FDA 510(k) clearances — page 692

176,637 clearances on record, most recent first.

Clearances — page 692

69,101–69,200 of 176,637

K040931 — PATXFER RTBrainlab AG·Product code LLZ·2004-07-22
K040978 — TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGETanita Corp. of America·Product code MNW·2004-07-22
K040991 — AMBU DISPOSABLE PRESSURE MANOMETERAmbu, Inc.·Product code CAP·2004-07-22
K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYDepuy, Inc.·Product code JWH·2004-07-22
K041150 — MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELSDade Behring, Inc.·Product code LRG·2004-07-22
K041151 — KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIESKerberos Proximal Solutions, Inc.·Product code DQY·2004-07-22
K041213 — 3DSCOPEDirex Systems Corp.·Product code OXO·2004-07-22
K041232 — GETTIG UNIVERSAL VIAL ACCESS PINGettig Pharmaceutical Instrument Co.·Product code LHI·2004-07-22
K041345 — PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIESMedix, Inc.·Product code FOZ·2004-07-22
K041439 — SAS INFLUENZA B TESTSa Scientific, Inc.·Product code PSZ·2004-07-22
K041441 — SAS INFLUENZA A TESTSa Scientific, Inc.·Product code PSZ·2004-07-22
K041453 — SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023Smith & Nephew, Inc.·Product code DWQ·2004-07-22
K041544 — COOK SIDEARM CORE TISSUE BIOPSY DEVICEUrological, Inc.·Product code KNW·2004-07-22
K041583 — PEEK CEMENT RESTRICTOR X-BOXInnovasis, Inc.·Product code JDK·2004-07-22
K041646 — THERMOTEK Q5Saat , Ltd.·Product code FLL·2004-07-22
K041671 — IMAGENMDCardiovascular Imaging Technologies, LLC·Product code KPS·2004-07-22
K041701 — AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEMAgfa Corp.·Product code MQB·2004-07-22
K041713 — SUPER REVO HERCULINE SUTURE ANCHORLinvatec Corp.·Product code MBI·2004-07-22
K041716 — PTFE FELTS AND PLEDGETSBoston Scientific Corp·Product code DXZ·2004-07-22
K041719 — ONCENTRA-VISIRNucletron Corp.·Product code MUJ·2004-07-22
K041759 — ACE CONNECT INTERNAL CONNECTIONAce Surgical Supply Co., Inc.·Product code DZE·2004-07-22
K041807 — LUNG CAR 1.1Medicsight·Product code OEB·2004-07-22
K041819 — GOODKNIGHT 425, MODELM-114500-00Mallinckrodt Developpement France·Product code BZD·2004-07-22
K041938 — MAXIMUS OS (OVERDENTURE SYSTEM)BioHorizons Implant Systems, Inc.·Product code DZE·2004-07-22
K041112 — MAGNETOM ESPREE SYSTEMSiemens Medical Solutions USA, Inc.·Product code LNH·2004-07-21
K041286 — DYNACAD V1.0Mri Devices Corp.·Product code LNH·2004-07-21
K041411 — MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-APMicrolife Corp.·Product code DXN·2004-07-21
K041423 — VIABIL BILIARY ENDOPROSTHESISW. L. Gore & Associates, Inc.·Product code FGE·2004-07-21
K041474 — MAXCEMSybron Dental Specialties, Inc.·Product code EMA·2004-07-21
K041568 — EOCDRespironics, Inc.·Product code NFB·2004-07-21
K041596 — ARCHITECT STAT CK-MB IMMUNOASSAYFisher Diagnostics·Product code JHX·2004-07-21
K041741 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIENPhilips Medical Systems, Inc.·Product code MHX·2004-07-21
K040400 — MYO-TRODE SG DISPOSABLE ELECTRODEMyotronics-Noromed, Inc.·Product code NUW·2004-07-20
K040465 — LATIT FLOWAb Ardent·Product code EBF·2004-07-20
K040897 — DOVER ROB-NEL CATHETERTyco Healthcare·Product code KOD·2004-07-20
K041039 — FERTELL MALE FERTILITY TESTGenosis , Ltd.·Product code POV·2004-07-20
K041109 — ZIMMER ANATOMIC II HIP PROSTHESISZimmer, Inc.·Product code LPH·2004-07-20
K041327 — MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIESMed2000 S.R.L.·Product code CAF·2004-07-20
K041336 — PRO WALKER PL-200 POWER WHEELCHAIRPro Walker, Inc.·Product code ITI·2004-07-20
K041376 — C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925AAnalogic Corp.·Product code MWI·2004-07-20
K041417 — DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423Dade Behring, Inc.·Product code NBC·2004-07-20
K041814 — FS SERIES WHEELCHAIRFoshan Dongfang Medical Equipment Manufactory(Ltd)·Product code IOR·2004-07-20
K033897 — MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEMAga-Linde Health Care·Product code ECX·2004-07-19
K040010 — GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMSGenesis Medical Interventional, Inc.·Product code QEW·2004-07-19
K041119 — EXPEDIUM SPINE SYSTEMDepuy Spine, Inc.·Product code KWP·2004-07-19
K041174 — CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196Sweden Diagnostics (Germany) GmbH·Product code MVM·2004-07-19
K041317 — MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMPMedtronic Minimed·Product code LZG·2004-07-19
K041318 — MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMPMedtronic Minimed·Product code LZG·2004-07-19
K041324 — CALMATRIX CALCIUM SULFATE BONE GRAFT BINDERLifecore Biomedical, Inc.·Product code LYC·2004-07-19
K041338 — MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIESMedtronic Vascular·Product code MWS·2004-07-19
K041481 — MODEL BBC-127 BIOPSY BREAST COILMri Devices Corp.·Product code MOS·2004-07-19
