FDA 510(k) clearances — page 1053

176,637 clearances on record, most recent first.

Clearances — page 1053

105,201–105,300 of 176,637

K944092 — ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEMOrthofix Srl·Product code JEC·1995-04-04
K945911 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARSBioclinical Systems, Inc.·Product code JTZ·1995-04-04
K950033 — POLYDERMWilshire Technologies·Product code LZA·1995-04-04
K950240 — LE CLEAN MACHINEParkell, Inc.·Product code ELC·1995-04-04
K950256 — TURBO 25/30Parkell, Inc.·Product code ELC·1995-04-04
K950288 — AUTOLASER MULTI FORMAT CAMERAAfp Imaging Corp.·Product code LMC·1995-04-04
K950461 — WELCH ALLYN OPHTHALMOSCOPEWelch Allyn, Inc.·Product code HLI·1995-04-04
K950982 — B. BRAUN SONOCAN BIOPSY NEEDLE AND ASPIRATION HANDLEB. Braun of America, Inc.·Product code FCG·1995-04-04
K951066 — RAINS FRONTAL SINUS STENTSmith & Nephew Richards, Inc.·Product code KAM·1995-04-04
K951209 — SUNGLASSESMainland Wholesale·Product code HQY·1995-04-04
K942245 — BIOWHITTAKER 2001 MICROPLATE READER FIRMWAREBiowhittaker Molecular Applications, Inc.·Product code JJQ·1995-04-03
K944309 — M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEMM.E.R. Surgical Co.·Product code GCJ·1995-04-03
K945224 — GRX FOAM DRESSINGGeritrex Corp.·Product code KMF·1995-04-03
K945962 — BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHYBennett X-Ray Corp.·Product code IZH·1995-04-03
K946104 — SMOKIEVAC ELECTROSURGICAL PENCILAspen Laboratories, Inc.·Product code GEI·1995-04-03
K946199 — AURAFLEX(R) ESTRADIOLOrganon Teknika Corp.·Product code CHP·1995-04-03
K950019 — THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100; LT-100Thermolase Corp.·Product code GEX·1995-04-03
K950072 — IMMULITE(R) TBGDiagnostic Products Corp.·Product code JJX·1995-04-03
K950192 — SKYTRON SKYBOOM SERIESSkytron, Div. the Kmw Group, Inc.·Product code FQO·1995-04-03
K950775 — CURASORB ZN ALGINATE WOUND DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health·Product code KMF·1995-04-03
K950883 — POLYDOROS SX 65 AND 80Siemens Medical Solutions USA, Inc.·Product code IZO·1995-04-03
K950981 — ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650Biodex Medical Systems, Inc.·Product code IXR·1995-04-03
K951003 — KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)Kenex , Ltd.·Product code KPY·1995-04-03
K951006 — KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)Kenex , Ltd.·Product code IXA·1995-04-03
K951251 — KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLEKARL STORZ Endoscopy-America, Inc.·Product code GCJ·1995-04-03
K926364 — ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X3M Health Care, Ltd.·Product code FRC·1995-03-31
K935676 — MICRO RSH HIGH SPEED HANDPIECEMicro Motors, Inc.·Product code EFB·1995-03-31
K941353 — MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEMElscint, Inc.·Product code IZH·1995-03-31
K942411 — R-MED DISPOSABLE PLUGR-Med, Inc.·Product code HET·1995-03-31
K944504 — CATCO FIRST PICCCatco Medical, Inc.·Product code FOZ·1995-03-31
K944685 — CATO FIRST PICC-DUAL LUMENCatco Medical, Inc.·Product code LJS·1995-03-31
K944844 — BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFTBaxter Healthcare Corp·Product code DYF·1995-03-31
K944873 — TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVESBaxter Healthcare Corp·Product code LYZ·1995-03-31
