FDA 510(k) clearances — page 921

176,637 clearances on record, most recent first.

Clearances — page 921

92,001–92,100 of 176,637

K972771 — PHASED ARRAY TRANSDUCER - - PVF -375DTToshiba America Medical Systems, In.C·Product code ITX·1998-02-11
K972856 — ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLSRocket Medical Plc·Product code KNF·1998-02-11
K973827 — KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATIONKimberly-Clark Corp.·Product code KCT·1998-02-11
K974250 — VERSASTAT MULTIPOLAR SCISSORS AND CABLESPilling Weck, Inc.·Product code GEI·1998-02-11
K974661 — 0.2 U BACTERIAL FILTERSims Deltec, Inc.·Product code FPB·1998-02-11
K974832 — POWDERFREE LATEX EXAMINATION GLOVESServicom Services Sdn Bhd·Product code LYY·1998-02-11
K973225 — CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)Getinge/Castle, Inc.·Product code FLE·1998-02-10
K973542 — MASKYPressing DI Monticelli Rag. Stefano·Product code EBI·1998-02-10
K973663 — PALJET-BGolden Gate Bio-Device·Product code DRX·1998-02-10
K973867 — SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEMSchwartz Electro-Optics, Inc.·Product code GEX·1998-02-10
K974222 — CES MASSTRANSIT INFUSION CATHETERCordis Neurovascular, Inc.·Product code KRA·1998-02-10
K974229 — LS-905 FIBERCHOICE ADAPTER SYSTEMLaser Peripherals, LLC·Product code GEX·1998-02-10
K974235 — AMPLAID AM50Amplifon S.P.A.·Product code ETY·1998-02-10
K974237 — GSI 70 AUDIOPATH SCREENERGrason-Stadler, Inc.·Product code EWO·1998-02-10
K974239 — AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEMAktina Medical Physics Corp.·Product code IXI·1998-02-10
K974247 — 40 CC GRANDEBoston Scientific Corp·Product code DSP·1998-02-10
K974287 — FM RECEIVER - AUDITORY TRAINERPhonic Ear, Inc.·Product code EPF·1998-02-10
K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBINGByron Medical·Product code KGZ·1998-02-10
K974323 — LATEX CONDOMS NATURAL COLOUR WITH SILICONE OIL LUBRICANTReddy Medtech Health Products , Ltd.·Product code HIS·1998-02-10
K974347 — BALDUR NON-STERILE COTTON SPONGESBaldur Systems Corp.·Product code EFQ·1998-02-10
K974358 — FRIALIT -2 SCREWFriatec AG·Product code DZE·1998-02-10
K974359 — FRIALIT-2 CYLINDERFriatec AG·Product code DZE·1998-02-10
K974381 — CANDELA GENTLELASE GL DERMATOLOGICAL LASERCandela Corp.·Product code GEX·1998-02-10
K974397 — STERILE SALINE FOR CATHETER CAREBaxter Healthcare Corp·Product code JOL·1998-02-10
K974484 — ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODEXimed/Prosure/Injectx·Product code GEI·1998-02-10
K974494 — RENAMEL FLOWABLE COMPOSITECosmedent, Inc.·Product code EBD·1998-02-10
K974543 — L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGERLuther Medical Products, Inc.·Product code FOZ·1998-02-10
K974622 — DENTAL DMicro Dental Laboratories·Product code EHP·1998-02-10
K974629 — O.B. APPLICATOR AND NON-APPLICATOR TAMPONSPersonal Products Co.·Product code HEB·1998-02-10
K974772 — UFI GEL CVoco GmbH·Product code EBI·1998-02-10
K974811 — ACCURUN(TM) 150 HSV IGG POSITIVE CONTROLBoston Biomedica, Inc.·Product code JJX·1998-02-10
K971471 — ELASTYREN POWDER-FREE SURGICAL GLOVEEci Medical Technologies, Inc.·Product code KGO·1998-02-09
K972478 — PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIESApplied Medical Technologies·Product code KNT·1998-02-09
