FDA 510(k) clearances — page 900

176,637 clearances on record, most recent first.

Clearances — page 900

89,901–90,000 of 176,637

K982517 — CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1998-09-09
K982519 — LEVOFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1998-09-09
K982520 — CEFONICID ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1998-09-09
K982523 — SULFISOXAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1998-09-09
K982524 — AMOXICILLIN/CLAVULANIC ACID ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1998-09-09
K982526 — SPARFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1998-09-09
K982528 — NAFCILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1998-09-09
K982669 — OXOID STREPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1998-09-09
K982735 — LIGHT SABER BONE BIOPSY NEEDLEMinrad, Inc.·Product code KNW·1998-09-09
K982929 — MAXAIR NASAL DILATOR SYSTEMHnl Technologies·Product code LWF·1998-09-09
K974352 — CARDIOVIEW 3000 SOFTWAREMicromedical, Inc.·Product code LOS·1998-09-08
K980457 — ENDO ABSORBABLE INTERFERENCE SCREWEndo Surgical Concepts, Inc.·Product code HWC·1998-09-08
K981095 — ALIGN SYSTEMAlign Technology·Product code NXC·1998-09-08
K982031 — OCULIGHT GL WITH THE DERMATOLOGY HANDPIECEIridex Corp·Product code GEX·1998-09-08
K982040 — MEDPOR SURGICAL GRANULE IMPLANTSPorex Surgical, Inc.·Product code GXP·1998-09-08
K982042 — ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002Island Biosurgical, Inc.·Product code OTN·1998-09-08
K982055 — ACCUPROBE 800 SERIES MODEL NUMBERS : 810, 820, 830, 840, 850, 860, 870 AND 880Cryomedical Sciences, Inc.·Product code GEH·1998-09-08
K982116 — AQUACEL HYDROFIBER WOUND DRESSINGConvatec, A Bristol-Myers Squibb Co.·Product code KMF·1998-09-08
K982234 — AL-GEN CALCIUM ALGINATE DRESSINGInnovative Technologies , Ltd.·Product code KMF·1998-09-08
K982258 — MAMMARY SIZERSpecialty Surgical Products, Inc.·Product code MRD·1998-09-08
K982288 — RADIAL HEAD IMPLANTAvanta Orthopaedics, Inc.·Product code KWI·1998-09-08
K982401 — PROSTATE BIOPSY NEEDLERemington Medical, Inc.·Product code KNW·1998-09-08
K982439 — PROXIDERM, MODELS TN 460, TN 90 460, BK 460Progressive Surgical Products, Inc.·Product code MKY·1998-09-08
K982445 — MODULAPAtc Medical Technology, Inc.·Product code GCJ·1998-09-08
K982494 — BWM SPINE SYSTEMHowmedica Corp.·Product code KWP·1998-09-08
K982616 — IPS EMPRESS 2Ivoclar North America, Inc.·Product code EIH·1998-09-08
K982665 — JUMBO SILVER-REINFORCED GLASS IONOMERCentrix, Inc.·Product code EMA·1998-09-08
K982705 — MIDAS TOUCH BIPOLAR FORCEPSIti Medical Technologies, Inc.·Product code GEI·1998-09-08
K982865 — ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KITAtrix Laboratories, Inc.·Product code NPK·1998-09-08
K982927 — QUICK TAP SELF DRILLING SCREWKinamed, Inc.·Product code DZL·1998-09-08
K973477 — BIOSENSORS EMBOLECTOMY CATHETERSunscope Intl., Inc.·Product code DXE·1998-09-04
K980630 — FRIALIT-2 CORABASEFriatec AG·Product code DZE·1998-09-04
K980642 — EVITA 4 (8411900)Drager, Inc.·Product code CBK·1998-09-04
K981009 — HEARTPORT ENDOPULMONARY VENT CATHETERHeartport, Inc.·Product code DWF·1998-09-04
K981314 — VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONESun Biomedical Laboratories, Inc.·Product code DJR·1998-09-04
K981999 — ALBATECH PERSONAL MONITORAlbatech, Inc.·Product code GCJ·1998-09-04
K982014 — STOCKERT COMPACT SYSTEMStoeckert Instrumente·Product code DTQ·1998-09-04
K982023 — PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KITInova Diagnostics, Inc.·Product code DAS·1998-09-04
K982025 — HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATORHewlett-Packard Co.·Product code MKJ·1998-09-04
K982088 — AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEMOrtho Kinetics Corp.·Product code DZB·1998-09-04
K982102 — SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CYBaxter Healthcare Corp·Product code MEB·1998-09-04
K982117 — FLUID CONTROLT.A. Coleman Ent.·Product code EIA·1998-09-04
K982339 — FLOW 7000 PERIPHERAL VASCULAR COILUsa Instruments, Inc.·Product code MOS·1998-09-04
K982595 — NIM4Xomed, Inc.·Product code ETN·1998-09-04
K982672 — COLLEAGUE PUMP SYRINGE ADAPTER SETBaxter Healthcare Corp·Product code FPA·1998-09-04
K982841 — MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4Misonix, Inc.·Product code LFL·1998-09-04
K982883 — MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETERMedtronics Interventional Vascular·Product code DQY·1998-09-04
K980883 — N-ASSAY GLU-ULCrestat Diagnostics, Inc.·Product code CFR·1998-09-03
K981639 — SYSTEM U3 FOR CIPROFLOXACINAb Biodisk·Product code JWY·1998-09-03
K981644 — BINDAZYME ANTIGLIADIN IGGThe Binding Site, Ltd.·Product code MST·1998-09-03
K981929 — BINDAZYME ANTIGLIADIN IGG/IGA COMBI KITThe Binding Site, Ltd.·Product code MST·1998-09-03
