FDA 510(k) clearances — page 1254

176,637 clearances on record, most recent first.

Clearances — page 1254

125,301–125,400 of 176,637

K885037 — AMUKIN 50% - AIRSPRAY(R)Bernard J. Cooney, P.A.·Product code FKO·1990-10-19
K896813 — MODIFIED INTRAVENOUS CATHETERSafeguard Needle Co.·Product code FOZ·1990-10-19
K900710 — INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETERIntec Medical, Inc.·Product code KRB·1990-10-19
K901627 — ARTERIAL EMBOLECTOMY CATHETERApplied Vascular Devices, Inc.·Product code DXE·1990-10-19
K902109 — STATLOCK IV CONNECTOR AND ANCHOR SETVenetec, Inc.·Product code FPA·1990-10-19
K903216 — THE GUIDER CORONARY GUIDING CATHETERIntec Medical, Inc.·Product code DQY·1990-10-19
K903217 — TAPERED TIP THE GUIDER CORONARY GUIDING CATHETERIntec Medical, Inc.·Product code DQY·1990-10-19
K903292 — ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALSCoe Laboratories, Inc.·Product code ELW·1990-10-19
K903312 — CYGNASCOPECygnus Instruments, Inc.·Product code HRX·1990-10-19
K903379 — PYMAH PRE-GAGED BALANCED TEMPA-KUFFPymah Corp.·Product code DXQ·1990-10-19
K903436 — SARNS MEMBRANE OXGENATOR PART NUMBER 94433M Health Care, Sarns·Product code DTZ·1990-10-19
K903457 — PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER)Precise Optics·Product code FET·1990-10-19
K903458 — PRECISION OPTICS IMAGE COUPLERPrecise Optics·Product code FET·1990-10-19
K903533 — STERI-SHIELDBiomedical Devices, Inc.·Product code FXY·1990-10-19
K903610 — O.R. TIP CLEANERInman Liebelt Corp.·Product code GEI·1990-10-19
K903702 — MODEL 90421 FLEXPORT INTERFACESpacelabs, Inc.·Product code DQA·1990-10-19
K903769 — PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOONDatascope Corp.·Product code DSP·1990-10-19
K903851 — CLUB FOOT CPM MACHINESmith & Nephew Richards, Inc.·Product code BXB·1990-10-19
K903867 — DATASCOPE PERCOR STAT DL 10.5 FR 40CCDatascope Corp.·Product code DSP·1990-10-19
K903892 — DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BALDatascope Corp.·Product code DSP·1990-10-19
K903893 — DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BALDatascope Corp.·Product code DSP·1990-10-19
K903994 — URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTIONApplied Urology, Inc.·Product code FGF·1990-10-19
K904018 — DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BALDatascope Corp.·Product code DSP·1990-10-19
K904162 — CARBON DIOXIDE FLOWTHROUGH LASER MIXTURESNorco, Inc.·Product code GEX·1990-10-19
K904340 — FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEMNeoligaments, Ltd.·Product code JDR·1990-10-19
K904366 — CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATORDouglas James Donaldson Compliance Services·Product code HQF·1990-10-19
K904641 — LATEX EXAMINATION GLOVES(MFG: MODLOOK INDUSTRIES)Predex Co. , Ltd.·Product code LYY·1990-10-19
K904642 — VINYL EXAMINATION GLOVES(MFG:KAO YING INDUSTRIAL)Predex Co. , Ltd.·Product code LYZ·1990-10-19
K903206 — AUTO SUTURE(R) ENDOSCOPIC SCISSORSUnited States Surgical, A Division of Tyco Healthc·Product code HET·1990-10-17
K903494 — MAINTENACE FLOW - ACCESORY DEVICE FOR CAVROPUMPLife-Tech Intl., Inc.·Product code DXT·1990-10-17
K903598 — ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-NDixon Medical, Inc.·Product code HET·1990-10-17
