FDA 510(k) clearances — page 869

176,637 clearances on record, most recent first.

Clearances — page 869

86,801–86,900 of 176,637

K990712 — OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEMHowmedica Osteonics Corp.·Product code MJT·1999-07-20
K991416 — ENDOSCOPIC CAMERAGenzyme Surgical Product (Genzyme Biosurgery)·Product code GCJ·1999-07-20
K991464 — DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50Fisma, Inc.·Product code GEX·1999-07-20
K991469 — AWARE PADAac Consulting Group, Inc.·Product code IYO·1999-07-20
K991525 — DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFFDeroyal Industries, Inc.·Product code DXQ·1999-07-20
K991608 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.·Product code KMF·1999-07-20
K991609 — DERMAPHYLYX SUPER ABSORBENT FIBER DRESSINGDermaphylyx, Inc.·Product code KMF·1999-07-20
K991636 — ELEKTA STEREOTACTIC GUIDEElekta Instrument AB·Product code HAW·1999-07-20
K991860 — SYNTHES CRANIAL FLAP TWIST CLAMPSynthes (Usa)·Product code GXN·1999-07-20
K991865 — Q-LITE 75 LIGHT CURE UNITRolence Enterprise Co. , Ltd.·Product code EBZ·1999-07-20
K991957 — CICACARE MANAGEMENT FOR SCARSSmith & Nephew, Inc.·Product code MDA·1999-07-20
K992000 — SYNTHES CRANIAL FLAP TUBE CLAMPSynthes (Usa)·Product code GXN·1999-07-20
K990597 — SUMMER'S EVE LUBRICATING JELLYC.B. Fleet Co., Inc.·Product code HIS·1999-07-19
K991104 — MICROTOOLSConception Technology, Inc.·Product code MQH·1999-07-19
K991173 — <GENX> FERTILIZATION MEDIA-HTF<Genx> Intl., Inc.·Product code MQL·1999-07-19
K991367 — MEDITRON STETHOSCOPE SYSTEMMeditron AS·Product code DQD·1999-07-19
K991408 — FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATORThermoquest Corp.·Product code MQG·1999-07-19
K991568 — MR SPECTROSCOPY PACKAGEPhilips Medical Systems (Cleveland), Inc.·Product code LNI·1999-07-19
K991700 — SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZOSwemed Lab International AB·Product code MQH·1999-07-19
K991827 — GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043Ri Mos. S.R.L.·Product code HIB·1999-07-19
K991863 — CUTE-LITE I LIGHT CURE UNITRolence Enterprise Co. , Ltd.·Product code EBZ·1999-07-19
K991403 — SOLO-CARE BRAND MULTI-PURPOSE SOLUTIONCiba Vision Corporation·Product code LPN·1999-07-16
K991514 — GEBAUER'S CHLORIDE FINE NOZZEGebauer Co.·Product code MLY·1999-07-16
K991727 — STAT PROFILE M7 ANALYZERNova Biomedical Corp.·Product code CGL·1999-07-16
K983940 — EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATORAdam Spence Corp.·Product code DYB·1999-07-15
K984528 — PARKER FLEX-TIP TRACHEAL TUBEParker Medical Assoc.·Product code BTR·1999-07-15
K990304 — MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEMAstra Tech, Inc.·Product code DZE·1999-07-15
K990524 — E9000 SYSTEMLinvatec Corp.·Product code HRX·1999-07-15
K990681 — DBSET MULTIDRUG SCREEN TEST KITAmeritek, Inc.·Product code DKZ·1999-07-15
K990820 — RAPIDONE - OPIATES TESTAmerican Bio Medica Corp.·Product code DJG·1999-07-15
K990822 — RAPIDONE - COCAINE TESTAmerican Bio Medica Corp.·Product code DIO·1999-07-15
K991001 — MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETEREp Medsystems·Product code DRF·1999-07-15
K991382 — SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101Genicon, LC·Product code GCJ·1999-07-15
K991389 — ANORECTAL MANOMETRY SUITE, MODEL 9032S0201Medtronic Functional Diagnostics A/S·Product code FFX·1999-07-15
K991489 — ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)Harry J. Bosworth Co.·Product code ELW·1999-07-15
K991490 — ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)Harry J. Bosworth Co.·Product code ELW·1999-07-15
K991694 — DYNAREX DRAIN SPONGEDynarex Corp.·Product code KMF·1999-07-15
K991695 — DYNAREX NON-WOVEN SPONGEDynarex Corp.·Product code KMF·1999-07-15
K991705 — N PROTEIN STANDARD UYDade Behring, Inc.·Product code JIT·1999-07-15
K992122 — TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVEMaxxim Medical·Product code LYZ·1999-07-15
K980380 — NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MSDiametrics Medical, Ltd.·Product code GWM·1999-07-14
K983660 — EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)Brainlab, Inc.·Product code LHN·1999-07-14
K984563 — THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPYAccuray, Inc.·Product code IWB·1999-07-14
K990068 — SOLAR 9500 INFORMATION MONITORGeneral Electric Medical Systems Information Techn·Product code MHX·1999-07-14
K990341 — ELECTRO MECHANICAL LITHOTRIPTORNorthgate Technologies, Inc.·Product code FFK·1999-07-14
K990847 — INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING MHumagen Fertility Diagnostics, Inc.·Product code MQH·1999-07-14
K990941 — NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452LHumagen Fertility Diagnostics, Inc.·Product code MQK·1999-07-14
K991114 — REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMLifecore Biomedical, Inc.·Product code DZE·1999-07-14
K991291 — STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATIONConway Stuart Medical, Inc.·Product code GEI·1999-07-14
K991338 — BOVINE SERUM ALBUMIN (BSA)Irvine Scientific Sales Co., Inc.·Product code MQL·1999-07-14
K991343 — PVP (POLYVINYLPYRROLIDONE)Irvine Scientific Sales Co., Inc.·Product code MQL·1999-07-14
