FDA 510(k) clearances — page 904

176,637 clearances on record, most recent first.

Clearances — page 904

90,301–90,400 of 176,637

K980962 — BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPROBrennen Medical, Inc.·Product code MGQ·1998-07-29
K981715 — DISTAL RADIUS FRACTURE FIXATION PLATEAvanta Orthopaedics, Inc.·Product code HRS·1998-07-29
K981775 — DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATEDepuy Ace Medical Co.·Product code HRS·1998-07-29
K981794 — HICHEM CALCIUM REAGENT KITHichem Diagnostics·Product code CJY·1998-07-29
K981821 — VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORAngiolaz, Inc.·Product code FSS·1998-07-29
K981856 — MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)Greatbatch Scientific·Product code FET·1998-07-29
K981857 — QUANTA LITE TPO ELISAInova Diagnostics, Inc.·Product code LLL·1998-07-29
K981941 — MULTAPORT CANNULA REDUCER AND ACCESSORIESDexide, Inc.·Product code GCJ·1998-07-29
K982156 — PASCO MIC AND MIC/ID PANELS/ CEFDINIRPasco Laboratories, Inc.·Product code JWJ·1998-07-29
K982211 — PROFILE-II MODEL 600582Medtox Diagnostics, Inc.·Product code DKE·1998-07-29
K982222 — SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEMSynthes (Usa)·Product code HWC·1998-07-29
K982351 — LUNAStellate Systems·Product code OLT·1998-07-29
K982443 — DOC VENTRAL CERVICAL STABILIZATION SYSTEMDepuy Motech Acromed·Product code KWQ·1998-07-29
K980094 — MODIFICATION TO THE OXYCONALPHAErich Jaeger B.V.·Product code BTY·1998-07-28
K980158 — MYO-TRAIN V (5)Sterne Equipment Co., Ltd.·Product code IPF·1998-07-28
K981601 — CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETERSorin Group Italia S.R.L.·Product code DWF·1998-07-28
K981618 — LIQUID AHarry J. Bosworth Co.·Product code EMA·1998-07-28
K981631 — INFLUENCE CLIP SYSTEMInfluence, Inc.·Product code FZP·1998-07-28
K981673 — POWDERFREE GREEN NITRILE EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.·Product code LZA·1998-07-28
K981674 — POWDERED GREEN NITRILE EXAMINATION GLOVESBesglove Medicare Sdn. Bhd.·Product code LZA·1998-07-28
K981675 — POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)Besglove Medicare Sdn. Bhd.·Product code LZA·1998-07-28
K981683 — HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01YVenusa , Ltd.·Product code FPA·1998-07-28
K981721 — C0-AXIAL INTRODUCER NEEDLEInrad·Product code KNW·1998-07-28
K981827 — VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEMAngiolaz, Inc.·Product code FET·1998-07-28
K981918 — UREAAbbott Laboratories·Product code CDQ·1998-07-28
K981951 — CT 100 ELECTROCARDIOGRAPHMacquarie Medical Systems·Product code DPS·1998-07-28
K973636 — MCS-MEDICATED CANAL SEALERDr. Howard Martin, P.A.·Product code EMA·1998-07-27
K980526 — PHOTON RADIOSURGERY SYSTEM PRS400Pec Photoelectron Corp.·Product code JAD·1998-07-27
K981434 — EUP-OL334 LAPARASCOPICPROBEHitachi Medical Corp. of America·Product code ITX·1998-07-27
K981692 — MENISCAL REPAIR DEVICELinvatec Corp.·Product code MBI·1998-07-27
K982048 — MPS RESERVOIR BAGMedical Product Specialists·Product code KPE·1998-07-27
K974445 — 3M RED DOT RESTING EKG ELECTRODE, CATALOG 23603M Healthcare·Product code DRX·1998-07-26
K982232 — MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEMIrvine Biomedical, Inc.·Product code DRF·1998-07-25
K972817 — RESOR-PIN RESORBABLE MEMBRANE PINGeistlich-Pharma·Product code LYC·1998-07-24
K980128 — BALADI INVERTER WITH COAXIAL AORTIC PUNCHCardio Medical Solutions, Inc.·Product code DXC·1998-07-24
K981112 — MOBETRONIntraop Medical, Inc.·Product code LHN·1998-07-24
K981511 — OTO WIZZARDMedrx, Inc.·Product code EWO·1998-07-24
K981561 — LIQUID ENZYME ID 90133Alcon Laboratories·Product code LPN·1998-07-24
K981736 — BACT/ALERT 3D MICROBIAL DETECTION SYSTEMOrganon Teknika Corp.·Product code MDB·1998-07-24
K981741 — CARRIAZO BARRAQUER MICROKERATOMEMoria, Inc.·Product code HMY·1998-07-24
K981774 — MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCEPwa Industries Sdn. Bhd.·Product code LYY·1998-07-24
K981804 — XENON LIGHT SOURCE MODEL LS6000Contec Medical Vision, Ltd.·Product code GCT·1998-07-24
K981963 — SENSITEX EXAMINATION GLOVEOak Carolina, Inc.·Product code LYZ·1998-07-24
K982118 — CARESIDE ANALYZERExigent Diagnostics, Inc.·Product code CHH·1998-07-24
K970679 — ALTRA FLUX 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl·Product code MSF·1998-07-23
K970681 — ALTRA NOVA 200 HEMODIALYZERAlthin Medical AB an Affiliate of Baxter Intl·Product code MSF·1998-07-23
K973347 — TSX PRM PULMONARY RESUSCITATION MONITORSpiracle Technology·Product code CAP·1998-07-23
K981071 — ML MICROKERATOMEMed-Logics, Inc.·Product code HNO·1998-07-23
K981078 — TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000Transtracheal Systems·Product code CAW·1998-07-23