K945241 — LORAD M-IV, LORAD M-IVILorad Corp.·Product code IZH·1995-03-31
K945370 — C-POSTBisco, Inc.·Product code ELR·1995-03-31
K945652 — ATTENUATION CORRECTIONGE Medical Systems·Product code KPS·1995-03-31
K945743 — PREFERENCE MAMMOGRAPHY SYSTEMPhilips Medical Systems (Cleveland), Inc.·Product code IZH·1995-03-31
K946053 — SIMVIEW(TM) 3000Siemens Medical Solutions USA, Inc.·Product code KPQ·1995-03-31
K946240 — SCIMED(R) SCEPTOR(TM) PTCA GUIDE WIREScimed Life Systems, Inc.·Product code DQX·1995-03-31
K946260 — NTBS-1417, 1436, TBS-1417Scott Imaging Intl., Inc.·Product code IXY·1995-03-31
K946282 — UNIVERSAL URETHRAL CATHETERLouisville Laboratories, Inc.·Product code EZC·1995-03-31
K946356 — M-PATH NITINOL GUIDEWIREMicrovena Corp.·Product code DQX·1995-03-31
K950021 — REUSABLE TROCAR WITH SAFETY SLEEVEL.A.S.E.R., Inc.·Product code GCJ·1995-03-31
K950113 — SCIMED(R) CHICE(TM) EXCHANGE PTCA GUIDE WIREScimed Life Systems, Inc.·Product code DQX·1995-03-31
K950141 — SCIMED(R) CHOICE(TM) PTCA GUIDE WIREScimed Life Systems, Inc.·Product code DQX·1995-03-31
K950254 — CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVECypress Medical Products, Ltd.·Product code LYY·1995-03-31
K950402 — CORSINI 9090C.A.T. DI Corsini G. & C. Spa·Product code IXR·1995-03-31
K950442 — INFRARED EXPOSURE HAND SWITCHMedical X-Ray Intl., Inc.·Product code KXJ·1995-03-31
K950458 — SILVER ULTRA MINI CANALElectone, Inc.·Product code ESD·1995-03-31
K950571 — LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270Continental X-Ray Corp.·Product code IZF·1995-03-31
K950691 — MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AIDMiracle-Ear, Inc.·Product code ESD·1995-03-31
K950692 — MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AIDMiracle-Ear, Inc.·Product code ESD·1995-03-31
K950693 — MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AIDMiracle-Ear, Inc.·Product code ESD·1995-03-31
K950694 — COMPACT-XElectromed Intl., Ltd.·Product code IZO·1995-03-31
K950743 — ORAL PROCEDURE PACKTransidyne General Corp.·Product code EGS·1995-03-31
K950759 — UNITRON MODEL ESTEEMUnitron Industries, Inc.·Product code ESD·1995-03-31
K950773 — PROPHYLAXIS PACKTransidyne General Corp.·Product code EGS·1995-03-31
K950894 — SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)Argen Precious Metals, Inc.·Product code EJH·1995-03-31
K950965 — KARL STORZ STENT APPLICATOR FORCEPSKARL STORZ Endoscopy-America, Inc.·Product code EOQ·1995-03-31
K951045 — LASER GAS MIXTURELiquid Carbonic Industrial Gases·Product code GEX·1995-03-31
K951075 — S & C VINYL POLYSILOXANE IMPRESSION MATERIALS & C Polymer GmbH·Product code ELW·1995-03-31
K951111 — RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)Lifecore Biomedical, Inc.·Product code DZE·1995-03-31
K932769 — CAMINO VENTRICULAR DRAINAGE SYSTEMCamino Laboratories, Inc.·Product code JXG·1995-03-30
K934178 — ACCUSCREEN 17-HYDROXYPROGESTERONENeometrics, Inc.·Product code JLX·1995-03-30
K935449 — FOUNDATION NON-POROUS STEMEncore Orthopedics, Inc.·Product code JDI·1995-03-30
K942091 — OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANEOhmeda Medical·Product code CAD·1995-03-30
K945211 — KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAEKARL STORZ Endoscopy-America, Inc.·Product code HET·1995-03-30
