FDA 510(k) clearances — page 934

176,637 clearances on record, most recent first.

Clearances — page 934

93,301–93,400 of 176,637

K973142 — DBEST REAGENT STRIP FOR URINALYSISAmeritek, Inc.·Product code JIL·1997-10-20
K973208 — FIRST SIGNTexas Immunology, Inc.·Product code LCX·1997-10-20
K973292 — I-STAT SYSTEMI-Stat Corp.·Product code CGL·1997-10-20
K973440 — REXAM FRACTURE RESISTANT POUCHRexam Medical Packaging, Inc.·Product code KCT·1997-10-20
K973535 — ACE CARBAMAZEPINE REAGENT/AED CALIBRATORSSchiapparelli Biosystems, Inc.·Product code KLT·1997-10-20
K973650 — TROPONIN (TROP) METHODDade Chemistry Systems, Inc.·Product code MMI·1997-10-20
K973668 — CARDIAC TROPONIN-I (TROP) CALIBRATORDade Intl., Inc.·Product code JIT·1997-10-20
K970864 — ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERSArrow Intl., Inc.·Product code FOZ·1997-10-17
K971233 — SOFT TIP EPIDURAL CATHETER KITB.Braun Medical, Inc.·Product code CAZ·1997-10-17
K972658 — MAGI ACUPUNCTURE NEEDLESDong Bang, U.S.A.·Product code MQX·1997-10-17
K972659 — DONG BANG ACUPUNCTURE NEEDLESDong Bang, U.S.A.·Product code MQX·1997-10-17
K972714 — SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEMSiemens Medical Solutions USA, Inc.·Product code DSI·1997-10-17
K972786 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366Alexander Mfg. Co.·Product code DQA·1997-10-17
K972787 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-PAlexander Mfg. Co.·Product code DRT·1997-10-17
K972789 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016Alexander Mfg. Co.·Product code DRT·1997-10-17
K972818 — D72 DIGITALPhilips Hearing Instruments Co.·Product code ESD·1997-10-17
K972840 — N ANTISERUM TO HUMAN TRANSFERRINBehring Diagnostics, Inc.·Product code DDG·1997-10-17
K973368 — STRAIT'MAP OPTIONGe Medical Systems, Inc.·Product code IZI·1997-10-17
K962829 — HARMAC BALLOON ANGIOGRAPHIC CATHETERHarmac Medical Products, Inc.·Product code DQO·1997-10-16
K963335 — HARMAC BALLOON WEDGE PRESSURE CATHETERHarmac Medical Products, Inc.·Product code DQO·1997-10-16
K964159 — CD SPINAL SYSTEMSofamor Danek USA,Inc.·Product code KWP·1997-10-16
K964880 — VARI-ANGLE HIP SCREW (VHS) SYSTEMWalter Abendschein, M.D.·Product code KTT·1997-10-16
K970499 — BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEMNobel Biocare Uas, Inc.·Product code DZE·1997-10-16
K970741 — POWERHEART AECDCardiac Science, Inc.·Product code MKJ·1997-10-16
K971137 — BARD RAPIDFIRE MULTIPLE BAND LIGATORC.R. Bard, Inc.·Product code MND·1997-10-16
K971576 — REJOYN PENILE SUPPORT SYSTEMAmerican Medtech·Product code LKY·1997-10-16
K971883 — SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEMSynthes (Usa)·Product code KWQ·1997-10-16
K972143 — MOA BONE / M-SPHEREIop, Inc.·Product code HPZ·1997-10-16
K972156 — QUIX RAPID E. COLI O157 STRIP TESTGuardian Scientific, Corp.·Product code GMZ·1997-10-16
K972229 — IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEMHeartware, Inc.·Product code IZI·1997-10-16
K972709 — TBI STANDMick Radio-Nuclear Instruments, Inc.·Product code IYE·1997-10-16
K972792 — DURATION STABILIZED UHMWPE ACETABULAR COMPONENTSHowmedica Corp.·Product code JDI·1997-10-16
