec Corp.·Product code KWL·1990-12-11
K905336 — STEINMAN PIN, THREADEDO'Tec Corp.·Product code JDW·1990-12-11
K905337 — STEINMAN PINO'Tec Corp.·Product code HTY·1990-12-11
K905338 — SIDE PLATEO'Tec Corp.·Product code KTT·1990-12-11
K905341 — RUSH PINO'Tec Corp.·Product code HTY·1990-12-11
K905342 — LAG SCREWO'Tec Corp.·Product code KTT·1990-12-11
K905344 — KNOWLES PINO'Tec Corp.·Product code JDW·1990-12-11
K905345 — K-WIREO'Tec Corp.·Product code HTY·1990-12-11
K905346 — JEWETT HIP NAILO'Tec Corp.·Product code KTT·1990-12-11
K905348 — HANSEN-STREET TYPE INTRAMEDULLARY NAILO'Tec Corp.·Product code KTW·1990-12-11
K905349 — AUSTIN MOORE TYPE HIP PROTHESISO'Tec Corp.·Product code KWL·1990-12-11
K905352 — BLADE PLATEO'Tec Corp.·Product code KTT·1990-12-11
K905362 — BARBED SQUARE STAPLEO'Tec Corp.·Product code JDR·1990-12-11
K905363 — FIXATION STAPLEO'Tec Corp.·Product code JDR·1990-12-11
K905364 — ROUND STAPLEO'Tec Corp.·Product code JDR·1990-12-11
K901005 — TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)Danek Medical, Inc.·Product code KWP·1990-12-10
K902775 — KNIGHT SACRAL SCREWDanek Medical, Inc.·Product code KWP·1990-12-10
K903489 — THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000Pegasus Research Corp.·Product code BWF·1990-12-10
K904173 — INSULATED ELECTRODES AND LAPAROSCOPIC PROBICSBaxter Healthcare Corp·Product code HET·1990-12-10
K904476 — VESSEL DILATORDatascope Corp.·Product code DRE·1990-12-10
K905228 — MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZBaxter Healthcare Corp·Product code FJI·1990-12-10
K900404 — VARICOSCREEN(TM)Promedex, Inc.·Product code KYA·1990-12-07
K902225 — CHILDRENS SUNGLASSESJasco Products Co., Inc.·Product code HQY·1990-12-07
K902488 — MODIFIED CASS SYSTEMMedical Instrumentation & Diagnostics Corp.(Midco)·Product code KXK·1990-12-07
K902740 — LDL-DIRECT CONTROLSIsolab, Inc.·Product code JJY·1990-12-07
K902809 — BRACKET, METAL, ORTHODOTNICMasel Industries, Inc.·Product code EJF·1990-12-07
K903790 — ENDOSCOPIC LIGHT SOURCE 250 ENDOOrlux Engineering and Instrumentation·Product code FCW·1990-12-07
K904203 — SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEMSurgilase, Inc.·Product code GEX·1990-12-07
K904279 — PAROJECT ANESTHETIC SYRINGERonvig Instruments, Ltd.·Product code EGM·1990-12-07
K904330 — TURBO-RAST SPECIFIC IGE ASSAYVentrex Laboratories, Inc.·Product code DHB·1990-12-07
K904361 — KLEARTEX LATEX SURGEONS GLOVESKleartex Sdn Bhd·Product code KGO·1990-12-07
K904401 — BATTERY-POWERED TOOTHBRUSHThe B & F System, Inc.·Product code JEQ·1990-12-07
K904402 — NIDEK INC. MODEL AC-2000 DERMNidek, Inc.·Product code GEX·1990-12-07
K904576 — HEARING AID, UNITRON MODEL UM60-UHUnitron Industries, Inc.·Product code ESD·1990-12-07
K904724 — CONQUEST DIRECT FILLING COMPOSITE (DFC)Jeneric/Pentron, Inc.·Product code KLE·1990-12-07
K904730 — QUALITONE ULTRA CANAL GENESISQualitone·Product code ESD·1990-12-07
K904774 — INGLAT-O-BALLMilex Products, Inc.·Product code HHW·1990-12-07
K904872 — HDL CHOLESTEROL CONTROLAnalytical Control Systems, Inc.·Product code JJY·1990-12-07
K905190 — DIASTAT ENA PROFILEShield Diagnostics, Ltd.·Product code LJM·1990-12-07
