FDA 510(k) clearances — page 691

176,637 clearances on record, most recent first.

Clearances — page 691

69,001–69,100 of 176,637

K041806 — PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOPDepuy Mitek, A Johnson & Johnson Company·Product code GAM·2004-08-03
K041970 — BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/MLBiotop Technology Co., Ltd.·Product code MEG·2004-08-03
K041996 — NIGHTFORMPlastic Surgery Solutions, LLC·Product code FRP·2004-08-03
K033222 — OLYMPUS STERILIZATION TRAYSOlympus Winter & Ibe GmbH·Product code KCT·2004-08-02
K041168 — ALLOMATRIX PUTTYWrightmedicaltechnologyinc·Product code MQV·2004-08-02
K041173 — CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996Sweden Diagnostics (Germany) GmbH·Product code MVM·2004-08-02
K041357 — VARELISA GLIADIN IGG ANTIBODIESSweden Diagnostics (Germany) GmbH·Product code MST·2004-08-02
K041378 — BIO 60Kodent, Inc.·Product code EJT·2004-08-02
K041485 — MARPAC MESSENGER MODEL #501Marpac, Inc.·Product code JOH·2004-08-02
K032239 — THERA-CREAM, MODEL TCT004Prizm Medical, Inc.·Product code GYB·2004-07-30
K033655 — SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEARSoflex Contact Lens Industries , Ltd.·Product code LPL·2004-07-30
K040686 — M'ATH STDIntelligence IN Medical Technologies·Product code LLZ·2004-07-30
K041157 — MODIFICATION TO SMALL BONE FIXATION SYSTEMHand Innovations, Inc.·Product code HTY·2004-07-30
K041352 — COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEMBiomet, Inc.·Product code KRO·2004-07-30
K041355 — HUMERAL STAPLESmith & Nephew, Inc.·Product code HTY·2004-07-30
K041469 — ANTERIOR COMPACT SYSTEMX-Spine Systems·Product code KWQ·2004-07-30
K041484 — UNDECIDEDSiemens Medical Solutions USA, Inc.·Product code LLZ·2004-07-30
K041559 — 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55Spire Biomedical, Inc.·Product code MSD·2004-07-30
K041700 — CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEARCantor & Nissel , Ltd.·Product code LPL·2004-07-30
K041707 — CERCON CERAM EXPRESS CERAMIC SYSTEMDentsply Intl.·Product code EIH·2004-07-30
K041828 — APEX MEDICAL CPAP MODEL 9S-003Apex Medical Corp.·Product code BZD·2004-07-30
K041916 — ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEMAloka Co. Ltd USA·Product code IYN·2004-07-30
K041949 — ALLURA XPER FD10Philips Medical Systems North America Co.·Product code IZI·2004-07-30
K031397 — MERLIN E-MASKMerlin Medical Limited·Product code CBP·2004-07-29
K031858 — NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODESRichard Wolf Medical Instruments Corp.·Product code GWG·2004-07-29
K033614 — MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215Northgate Technologies, Inc.·Product code HIF·2004-07-29
K040992 — 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706Medcomp·Product code MSD·2004-07-29
K041044 — CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SETCook, Inc.·Product code JOH·2004-07-29
K041128 — SUTURE ARROWLinvatec Corp.·Product code MAI·2004-07-29
K041223 — MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407EMaquet Critical Care AB·Product code CBK·2004-07-29
K041368 — DENTIUM CO., LTD. IMPLANTIUMDentium Co., Ltd.·Product code DZE·2004-07-29
K041644 — FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)Elekon Industries U.S.A., Inc.·Product code DQA·2004-07-29
K041664 — PORTABLE OXYGEN GENERATION SYSTEM: POGS 33COn Site Gas Systems, Inc.·Product code CAW·2004-07-29
K041815 — LNCS OXIMETRY SENSORSMasimo Corp.·Product code DQA·2004-07-29
K041955 — GEMINI PET/CT IMAGING SYSTEMPhilips Medical Systems (Cleveland), Inc.·Product code KPS·2004-07-29
DEN040008 — CEDIA SIROLIMUS ASSAYMicrogenics Corp.·Product code NRP·2004-07-28
K033313 — QUATRO M FEMORAL COMPONENTWhiteside Biomechanics, Inc.·Product code LWJ·2004-07-28
K033463 — EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAEEdwards Lifesciences, LLC·Product code DWF·2004-07-28
K033930 — KAPP CUSTOM ULNAR HEAD WRIST IMPLANTKapp Surgical Instrument, Inc.·Product code KXE·2004-07-28
K040031 — CERAGEM-C THERMAL ACUPRESSURE MASSAGERCeragem Co., Ltd.·Product code JFB·2004-07-28
K040417 — PILLAR PALATAL IMPLANT SYSTEMRestore Medical, Inc.·Product code LRK·2004-07-28
K040682 — SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREEGrand Work Plastic Products Co., Ltd.·Product code LYZ·2004-07-28
K041105 — MACROPORE HYDROSORB SPINE SYSTEMMacropore Biosurgery, Inc.·Product code KWQ·2004-07-28
K041233 — ARTHROJET XTHydrocision, Inc.·Product code HRX·2004-07-28
K041274 — RESORBABLE INTERFERENCE SCREWArthrotek, Inc.·Product code HWC·2004-07-28
K041340 — GUIDANT MICROWAVE ABLATION SYSTEMGuidant Corporation, Cardiac Surgery·Product code NEY·2004-07-28
K041399 — HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICESmiths Medical Asd, Inc.·Product code FMI·2004-07-28
K041410 — PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118Icu Medical, Inc.·Product code FPA·2004-07-28
K041772 — DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIESDatex-Ohmeda·Product code MHX·2004-07-28