K981973 — SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEMRam Scientific·Product code JKA·1998-09-03
K981981 — ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19Boston Scientific Corp·Product code GEI·1998-09-03
K981994 — VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETERC.R. Bard, Inc.·Product code MSD·1998-09-03
K982089 — ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPSBoehringer Mannheim Corp.·Product code LFR·1998-09-03
K982491 — SANGUI BIOTECH, INC. CALCITONIN ELISA KITSangui Biotech, Inc.·Product code JKR·1998-09-03
K982709 — MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAYAlexon - Trend, Inc.·Product code MHJ·1998-09-03
K974062 — MEDSCI 3% GLUTARALDEHYDEMedsci, Inc.·Product code MED·1998-09-02
K974770 — ACQPLANPhilips Medical Systems (Cleveland), Inc.·Product code MUJ·1998-09-02
K980686 — AESCULAP HILAN MOTOR SYSTEMAesculap, Inc.·Product code HBB·1998-09-02
K981032 — PIV SYSTEMMedical Solutions, Inc.·Product code LDQ·1998-09-02
K981970 — ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXICavex Holland BV·Product code ELW·1998-09-02
K982002 — ACCU-CHEK COMFORT CURVE TEST STRIPBoehringer Mannheim Corp.·Product code LFR·1998-09-02
K982005 — WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESISBoston Scientific Scimed, Inc.·Product code FGE·1998-09-02
K982044 — NUCAMMA R+Is2 Research, Inc.·Product code KPS·1998-09-02
K982045 — NUCAMMA RXIs2 Research, Inc.·Product code KPS·1998-09-02
K982050 — MODEL MS-2 HANDPIECEParkell, Inc.·Product code EFB·1998-09-02
K982060 — VOLUMAX CT IMAGING SYSTEMElscint, Inc.·Product code JAK·1998-09-02
K982157 — TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICEField Effects·Product code LNH·1998-09-02
K982578 — QUANTI-TEST SYSTEMPanatrex, Inc.·Product code SCL·1998-09-02
K982613 — OMNI PRO LATEX SURGICAL GLOVE, POWDEREDOmnigrace (Thailand) , Ltd.·Product code KGO·1998-09-02
K982645 — PYRAMIDBisco, Inc.·Product code EBF·1998-09-02
K982706 — PHILIPS BV300 SERIES RELEASE 2.1Philips Medical Systems, Inc.·Product code OXO·1998-09-02
K982774 — SOFT (HYDROPHILIC) CONTACT LENSESCl-Tinters·Product code LPL·1998-09-02
K980721 — SULLIVAN AUTOSETResmed, Ltd.·Product code BZD·1998-09-01
K980762 — PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICEPall Corp.·Product code DTM·1998-09-01
K981168 — COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPSAllergan, Inc.·Product code LPN·1998-09-01
K981952 — COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASERInstruments For Medicine and Diagnostics·Product code GEX·1998-09-01
K982193 — ESOPHAGEAL STETHOSCOPEShore Medical, Inc.·Product code BZT·1998-09-01
K982345 — VASCO SCANNING BEAM DIGITAL X-RAY SYSTEMCardiac Mariners, Inc.·Product code JAA·1998-09-01
K982501 — ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44Alko Diagnostic Corp.·Product code JIX·1998-09-01
K982904 — ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENSLes Laboratoires Blanchard·Product code LPL·1998-09-01
K964977 — IVOC- INTEGRATED VOICE OPERATED CONTROL UNIT (IVOC-1)Interactive Living Systems, Inc.·Product code LFF·1998-08-31
K973649 — HEMOSITE TEST SYSTEMGds Technology, LLC·Product code KHG·1998-08-31
K980489 — VAPAMASTA 6Medical Industrial Equipment·Product code CAD·1998-08-31
K981066 — FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPHFukuda Denshi USA, Inc.·Product code LOS·1998-08-31
K981934 — THE BAGNOLI-4 EMG SYSTEMDelsys, Inc.·Product code HCC·1998-08-31
K982066 — MP-3 POWER BASE CHAIRMerits Health Products., Inc.·Product code ITI·1998-08-31
K982068 — HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEMHowmedica Corp.·Product code JDW·1998-08-31
K982141 — ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025Arrow Intl., Inc.·Product code DXE·1998-08-31
K982155 — SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEMInfluence, Inc.·Product code MBI·1998-08-31
K982158 — SCOUTBurke, Inc.·Product code ITI·1998-08-31
K982248 — HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-AHowmedica, Inc.·Product code LPH·1998-08-31
K982347 — DEPUY ACE TIMAX PILON PLATEDepuy Ace Medical Co.·Product code HRS·1998-08-31
K982607 — MANUAL WHEELCHAIRG. Hirsch and Co., Inc.·Product code IOR·1998-08-31
K982677 — UNI/MONOPOLAR HF CABLERichard Wolf Medical Instruments Corp.·Product code GEI·1998-08-31
K982900 — PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREWDepuy, Inc.·Product code MAI·1998-08-31
K981011 — POS-T-VAC (REJOYN VACUUM ERECTION DEVICE)Pos-T-Vac, Inc.·Product code LKY·1998-08-28
K981180 — REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT AND POS-T-VAC B-10 RING KITPos-T-Vac, Inc.·Product code LKY·1998-08-28
K981653 — AMYAbbott Laboratories·Product code JFJ·1998-08-28

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