K973017 — SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIPSynthes (Usa)·Product code KTT·1997-10-16
K973039 — LEGACY/LEGACY-D TABLEGE Medical Systems·Product code IXR·1997-10-16
K973067 — DRTS REMOTE CONTROL DRAPEMinrad, Inc.·Product code JAA·1997-10-16
K973247 — VINTAGE HALOShofu Dental Corp.·Product code EIH·1997-10-16
K973265 — VERABOND 2VAalba Dent, Inc.·Product code EJH·1997-10-16
K973500 — BARD ENDOSCOPIC OVERTUBE (#000307)C.R. Bard, Inc.·Product code FED·1997-10-16
K973526 — SUNGLASSESPyramid Handbags, Inc.·Product code HQY·1997-10-16
K973530 — INFINTY DISTAL FEMORAL COMPONENTWrightmedicaltechnologyinc·Product code LPH·1997-10-16
K962833 — HARMAC TEMPORARY PACING CATHETER WITH BALLOONHarmac Medical Products, Inc.·Product code LDF·1997-10-15
K972690 — ZIRCONIA CERAMIC FEMORAL HEADZimmer, Inc.·Product code LZO·1997-10-15
K972691 — ABC TOTAL ELBOW PROTHESISBiomet, Inc.·Product code JDB·1997-10-15
K972807 — (LENSES)BENZ HEFILCON A SPHERICAL/TORIC SOFT (HYDROPHILIC) CONTACT LENSES IN CLEAR AND WITH A BLUE OR LIGHT GREEN VISIBIBenz Research and Development Corp.·Product code LPL·1997-10-15
K972826 — ESTEEM 1.5T MRI SYSTEMElscint Mr, Inc.·Product code LNH·1997-10-15
K972879 — ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTIONImatron, Inc.·Product code JAK·1997-10-15
K972973 — PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEMPerception, Inc.·Product code IYO·1997-10-15
K970839 — SERVO VENTILATOR 300ASiemens Elema AB·Product code CBK·1997-10-14
K971501 — SLEEPSCAN AIRFLOW PRESSURE TRANSDUCERBio-Logic Systems Corp.·Product code MNR·1997-10-14
K972686 — VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTERSmv America·Product code KPS·1997-10-14
K972762 — CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRESCardio Metrics, Inc.·Product code DQX·1997-10-14
K972910 — PORS ON LITEDegussa Corp.·Product code EJT·1997-10-14
K973175 — TONGUE KLEANSoftek Ent.·Product code LCN·1997-10-14
K973376 — LORI/LORI, LORI-S (LORI STOCK AID)Lori Medical Laboratories, Inc.·Product code ESD·1997-10-14
K973790 — ABC LINEARITY VERIFIERSSc Calibrators & Controls, LLC·Product code JJY·1997-10-14
K973791 — ABC CALIBRATION VERIFIERSSc Calibrators & Controls, LLC·Product code JJY·1997-10-14
K961008 — AUTOMIX 3+3/AS COMPOUNDER SYSTEMBaxter Healthcare Corp·Product code LHI·1997-10-10
K962774 — OSTEOMED QUICKFIXOsteomed Corp.·Product code DZL·1997-10-10
K963136 — PACER MODEL 100 INFUSION CONTROLLERHealth Watch, Inc.·Product code LDR·1997-10-10
K964056 — RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILERusch Intl.·Product code JOH·1997-10-10
K965112 — MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKSMedline Industries, Inc.·Product code DQO·1997-10-10
K971628 — SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)Somanetics Corp.·Product code DQA·1997-10-10
K971896 — GALILEO HIGH RESOLUTION MICRO COUPLERNetoptix Corp.·Product code HET·1997-10-10
K972495 — ACCUMETER THEOPHYLLINE TESTChemtrak, Inc.·Product code KLS·1997-10-10
K972607 — PLATALLOYAalba Dent, Inc.·Product code EJH·1997-10-10
K972664 — STORZ MILLENNIUM VISCOUS FLUID SYSTEMStorz Instrument Co.·Product code MRH·1997-10-10
K972684 — INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEMInnerdyne, Inc.·Product code DYB·1997-10-10