K973221 — COMPOSITE 168 RESTORATIVE SYSTEMDentsply Intl.·Product code EBF·1998-02-09
K973350 — BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TESTBio-Rad·Product code JLX·1998-02-09
K973692 — UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVEUnited Biotech, Inc.·Product code DCK·1998-02-09
K974212 — AIRIS IIHitachi Medical Systems America, Inc.·Product code LNH·1998-02-09
K974324 — LATEX CONDOMS COLOUR WITH SPERMICIDAL LUBRICANTReddy Medtech Health Products , Ltd.·Product code LTZ·1998-02-09
K974326 — LATEX CONDOMS (NATURAL COLOUR)Reddy Medtech Health Products , Ltd.·Product code LTZ·1998-02-09
K974350 — ALLERGAN IMMUNO CAP M4, M8, K70Pharmacia, Inc.·Product code DHB·1998-02-09
K974432 — ULTRAGUIDE 1000Ultraguide , Ltd.·Product code IYO·1998-02-09
K974463 — IMMUNO CONCEPTS ANCA TEST SYSTEMImmuno Concepts, Inc.·Product code MOB·1998-02-09
K974478 — IMMUNO CONCEPTS ANCA TEST SYSTEMSImmuno Concepts, Inc.·Product code MOB·1998-02-09
K974483 — NTL-FLOWBisco, Inc.·Product code EBF·1998-02-09
K974541 — MODIFIED URETERAL INDWELLING CATHETER/STENTBoston Scientific Corp·Product code FAD·1998-02-09
K974580 — ALLERGEN IMMUNOCAP F256,F245,F207,F202Pharmacia & Upjohn Co.·Product code DHB·1998-02-09
K974783 — ENCORE MARK IV POWDER FREE SURGICAL GLOVESAnsell Perry·Product code KGO·1998-02-09
K974853 — LATEX (POWDER FREE) LOW PROTEINP.T. Healthcare Glovindo·Product code LYY·1998-02-09
K980037 — POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)Sri Johani Sdn. Bhd.·Product code LYY·1998-02-09
K980038 — POWDERFREE GREEN LATEX EXAMINATION GLOVESSri Johani Sdn. Bhd.·Product code LYY·1998-02-09
K980039 — POWDERED GREEN LATEX EXAMINATION GLOVESSri Johani Sdn. Bhd.·Product code LYY·1998-02-09
K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMRadiometer America, Inc.·Product code CHL·1998-02-09
K980150 — POWDER-FREE NITRILE EXAMINATION GLOVESMasju Sdn. Bhd.·Product code LZA·1998-02-09
K980191 — MANAN BILIARY DRAINAGE CATHETERMedical Device Technologies, Inc.·Product code FGE·1998-02-09
K971799 — PRECISION FLOW OSV IIElekta Implants, SA·Product code JXG·1998-02-06
K972326 — PEBA ANCHOR/SUTURE COMBINATIONOrthopaedic Biosystems, Ltd.·Product code MBI·1998-02-06
K972740 — HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)Himex Production Corp.·Product code KFM·1998-02-06
K972906 — MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA)Medtronic Vascular·Product code GZB·1998-02-06
K972959 — AMPLAID MK22Amplifon S.P.A.·Product code GWF·1998-02-06
K973669 — THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)Micro Therapeutics, Inc.·Product code MCW·1998-02-06
K973949 — PERIOPERATIVE DATA MANAGEMENT SYSTEMDraeger Medical, Inc.·Product code BSZ·1998-02-06
K974101 — DATEX-ENGSTROM NETWORKDatex-Engstrom, Inc.·Product code MSX·1998-02-06
K974199 — ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMENT (ACI-TIPI) OPTIONMarquette Medical Systems, Inc.·Product code LOS·1998-02-06
K974205 — KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBONConvatec, A Division of E.R. Squibb & Sons·Product code KMF·1998-02-06
K974209 — SILICONE TISSUE/INFLATABLE TISSUE EXPANDERSpecialty Surgical Products, Inc.·Product code LCJ·1998-02-06
K974301 — CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVERClk Intl., Inc.·Product code ITX·1998-02-06