K903599 — ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-NDixon Medical, Inc.·Product code HET·1990-10-17
K903600 — ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-NDixon Medical, Inc.·Product code HET·1990-10-17
K903912 — KERATOMEMicro Precision Instrument Co.·Product code HNO·1990-10-17
K904077 — VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEMMed Institute, Inc.·Product code LJT·1990-10-17
K904170 — PCA (R) TIBIAL BONE WEDGESHowmedica Corp.·Product code JWH·1990-10-17
K904300 — INSET PATELLAR COMPONENTJohnson & Johnson Orthopaedics, Inc.·Product code JWH·1990-10-17
K904351 — FOCUS COBALT CHROMIUM TOTAL HIPDepuy, Inc.·Product code JDI·1990-10-17
K904382 — SAFE-T-STIKXikon Technology·Product code FMF·1990-10-17
K904443 — PATIENT EXAMINATION GLOVESPisak Enterprise Co., Ltd.·Product code LYY·1990-10-17
K904447 — SONY CINE VIDEO SYSTEM SME-3500Sony Medical Electronics Co.·Product code IZI·1990-10-17
K904518 — VOLUMETRIC INFUSION PUMPKendall Mcgaw Laboratories, Inc.·Product code FRN·1990-10-17
K897106 — MEDI-TECH DILATATION CATHETERS ULTRA THIN IIBoston Scientific Corp·Product code LIT·1990-10-16
K900607 — MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11Cardiodata Corp.·Product code DSI·1990-10-16
K902143 — FOGARTY VESSEL CALIBRATORBaxter Healthcare Corp·Product code DWP·1990-10-16
K902342 — UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491Medtronic Vascular·Product code LDF·1990-10-16
K902518 — LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICEPall Biomedical Products Co.·Product code DTM·1990-10-16
K902932 — DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABLDatascope Corp.·Product code DYB·1990-10-16
K903324 — TOXO IGM ELISA TESTGull Laboratories, Inc.·Product code LGD·1990-10-16
K903405 — CHLAMYDIA ACCU-CULSHURE TMMedical Laboratory Automation Systems, Inc.·Product code LIO·1990-10-16
K903406 — VIRAL ACCU-CULSHURE TMMedical Laboratory Automation Systems, Inc.·Product code LIO·1990-10-16
K903462 — OPTIMED GLAUCOMA PRESSURE REGULATOROptimed, Inc.·Product code KYF·1990-10-16
K903612 — EBV/EA-CHECK TM TEST KITDiagnostic Technology, Inc.·Product code LSE·1990-10-16
K903687 — TURBIQUANT MYOGLOBINBehring Diagnostics, Inc.·Product code DDR·1990-10-16
K903810 — ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREWAce Medical Co.·Product code HWC·1990-10-16
K903811 — ACE CANNULATED CORTICAL BONE SCREWAce Medical Co.·Product code HWC·1990-10-16
K903840 — GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSYIntec Medical, Inc.·Product code DYB·1990-10-16
K903927 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UPBiotronik, GmbH & Co.·Product code DTB·1990-10-16
K903928 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UPBiotronik, GmbH & Co.·Product code DTB·1990-10-16
K903929 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UPBiotronik, GmbH & Co.·Product code DTB·1990-10-16
K904036 — BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGENBaxter Healthcare Corp·Product code LIN·1990-10-16
K904263 — DACRON R SURGICAL SUTURESSharppoint, Inc.·Product code GAS·1990-10-16
K904400 — MERIFLUOR TM PNEUMOCYSTIS MODIFICATIONMeridian Diagnostics, Inc.·Product code LYF·1990-10-16
K902161 — DEMISTIFIER ISOLATION CHAMBERPeace Medical, Inc.·Product code CBN·1990-10-15