K905191 — DIASTAT ANTI-SMShield Diagnostics, Ltd.·Product code LKP·1990-12-07
K905192 — DIASTAT ANTI-SM/RNPShield Diagnostics, Ltd.·Product code LKP·1990-12-07
K903740 — TRACH-EZESorex Medical·Product code BSY·1990-12-06
K903931 — GORE-TEX(R) STRETCH VASCULAR GRAFTW. L. Gore & Associates, Inc.·Product code DSY·1990-12-06
K904040 — SOFTSHELL VENOUS RESERVOIRC.R. Bard, Inc.·Product code DTN·1990-12-06
K904075 — CLINICAL CHEMISTRY CONTROLPhoenix Diagnostics, Inc.·Product code JJY·1990-12-06
K904143 — V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLESBaxter Healthcare Corp·Product code HET·1990-12-06
K904171 — SCIMED CARDIOTHERM CARDIOPLEGIA DELIVERY SYSTEMScimed·Product code DTR·1990-12-06
K904477 — GUIDEWIREDatascope Corp.·Product code DQX·1990-12-06
K904782 — ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TESTCarter Products·Product code LCX·1990-12-06
K904819 — SHUR-LOCK ICE WRAP SYSTEMConco Medical Co.·Product code IMD·1990-12-06
K904829 — ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROLAnalytical Control Systems, Inc.·Product code JJY·1990-12-06
K904968 — QCLYTE PROTEIN BASED ISE CONTROLBaxter Healthcare Corp·Product code JJY·1990-12-06
K905098 — ELEGANCE GH ELISABioclone Australia Pty , Ltd.·Product code CFL·1990-12-06
K905293 — SYSTEM 90 AND 95Folio Products, Inc.·Product code ITI·1990-12-06
K900464 — MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBEMedical Innovations Corp.·Product code KNT·1990-12-05
K900932 — 37-702 AND 37-703 PC RAINBOWVictoreen, Inc.·Product code IYI·1990-12-05
K902724 — ADVANCE DISPOSABLE STOPCOCKAdvance Medical Designs, Inc.·Product code FMG·1990-12-05
K903346 — DISPOSABLE EMISSIONS BARRIER LASER DRAPEWave-Form Systems, Inc.·Product code KKX·1990-12-05
K903417 — VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATHVas-Cath, Inc.·Product code LIT·1990-12-05
K903461 — TSRH OFFSET AND SIDE-LOADING HOOKSDanek Medical, Inc.·Product code KWP·1990-12-05
K903672 — DENE BRIDGEDirotian Pty. , Ltd.·Product code EKO·1990-12-05
K903722 — MICROMED QRS CARDNasiff Assoc., Inc.·Product code DPS·1990-12-05
K904050 — MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERAPhilips Medical Systems (Cleveland), Inc.·Product code IYX·1990-12-05
K904104 — ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCARETHICON, Inc.·Product code HET·1990-12-05
K904142 — GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERSBaxter Healthcare Corp·Product code HET·1990-12-05
K904151 — SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLESite Microsurgical Systems, Inc.·Product code HQC·1990-12-05
K904183 — SITE PHACOEMULSIFICATION HANDPIECESite Microsurgical Systems, Inc.·Product code HQC·1990-12-05
K904199 — HORIZON REGULAR ETCHING GELHorizon Chemical Co.·Product code EJR·1990-12-05
K904284 — ARTHROSCOPIC SURGICAL BLADESmith & Nephew Dyonics, Inc.·Product code HRX·1990-12-05
K904296 — LYSTA HYGIENIST III SCALERProdent Intl., Inc.·Product code ELC·1990-12-05
K904417 — CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEMDevice Labs, Inc.·Product code LJT·1990-12-05
K904844 — PRECISION HIP STEM WITH ADDITIONAL STEM SIZESHowmedica Corp.·Product code JDI·1990-12-05

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