K974310 — NOMOS SLIT COLLIMATOR (BEAK)Nomos Corp.·Product code IYE·1998-02-06
K974331 — UNI-ROM TOTAL HIP SYSTEM FEMORAL STEMJohnson & Johnson Professionals, Inc.·Product code LPH·1998-02-06
K974448 — CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMCordis Corp.·Product code DYB·1998-02-06
K974496 — A-2000 EEG MONITOR WITH BISAspect Medical Systems, Inc.·Product code OLW·1998-02-06
K974514 — EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATORNeuromotion, Inc.·Product code GZI·1998-02-06
K974520 — SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAMInnovative Technologies (Us), Inc.·Product code MGP·1998-02-06
K974530 — DUFFUSION-WEIGHTED MR IMAGING PACKAGEPhilips Medical Systems (Cleveland), Inc.·Product code LNH·1998-02-06
K974626 — P.T. MACHINEGoodman, Goodman & Goodman·Product code JFB·1998-02-06
K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.·Product code JJQ·1998-02-06
K980211 — MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLESManan Medical Products, Inc.·Product code KNW·1998-02-06
K972990 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEMGE Medical Systems·Product code LNH·1998-02-05
K973235 — DYRACT AP RESTORATIVEDentsply Intl.·Product code EBF·1998-02-05
K973336 — IMEX STETHODOPImex Medical Systems, Inc.·Product code JAF·1998-02-05
K973590 — HEMORRELIEF DEVICEA.Stein - Regulatory Affairs Consulting·Product code LKX·1998-02-05
K973734 — STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATIONWelcon, Inc.·Product code JOL·1998-02-05
K974372 — AIR OXYGE MIXERSk Med·Product code BZR·1998-02-05
K974526 — EASYBLOOD GAS ANALYZERMedica Corp.·Product code CHL·1998-02-05
K974616 — SINGER ACUPUNCTURE NEEDLESLorac, Inc.·Product code MQX·1998-02-05
K974809 — ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROLBoston Biomedica, Inc.·Product code LSR·1998-02-05
K974810 — ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROLBoston Biomedica, Inc.·Product code LSR·1998-02-05
K974873 — VACUETTE (MULTI-USE HOLDER)Greiner Meditech, Inc.·Product code JKA·1998-02-05
K980057 — CARESIDE BUNExigent Diagnostics, Inc.·Product code CDQ·1998-02-05
K980098 — VACUTAINER BRAND PRONTO NEEDLES HOLDERBecton Dickinson Vacutainer Systems·Product code JKA·1998-02-05
K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.·Product code JJQ·1998-02-04
K973996 — CLEARLINE PLUS, DENTAL WATERLINE FILTERScitech Solutions, Inc.·Product code EIA·1998-02-04
K974195 — FLEXIBLE TIP DIGITAL THERMOMETERK-Jump Health Co., Ltd.·Product code FLL·1998-02-04
K974203 — PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEMIntegrated Orbital Implants, Inc.·Product code MQU·1998-02-04
K974213 — AURORA TITANIUM SPINAL ROD SYSTEMUnited States Surgical, A Division of Tyco Healthc·Product code MNH·1998-02-04
K974238 — DENTAL TRAY, STERILE, DISPOSABLETrinity Laboratories, Inc.·Product code EIA·1998-02-04
K974390 — GLUMA ONE BONDHeraeus Kulzer, Inc.·Product code KLE·1998-02-04
K974582 — QUICKSCREEN ONE STEP PCP SCREENING TESTPhamatech·Product code LCM·1998-02-04
K974635 — PARAGON LENS CAREParagon Vision Sciences·Product code LRX·1998-02-04
K974839 — ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KITFirst Medical, Inc.·Product code MMI·1998-02-04
K980013 — AMYLASEAc Biochemicals, Inc.·Product code CIJ·1998-02-04

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