K972727 — CBALK-1000 BLADEHoward Instruments, Inc.·Product code HNO·1997-10-10
K972796 — SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUMSigma Diagnostics, Inc.·Product code GJS·1997-10-10
K972799 — DRIED GRAM-POSITIVE MIC/COMBO PANELSDade Microscan, Inc.·Product code LTT·1997-10-10
K972823 — MINI-EMBRYON INTRA UTERINE INSEMINATION CATHETERA & A Medical, Inc.·Product code MFD·1997-10-10
K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.·Product code KOE·1997-10-10
K972977 — INSULATOR WIRE GUIDECook Urological, Inc.·Product code KNY·1997-10-10
K973112 — ELECSYS DIGOXINBoehringer Mannheim Corp.·Product code KXT·1997-10-10
K973157 — LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETPointe Scientific, Inc.,·Product code JQB·1997-10-10
K973488 — LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1997-10-10
K973489 — LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISCOxoid , Ltd.·Product code JTN·1997-10-10
K973557 — LUBRIGLIDEQualis, Inc.·Product code KMJ·1997-10-10
K962977 — MRI COMPATIBLE BIOPSY NEEDLESManan Medical Products, Inc.·Product code KNW·1997-10-09
K964434 — SD-970EMS ELECTRICAL MUSCULAR STIMULATORSkylark Device Co., Ltd.·Product code IPF·1997-10-09
K971281 — RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLEMedcomp·Product code DQX·1997-10-09
K971320 — CRE BALLOON DILATATION CATHETERBoston Scientific Corp·Product code KNQ·1997-10-09
K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.·Product code KQJ·1997-10-09
K972130 — DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVRFairmontmedical·Product code IZJ·1997-10-09
K972622 — STRAIGHT-IN BONE SCREW FIXATION SYSTEMInfluence, Inc.·Product code MBI·1997-10-09
K972629 — DEPUY AE TK2 HIP SCREW SYSTEMDepuy, Inc.·Product code KTT·1997-10-09
K972641 — DUAL OFFSET PERFECTA IMC HIP STEMWrightmedicaltechnologyinc·Product code JDI·1997-10-09
K972813 — GAMMA LOCKING NAIL SYSTEMHowmedica Corp.·Product code HSB·1997-10-09
K972876 — GLUCOTREND BASIC SYSTEMBoehringer Mannheim Corp.·Product code LFR·1997-10-09
K973015 — MULTITAK SS SUTURE SYSTEMBonutti Research·Product code MBI·1997-10-09
K973062 — TWIST RECIPROCATING DISPOSABLE PROPHY ANGLEMedidenta Intl., Inc.·Product code EFA·1997-10-09
K973075 — ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ONRoche Diagnostic Systems, Inc.·Product code DKZ·1997-10-09
K973177 — MAGO AUTOMATED EIA PROCESSORDiamedix Corp.·Product code JJF·1997-10-09
K973418 — UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)Assembly Required Dist., Inc.·Product code IOR·1997-10-09
K963913 — MD100 & MM150Konica Medical Corp.·Product code EAM·1997-10-08
K963914 — CM & CM DS-7Konica Medical Corp.·Product code IXA·1997-10-08
K970233 — GELBFISH ENDO-VAC SYSTEMGary A. Gelbfish·Product code MCW·1997-10-08
K971273 — INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EFBio-Tek Instruments, Inc.·Product code DQA·1997-10-08
K971712 — COEUR 130 ML ANGIOGRAPHIC SYRINGECoeur Laboratories, Inc.·Product code DXT·1997-10-08
K971877 — LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATORDideco S.P.A.·Product code DTZ·1997-10-08

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