K991477 — SPIN SNAP-OFF SCREWNew Deal, S.A.·Product code HWC·1999-07-14
K991500 — SMITH & NEPHEW SUTURE LOKSmith & Nephew Endoscopy, Inc.·Product code OCW·1999-07-14
K991509 — PRO-PORTION CLEANER/DISINFECTANTSultan Chemists, Inc.·Product code LRJ·1999-07-14
K991567 — SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.Shelhigh, Inc.·Product code FTM·1999-07-14
K991616 — CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)Hartalega Sdn Bhd·Product code LYY·1999-07-14
K991622 — 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINERStelkast Company·Product code JDI·1999-07-14
K991649 — DEPUY ROCKWOOD CLAVICLE PINDepuy, Inc.·Product code JDW·1999-07-14
K991869 — COBREX HIP STEM, MODEL 01-128-XXXXXImplex Corp.·Product code JDI·1999-07-14
K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINEConsolidated Technologies, Inc.·Product code LAS·1999-07-14
K972772 — ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTINGTrek Diagnostic Systems, Inc.·Product code MJA·1999-07-13
K990872 — SCLERAL PLUGS, 19 AND 20 GAUGEOphthalmic Consultants, Inc.·Product code LXP·1999-07-13
K991072 — AHMED GLAUCOMA VALVE IMPLANTNew World Medical, Inc.·Product code KYF·1999-07-13
K991560 — NASO-LARYNGO-PHARYNGOSCOPEFiber Imaging Technologies, Inc.·Product code EOB·1999-07-13
K991733 — ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLSSchiapparelli Biosystems, Inc.·Product code MRR·1999-07-13
K991992 — ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVESAllegiance Healthcare Corp.·Product code KGO·1999-07-13
K992163 — ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMSPdz-Europa , Ltd.·Product code DOP·1999-07-13
K992217 — AT HOME DRUG TEST, MODEL 9175Phamatech·Product code MVO·1999-07-13
K982326 — MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGYBoston Scientific Corp·Product code MSD·1999-07-12
K982943 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000Transtracheal Systems·Product code NFB·1999-07-12
K983203 — IMMULITE EPO, MODEL #'S LKEPZ & LKEP1Diagnostic Products Corp.·Product code GGT·1999-07-12
K984512 — NITRILON CORRECT-TOUCHCt Intl.·Product code KGO·1999-07-12
K984639 — THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCERMedison America, Inc.·Product code ITX·1999-07-12
K990135 — TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENEZimmer, Inc.·Product code LPH·1999-07-12
K990237 — TROCAR SYSTEM ACCORDING TO HASSONOlympus America, Inc.·Product code GCJ·1999-07-12
K990719 — EARLOOP FACE MASKShuenn Bao Shing Corp.·Product code FXX·1999-07-12
K991267 — SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING AOhio Medical Instrument Co., Inc.·Product code HAW·1999-07-12
K991272 — CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND EGalil Medical , Ltd.·Product code GEH·1999-07-12
K991276 — PASS/FAIL CHALLENGE PACKPropper Mfg. Co., Inc.·Product code JOJ·1999-07-12
K991285 — LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODEAesculap-Meditec North America·Product code GEX·1999-07-12
K991297 — UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIESMedart Corp.·Product code GEX·1999-07-12
K991300 — BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICEDhd Healthcare Corp.·Product code BWF·1999-07-12
K991303 — VISTA ORPC WITH INFOMATIX INTRAOP SOFTWAREVista Medical Technologies, Inc.·Product code GCJ·1999-07-12
K991336 — BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPYMedical Instrumentation & Diagnostics Corp.(Midco)·Product code IYE·1999-07-12
K991377 — OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLEROmnisonics Medical Technologies·Product code GCJ·1999-07-12
K991400 — PARIETENE POLYPROPYLENE MESHSofradim Production·Product code FTL·1999-07-12
K991485 — SYNERGY POROUS SIZE 8 HIP STEMSmith & Nephew, Inc.·Product code LPH·1999-07-12
K991650 — CMV BRITE TURBO KITBiotest Diagnostics Corp.·Product code LIN·1999-07-12
K991900 — XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40Excel Tech. , Ltd.·Product code OLV·1999-07-12
K991917 — OSTEOMARK NTX POINT OF CARE (POC) CONTROL SETMetrika, Inc.·Product code JJW·1999-07-12
K991940 — BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)Brightway Holdings Sdn. Bhd.·Product code KGO·1999-07-12
K992031 — LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN)Shanghai Changzheng Latex Factory·Product code LYY·1999-07-12
K992065 — GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEADDePuy Orthopaedics, Inc.·Product code KWS·1999-07-12
K992083 — SCATTERFREE LATERAL EMITTING FIBERLaser Peripherals, LLC·Product code GEX·1999-07-12
K992084 — CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASERCynosure, Inc.·Product code GEX·1999-07-12
K992191 — ETI-EA-G ASSAYDiaSorin, Inc.·Product code LSE·1999-07-12
K992208 — GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEMGe Medical Systems, Inc.·Product code IYO·1999-07-12
K992230 — OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HPTrimedyne, Inc.·Product code GEX·1999-07-12
K983504 — PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST STMedisense, Inc.·Product code CGA·1999-07-09
K984295 — INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)Invacare Corp.·Product code CCL·1999-07-09

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