K981534 — VIPERCAMIntegra Medical·Product code EIA·1998-07-23
K981708 — DENTAL PORCELAIN-VARIOUSExcel Porcelain Products·Product code FLL·1998-07-23
K982269 — CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA AND 27GAAllegiance Healthcare Corp.·Product code MIA·1998-07-23
K971322 — CORE AND COIL ASSEMBLY GUIDEWIRELake Region Mfg., Inc.·Product code DQX·1998-07-22
K972908 — SANDS SERIES III HYPERBARIC CHAMBERSands Hyperbarics·Product code CBF·1998-07-22
K973154 — UBI MAGIWEL MARIJUANA METABOLITESUnited Biotech, Inc.·Product code LDJ·1998-07-22
K973456 — SPIROBANK PORTABLE PC BASED SPIROMETERFuturemed America, Inc.·Product code BZG·1998-07-22
K974343 — DADE INNOVINDade Intl., Inc.·Product code GJS·1998-07-22
K980365 — GOODKNIGHT 418 CPAP SYSTEMNellcor Puritan Bennett, Inc.·Product code BZD·1998-07-22
K980522 — REFRACTEC MCS-100Refractec, Inc.·Product code HQR·1998-07-22
K980596 — VCA IGM ELISA TEST SYSTEMClark Laboratories, Inc.·Product code LSE·1998-07-22
K980635 — DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37Dako Corp.·Product code GKZ·1998-07-22
K980912 — VCA IGG ELISA TEST SYSTEMClark Laboratories, Inc.·Product code LSE·1998-07-22
K980966 — SUPERGLOVES POWDERED NITRILESupermax Sdn Bhd·Product code LZA·1998-07-22
K981083 — RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000Biotronik, Inc.·Product code DTB·1998-07-22
K981444 — BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIPPrinceton BioMeditech Corp.·Product code JHI·1998-07-22
K981493 — MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220Polymer Technology Systems, Inc.·Product code CHH·1998-07-22
K981654 — TIBCAbbott Laboratories·Product code JMO·1998-07-22
K981748 — WIELISA ANCA SCREENING KIT TEST SYSTEMWieslab AB·Product code MOB·1998-07-22
K981750 — WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEMWieslab AB·Product code MOB·1998-07-22
K981760 — PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598Playtime Products, Inc.·Product code HEB·1998-07-22
K981799 — CREAAbbott Laboratories·Product code CGX·1998-07-22
K981814 — ALBPAbbott Laboratories·Product code CJW·1998-07-22
K981920 — AMMAbbott Laboratories·Product code JIF·1998-07-22
K981926 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSEmd Chemicals, Inc.·Product code DLJ·1998-07-22
K981943 — DBILAbbott Laboratories·Product code CIG·1998-07-22
K981978 — AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATORPointe Scientific, Inc.,·Product code MRR·1998-07-22
K982007 — TRUBYTE DENTURE BOND DENTURE BONDING AGENTDentsply Intl.·Product code KLE·1998-07-22
K982094 — VERABOND 2Aalba Dent, Inc.·Product code EJH·1998-07-22
K982277 — MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)Nova Biomedical Corp.·Product code CHL·1998-07-22
K982290 — CHEM-CHEX STAT (NEW)Streck Laboratories, Inc.·Product code JJY·1998-07-22
K970712 — LAPARO-TENSERL & T S.N.C. DI E. Lucini & C.·Product code HET·1998-07-21
K971084 — MODEL 02 OXYGEN ANALYZEROxigraf, Inc.·Product code CCL·1998-07-21
K974200 — ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEMOrca Diagnostics Corp.·Product code BZM·1998-07-21
K980290 — ITI STENTIntratherapeutics, Inc.·Product code FGE·1998-07-21
K980517 — EPILASER NORMAL MODE RUBY LASERPalomar Medical Products, Inc.·Product code GEX·1998-07-21
K982047 — MPS HUBER NEEDLE EXTENSION SETMedical Product Specialists·Product code FPA·1998-07-21
K982123 — CONTRAST CONTROL DEVICEMedex, Inc.·Product code FPA·1998-07-21
K982184 — WALLSTENT ENDOPROSTHESISBoston Scientific Scimed, Inc.·Product code JCT·1998-07-21
K980302 — WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPESRichard Wolf Medical Instruments Corp.·Product code HIH·1998-07-20
K980648 — PRO VISIONAlgotec Systems, Ltd.·Product code LLZ·1998-07-20
K981029 — BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.·Product code MOB·1998-07-20
K981030 — BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KITThe Binding Site, Ltd.·Product code MOB·1998-07-20
K981438 — DORNIER MEDILAS EDornier Surgical Products, Inc.·Product code GEX·1998-07-20
K981637 — INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGYLinvatec Corp.·Product code ERL·1998-07-20
K982231 — STATUSFLOWR&D Systems, Inc.·Product code GKZ·1998-07-20
DEN980003 — DIAMOND PROBE/PERIO 2000 SYSTEMDiamond General Development Corp.·Product code MVH·1998-07-17
K970069 — DUAL HOOK FIBEROPTIC DELIVERY SYSTEMIhd, Inc.·Product code GEX·1998-07-17
K972575 — 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICESLaserscope·Product code GEX·1998-07-17
K972846 — BMC RF CANNULABaylis Medical Co., Inc.·Product code GXI·1998-07-17
K973430 — KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEMEastman Kodak Company·Product code GCJ·1998-07-17

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