K041674 — THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNITPhilips Medical Systems·Product code DQA·2004-07-19
K041794 — C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEMInterpore Cross Intl.·Product code KWQ·2004-07-19
K041816 — RTX3320PSTN WIRELESS TELEHEALTH GATEWAYRtx Healthcare A/S·Product code DRG·2004-07-19
K031395 — MERLIN RESUSCITATORMerlin Medical Limited·Product code BTM·2004-07-16
K040466 — BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITSThe Binding Site·Product code MVM·2004-07-16
K040554 — ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256Manufacturing Technology, Inc.·Product code GWQ·2004-07-16
K040851 — MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEMPorex Surgical, Inc.·Product code HPZ·2004-07-16
K040896 — MODIFICATION TO ENCOMPASSHeartlab, Inc.·Product code LLZ·2004-07-16
K041042 — SPLIT SEPTUM INJECTION SITESFresenius Medical Care North America·Product code FPA·2004-07-16
K041111 — MAGNETOM C! MR SYSTEMSiemens Medical Solutions USA, Inc.·Product code LNH·2004-07-16
K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.·Product code FPK·2004-07-16
K041344 — OPEN BORE SYRINGEIsotis NV·Product code FMF·2004-07-16
K041354 — VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896Sweden Diagnostics (Germany) GmbH·Product code MST·2004-07-16
K041564 — Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01Bioject Medical Technologies, Inc.·Product code LHI·2004-07-16
K041575 — FENZIAN TREATMENT SYSTEMEumedic Limited·Product code GZJ·2004-07-16
K041607 — QUINTON Q-TE; RMSQuinton Cardiology, Inc.·Product code MHX·2004-07-16
K041620 — NEURA WRAP NERVE PROTECTORIntegra Lifesciences Corp.·Product code JXI·2004-07-16
K041624 — PTCA STEERABLE HYDROPHILIC GUIDEWIRELake Region Mfg., Inc.·Product code DQX·2004-07-16
K041649 — SAPPHIRE NXT DETACHABLE COIL SYSTEMMicro Therapeutics, Inc.·Product code HCG·2004-07-16
K041702 — EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)Ibt SA·Product code KXK·2004-07-16
K041793 — OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524Olympus America, Inc.·Product code JMO·2004-07-16
K040649 — KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVETyco Healthcare·Product code JOW·2004-07-15
K041084 — CLIP-ON SPACER 20%; 40%; 50%Serono, Inc.·Product code FMF·2004-07-15
K041148 — POCONE INFRARED SPECTROPHOTOMETEROtsuka Pharmaceutical Co., Ltd.·Product code MSQ·2004-07-15
K041225 — SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWEREDGrand Work Plastic Products Co., Ltd.·Product code LYZ·2004-07-15
K041362 — RESMED HOSPITAL FULL FACE MASKResmed, Ltd.·Product code BZD·2004-07-15
K041473 — VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCMVortran Medical Technology 1, Inc.·Product code BTL·2004-07-15
K041745 — VINYL EXAMINATION GLOVES, POWDER FREE, GREEN COLORArista Latindo Industrial Ltd. P.T·Product code LYZ·2004-07-15
K041773 — OXYGEN MEDICELS, CITICELSCity Technology Limited·Product code CCL·2004-07-15
K041789 — NONINVASIVE BLOOD PRESSURE MONITOR, MODELS MD-880B AND MD-900TMeditec Co., Ltd.·Product code DXN·2004-07-15
K040678 — EUSURE BLOOD GLUCOSE MONITORING SYSTEMEumed Biotechnology Co., Ltd.·Product code NBW·2004-07-14
K040756 — THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXXImplex Corp.·Product code FTM·2004-07-14
K040980 — ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860TWrightmedicaltechnologyinc·Product code MQV·2004-07-14
K041014 — TSH-CTK-3 IRMADiaSorin, Inc.·Product code JLW·2004-07-14
K041753 — AESKULISA ENA 6 SAesku Diagnostics·Product code LLL·2004-07-14
K031431 — BAWMED RESCUE MASKBawmed UK·Product code CBP·2004-07-13
K033105 — CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KITTrinity Biotech USA·Product code MXJ·2004-07-13
K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KITTrinity Biotech USA·Product code MYF·2004-07-13
K040231 — INTELIPORT OCCLUDING DEVICEAlcon, Inc.·Product code LZU·2004-07-13
K040382 — CRANEX BASEX D OR CRANEX EXCEL DSoredex Palodex Group OY·Product code EHD·2004-07-13
K040782 — N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XXImage Analysis, Inc.·Product code JAK·2004-07-13
K041221 — ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASYAccu-Stat Diagnostics, Inc.·Product code LDJ·2004-07-13
K041348 — PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRASmiths Medical·Product code JOH·2004-07-13
K041737 — 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)Totoku Electric Co., Ltd.·Product code LLZ·2004-07-13
K041761 — RAPIDIACOLONInfinitt Co., Ltd.·Product code LLZ·2004-07-13
K041763 — SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIESShimadzu Corp.·Product code IZL·2004-07-13
K033448 — ELECTRO-OPTICAL AIR STERILIZER WITH IONIZERJohn Mfg., Ltd.·Product code FRA·2004-07-12
K033739 — PHYSICIAN INDUSTRIES' DURAMETER SYRINGEPhysician Industries, Inc.·Product code FMF·2004-07-12
K033858 — TEMPORARY BIPOLAR MYOCARDIAL PACING WIREEuropean Custom Manufacturing BV·Product code LDF·2004-07-12

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