K041922 — GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTORGeneral Electric Co.·Product code IZL·2004-07-28
K033592 — REPROCESSED SURGICAL SCISSORS AND GRASPERSClearmedical, Inc.·Product code GEI·2004-07-27
K040107 — CYTO-CHEX BCTStreck Laboratories, Inc.·Product code JKA·2004-07-27
K040560 — ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGAb Biodisk·Product code NGZ·2004-07-27
K041000 — DUREPAIR DURA REGENERATION MATRIXMedtronic Neurosurgery·Product code GXQ·2004-07-27
K041103 — ACNELIFTInner Act, LLC·Product code GEX·2004-07-27
K041159 — JMS ABSORBABLE ANCHOR AND APPLICATORJms, Inc.·Product code GDW·2004-07-27
K041162 — ORTHO-CMSMedis Medical Imaging Systems BV·Product code LLZ·2004-07-27
K041326 — MEDCOMMONS OPEN RADIOLOGY GATEWAYMedcommons, Inc.·Product code LLZ·2004-07-27
K041328 — SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTORSmith & Nephew, Inc.·Product code GEI·2004-07-27
K041363 — AOC BONE WAXCeremed , Inc.·Product code MTJ·2004-07-27
K041534 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANELTrek Diagnostic Systems, Ltd.·Product code JWY·2004-07-27
K041599 — COBRA ADHERE SURGICAL SYSTEMEstech, Inc.·Product code GEI·2004-07-27
K041600 — QWIKCHECK-BEADSMedical Electronics Systems , Ltd.·Product code NRF·2004-07-27
K041682 — CAAS MRVPie Medical Imaging BV·Product code LLZ·2004-07-27
K041812 — MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC)Roche Diagnostics Corp.·Product code JJY·2004-07-27
K041870 — N APOLIPOPROTEIN STANDARD SERUMDade Behring, Inc.·Product code JIX·2004-07-27
K030290 — PERIOLASE ND:YAG DENTAL LASER SYSTEMMillennium Dental Technologies, Inc.·Product code GEX·2004-07-26
K041403 — ECLIPSE WITH AAAVarian Medical Systems·Product code MUJ·2004-07-26
K041420 — ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KITAngioDynamics, Inc.·Product code LJS·2004-07-26
K041602 — PANORAMA 1.0TPhilips Medical Systems North America, Inc.·Product code LNH·2004-07-26
K041921 — GE SIGNA PROFILE 6 INCH GP COILGe Medical Systems, LLC·Product code MOS·2004-07-26
K031088 — TRIMED PLAN, VERSION 2.2Trimed Systems, Inc.·Product code MUJ·2004-07-23
K031996 — EXTENTRAC ELITEAdvanced Back Technologies·Product code ITH·2004-07-23
K040019 — SILVERSEALNoble Fiber Technologies·Product code MGQ·2004-07-23
K040483 — EQUESTRA FLUID DELIVERY SYSTEMMedtronic Sofamor Danek, Inc.·Product code HRX·2004-07-23
K040754 — AMERICAN BANTEX MS 4 MINI SCOOTERAmerican Bantex Corp.·Product code INI·2004-07-23
K040844 — LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEMLife Spine, LLC·Product code KWQ·2004-07-23
K040913 — NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)Bausch & Lomb·Product code MXK·2004-07-23
K040979 — ELEKTA MICRODRIVE, MODEL 916716Elekta Instrument AB·Product code HAW·2004-07-23
K041070 — STRAUMANN TEMPORARY COPINGThe Straumann Co.·Product code NHA·2004-07-23
K041138 — LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORSCooperVision, Inc.·Product code LPL·2004-07-23
K041167 — PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEMPioneer Surgical Technology·Product code NKB·2004-07-23
K041312 — NOBELRONDO DENTAL CERAMIC-ALUMINANobel Biocare Uas, Inc.·Product code EIH·2004-07-23
K041465 — SINON SN-L402 LIGHTWEIGHT WHEELCHAIRSinon Corporation·Product code IOR·2004-07-23
K041523 — XPS 3000 SYSTEMMedtronic Xomed, Inc.·Product code ERL·2004-07-23
K041665 — L1-PRO SYSTEMPelikan Technologies, Inc.·Product code FMK·2004-07-23
K041675 — PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMSPie Medical·Product code IYN·2004-07-23
K041678 — KARMA POWER WHEELCHAIR, MODEL KP-25Karma Medical Products Co., Ltd.·Product code ITI·2004-07-23
K041695 — LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATEUsa Instruments, Inc.·Product code LNH·2004-07-23
K041726 — HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EXAsahi Medical Co., Ltd.·Product code KDI·2004-07-23
K041727 — MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456Boston Scientific Scimed, Inc.·Product code OBJ·2004-07-23
K041750 — PTS PANELS CHOL+GLU TEST PANELPolymer Technology Systems, Inc.·Product code NBW·2004-07-23
K041790 — DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWAREDatex-Ohmeda·Product code MHX·2004-07-23
K041813 — GE LOGIQ 7 ULTRASOUND BT04Ge Medical Systems Ultrasound and Primary Care Dia·Product code IYN·2004-07-23
K041842 — NORIAN SRS FAST SET PUTTYSynthes (Usa)·Product code MQV·2004-07-23
K041907 — TRIO MONITORDatascope Corp.·Product code MWI·2004-07-23
K041942 — M2376A DEVICELINK SYSTEMPhillips Medical Systems·Product code MWI·2004-07-23
K040565 — PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLEPhysician Industries, Inc.·Product code GXD·2004-07-22
K040766 — OPTISOURCE, MODEL 1032PInternational Brachytherapy S.A.·Product code KXK·2004-07-22
K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbH·Product code JLS·2004-07-22

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