K902906 — GAS-VAK(R) COMBINATION STERILIZER & VENTILATORGas-Vak·Product code FLI·1990-10-15
K903191 — QUICK CHECK 3 FILMQuantai Biotronics, Inc.·Product code CGA·1990-10-15
K903378 — MODEL C286 ISOLETTE INFANT INCUBATORAir-Shields Vickers, Inc.·Product code FMZ·1990-10-15
K903626 — BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, Inc.·Product code JJG·1990-10-15
K903668 — WILSON-COOK ASPIRATION HANDLEWilson-Cook Medical, Inc.·Product code FBK·1990-10-15
K903738 — QUIDEL ALLERGEN SCREEN POSITIVE CONTROLQuidel Corp.·Product code DGC·1990-10-15
K903742 — ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGEDiagnostic Products Corp.·Product code DHB·1990-10-15
K904016 — MAXI TESTBhc Biotech , Ltd.·Product code JHI·1990-10-15
K904100 — DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300)Diagnostic Systems Laboratories, Inc.·Product code CDZ·1990-10-15
K904105 — V-TREND TARGET RF TESTTexas Immunology, Inc.·Product code DHR·1990-10-15
K904168 — ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEMBoehringer Mannheim Corp.·Product code CGA·1990-10-15
K904220 — SYNCHRON CX4-CEBeckman·Product code JJE·1990-10-15
K904224 — NOVA LITE TM THYROIDInova Diagnostics, Inc.·Product code JZO·1990-10-15
K904252 — HEATWAVEMedadvances, Inc.·Product code LGZ·1990-10-15
K904295 — PROGUARD(TM) BLOOD COLLECTION NEEDLESafety-Ject, Inc.·Product code FMI·1990-10-15
K904305 — DUPONT DIMENSION(R) GENTAMICIN(GENT) METHODE.I. Dupont DE Nemours & Co., Inc.·Product code LCD·1990-10-15
K904306 — DUPONT DRUG CALIBRATOR-AE.I. Dupont DE Nemours & Co., Inc.·Product code JJX·1990-10-15
K904489 — EUREKA EXTENSION CYLINDERSEureka X-Ray Tube Corp.·Product code KPW·1990-10-15
K902164 — SYB, OR SAVE YOUR BREATH TONGUE CLEANERP.J., Inc.·Product code LCN·1990-10-12
K902240 — VET (VACUUM ERECTION TECHNOLOGY)Vetco, Inc.·Product code LKY·1990-10-12
K902533 — PULSED SELECTRONNucletron-Oldelft Corp.·Product code JAQ·1990-10-12
K902786 — MILENIA (TM) LHDiagnostic Products Corp.·Product code CEP·1990-10-12
K903124 — LAPAROSCOPIC ACCESS SHEATH SETCook, Inc.·Product code HET·1990-10-12
K903146 — HYSTEROSCOPY SHEATH SETCook, Inc.·Product code HIH·1990-10-12
K903187 — LAPAROSCOPIC CATHERTERCook Ob/Gyn·Product code HET·1990-10-12
K903235 — STATLAB A-350 SALIVA ALCOHOL TESTEnzymatics C/O Burditt,Bowles,Radzius & Ruberry·Product code DIC·1990-10-12
K903286 — CONTINUUM KNEE SYSTEM (CKS)-MODIFICATIONTechmedica, Inc.·Product code HSX·1990-10-12
K903304 — ROCHE COBAS READY GGT REAGENTRoche Diagnostic Systems, Inc.·Product code JPZ·1990-10-12
K903391 — ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMMNichols Institute·Product code JLW·1990-10-12
K903396 — IL T UPTAKE ASSAY SYSTEMInstrumentation Laboratory CO·Product code KHQ·1990-10-12
K903433 — TDX FREE T3 CALCULATIONAbbott Laboratories·Product code CDP·1990-10-12
K903465 — IR-192 IMPLANTRads S.L., Inc.·Product code KXK·1990-10-12
K903543 — SYNERMED ALBUMIN REAGENT KITSynermed, Inc.·Product code CIX·1990-10-12
K903608 — V-LINKGE Medical Systems·Product code CAW·1990-10-12
K903620 — MODIFIED ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEMSmith & Nephew Dyonics, Inc.·Product code HRX·1990-10-12
K903691 — A-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EX.Therex Corp.·Product code LJT·1990-10-12

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