K946387 — CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTERCapintec, Inc.·Product code JJJ·1995-03-30
K950016 — CART, MODE NUMBER UDS-CARTLaborie Medical Tech Corp.·Product code FEN·1995-03-30
K950135 — URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGEE.I. Dupont DE Nemours & Co., Inc.·Product code DKZ·1995-03-30
K950400 — HAND MASSAGE UNITUltrassage, Inc.·Product code IRO·1995-03-30
K950496 — SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIESBoston Scientific Corp·Product code FDI·1995-03-30
K950590 — REP CHOLESTEROL PROFILE CONTROLHelena Laboratories·Product code JJX·1995-03-30
K950801 — CARDIO REP LD CONTROL - CAT NO. 3325Helena Laboratories·Product code JJT·1995-03-30
K950902 — ALKO TONOMETERED SALINE CONTROLAlko Diagnostic Corp.·Product code JJS·1995-03-30
K931133 — CLINICAL INFOR SYST(CIS) W/FETAL MONIT REMOTE DISPClinicomp, Inc.·Product code HGM·1995-03-29
K936047 — SPECTRUM(TM) MASKRespironics, Inc.·Product code BZD·1995-03-29
K943603 — AESCULAP LAPAROSCOPIC ANCILLARY DEVICESAesculap, Inc.·Product code HET·1995-03-29
K944158 — STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACEMENTSteri-Oss, Inc.·Product code DZE·1995-03-29
K944824 — SUREWINGGainor Medical U.S.A., Inc.·Product code FPA·1995-03-29
K944968 — LANDMARK MIDLINE CATHETERMenlo Care, Inc.·Product code FOZ·1995-03-29
K945616 — CORDIS AVANTI CATHETER SHEATH INTRODUCERCordis Corp.·Product code DYB·1995-03-29
K945720 — JOSTRA HL-15 MODULAR HEART-LUNG MACHINE (HEREINAFTER CALLED THE HL-15 OR THE DEVICEJostra Bentley·Product code DWC·1995-03-29
K945977 — CENTURION(R) SITE GUARD(R) TRANSPARENT DRESSING/TRANSPAENT FILM DRESSINGTri-State Hospital Supply Corp.·Product code MGP·1995-03-29
K946338 — CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSINGCertified Safety Mfg., Inc.·Product code MGP·1995-03-29
K950277 — INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVERBoston Scientific Corp·Product code GCJ·1995-03-29
K950414 — HEMAGEN ENA SM/RMP KIT (EIA METHOD)Hemagen Diagnostics, Inc.·Product code LLL·1995-03-29
K950434 — KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHESKARL STORZ Endoscopy-America, Inc.·Product code OCZ·1995-03-29
K950491 — RICH-MAR CARBON ELECTRODESRich-Mar Corp.·Product code GXY·1995-03-29
K950581 — SMART ANESTHESIA MULTI-GAS (SAM) MODULEMarquette Electronics, Inc.·Product code CCK·1995-03-29
K950737 — LANDMARK MIDLINE CATHETERMenlo Care, Inc.·Product code FOZ·1995-03-29
K950985 — ZEISS ENDOLIVE STERO ENDOSCOPECarl Zeiss, Inc.·Product code GCJ·1995-03-29
K924997 — EDDArc Medical, Inc.·Product code BTR·1995-03-28
K932866 — RESOLUT REGENERATIVE MATERIALW. L. Gore & Associates, Inc.·Product code LYC·1995-03-28
K942483 — CLINICAL GLASS THERMOMETERMakol Medical Instruments Corp.·Product code FLK·1995-03-28
K942931 — STATLOCK SECUREMENT DEVICESVenetec, Inc.·Product code FPA·1995-03-28
K944313 — SPECTACLE FRAMESun Hing Optical Manufactory , Ltd.·Product code HQZ·1995-03-28
K944765 — KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPSKARL STORZ Endoscopy-America, Inc.·Product code KGE·1995-03-28
K945656 — THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPEMicro-Medical Devices, Inc.·Product code KKX·1995-03-28
K946328 — TDX(R)/TDXFLX(R) PHENYTOIN IIAbbott Laboratories·Product code LGR·1995-03-28

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