FDA 510(k) clearances — page 1063

176,637 clearances on record, most recent first.

Clearances — page 1063

106,201–106,300 of 176,637

K943566 — ULTIMAX POWDER FREE SURGICAL GLOVES (UNBEADED)Wembley Rubber Products (M) Sdn Bhd·Product code KGO·1995-02-03
K943868 — SCIPOTEXWembley Rubber Products (M) Sdn Bhd·Product code LYY·1995-02-03
K943894 — SYSMEX K-4500Sysmex Corp.·Product code GKZ·1995-02-03
K943895 — VISION SYSTEM COLONSCOPEVision-Sciences, Inc.·Product code FDF·1995-02-03
K944212 — RADIAS RED CELL FOLATE IMMUNOASAYBio-Rad·Product code CGN·1995-02-03
K944227 — ELECTRA 1400C AUTOMATIC COAGULATION ANALYZERMedical Laboratory Automation Systems, Inc.·Product code GKP·1995-02-03
K944344 — LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETERLung Technologies, Inc.·Product code BWF·1995-02-03
K944732 — DEXTER ISOKINETICCedaron Medical, Inc.·Product code IKK·1995-02-03
K944998 — CALIBRATION GASSunox, Inc.·Product code BXK·1995-02-03
K945164 — MULTIPLEProtection Gloves Sdn. Bhd.·Product code LYY·1995-02-03
K945236 — AIMS CANNULATED ACL SCREW (7MM DIAMETER)Smith and Nephew Donjoy, Inc.·Product code HWC·1995-02-03
K945461 — PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)Medtronics Interventional Vascular·Product code DTL·1995-02-03
K945463 — PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEMDraeger Medical, Inc.·Product code BSZ·1995-02-03
K945572 — CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352Johnson & Johnson Professionals, Inc.·Product code GWG·1995-02-03
K945705 — 5F ENVOY(TM) GUIDING CATHETERCordis Neurovascular, Inc.·Product code DQY·1995-02-03
K945725 — PHENYTION EIA TESTDiagnostic Reagents, Inc.·Product code DIP·1995-02-03
K946058 — 60 FUNDUS CAMERA CF-60UVCanon USA, Inc.·Product code HKI·1995-02-03
K946143 — CHEMSPEX(TM) AMMONIA CONTROLClinical Controls, Inc.·Product code JJX·1995-02-03
K950030 — HELIODENT MDPelton & Crane Co.·Product code EAP·1995-02-03
K950286 — SYMBIOSIS BIPOLAR SCISSORSSymbiosis Corp.·Product code GCJ·1995-02-03
K941941 — BONE MULCH SCREWBiomet, Inc.·Product code HWC·1995-02-02
K942669 — SMT-50CX/HShimadzu Medical Systems·Product code LNH·1995-02-02
K943393 — CIVCO PROBE BOOT/CORD COVERCIVCO Medical Instruments Co., Inc.·Product code KKX·1995-02-02
K944068 — RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)Lifecore Biomedical, Inc.·Product code DZE·1995-02-02
K944670 — JARIT RECOMMENDED SINUS INSTRUMENTSJ. Jamner Surgical Instruments, Inc.·Product code EOB·1995-02-02
K945032 — VOYAGER 522Madsen Electronics, Inc.·Product code EWO·1995-02-02
K945366 — PARAPOST CEMENTColtene/Whaledent, Inc.·Product code EMA·1995-02-02
K945569 — GCII AGAR WITH ISOVITALX(R) ENRICHMENTBecton Dickinson Microbiology Systems·Product code JSO·1995-02-02
K945711 — EXCEL-P FORMULA AUTO-CURE DENTURE BASESt. George Technology, Inc.·Product code EBI·1995-02-02
K946025 — 3M X-LARGE SHEET #7979/ #7979NS3M Healthcare·Product code KKX·1995-02-02
K950203 — PROTEMP(R) GARANTEspe GmbH & Co. Kg.·Product code EBG·1995-02-02
K930510 — RADIUS ENTERAL FEEDING TUBERadius Intl., Inc.·Product code BSS·1995-02-01
K931381 — AME UNIVERSAL FIXATION SYSTEMAmerican Medical Electronics, Inc.·Product code KWP·1995-02-01
K931996 — MODEL PDEXA BONE DENSITOMETERNorland Corp.·Product code KGI·1995-02-01
K935255 — ELDOR NEEDLECsen , Ltd.·Product code BSP·1995-02-01
K940555 — SANDOZ NUTRITION COMPAT ENTERAL FEED PUMP W/HYDRATIONSandoz Nutrition·Product code LZH·1995-02-01
K940859 — PACSPRO IAdvanced Video Products, Inc.·Product code LMD·1995-02-01
K941769 — KNEE PROTHESISJoint Medical Products Corp.·Product code JWH·1995-02-01
K942019 — MODEL FP-100International Medical Designs, Inc.·Product code JAA·1995-02-01
K942117 — STA AUTOMATED MULTI-PARAMETRIC ANALYZERAmerican Bioproducts Co.·Product code GKP·1995-02-01
K942848 — STRATO MEDICAL LIFEPORT LPS 7515Strato Medical Corp.·Product code LJT·1995-02-01
K943113 — SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEMAloka Co., Ltd.·Product code IYO·1995-02-01
K943426 — ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPESchoelly Technologies, Inc.·Product code HRX·1995-02-01
K943464 — PHILIPS IMPROVED CHECK RADIOGRAPH OPTIONPhilips Medical Systems North America, Inc.·Product code IYE·1995-02-01
K943492 — ARTHREX STAPLESArthrex, Inc.·Product code JDR·1995-02-01
K944812 — CLINICAL BLOOD GAS MIXTURELaboratory & Specialty Gases, Inc.·Product code BXK·1995-02-01
K944831 — INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENERInnovasive Devices, Inc.·Product code MBI·1995-02-01
K944946 — CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMERU.S. Medical Products, Inc.·Product code HWE·1995-02-01
K945027 — TROCHANTER MESHAcu Med, Inc.·Product code EZX·1995-02-01
K945233 — PEDIATRIC OSTEOTOMY SYSTEMHowmedica Corp.·Product code KTT·1995-02-01
K945245 — BLOOD KIT, SEXUAL ASSAULT KITLynn Peavey Co.·Product code JKA·1995-02-01
K945317 — NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIESAmerican Hydro-Surgical Instruments, Inc.·Product code GEI·1995-02-01
K945464 — FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULEFukuda Denshi USA, Inc.·Product code DQA·1995-02-01
K945491 — SERIM(TM) BICARB PH REAGENT STRIPSSerim Research Corp.·Product code MNV·1995-02-01
K945528 — SUNGLASSES AND SPORT SUNGLASSESLily & Assoicates, Inc.·Product code HQY·1995-02-01
K945635 — TRANS X-1000Canon USA, Inc.·Product code KPX·1995-02-01
K945921 — ECHO STAR NEEDLE SETIdeamatrix·Product code FCG·1995-02-01
K946079 — CAD ON WHEELSRehab 'N Motion Technologies·Product code IOR·1995-02-01
K946110 — REGAIN STAND-UP WHEELCHAIRRegain, Inc.·Product code IPL·1995-02-01
K950170 — CONMED SOFT-TIP SUCTION/IRRIGATION CANNULAEConmedcorp·Product code GCJ·1995-02-01
K950231 — LAPAROSCOPE AND ACCESSORIES FOR GENERAL SURGERYOlympus America, Inc.·Product code GCJ·1995-02-01
K950249 — VASOTRAC BLOOD PRESSURE MONITOR, MODEL - APM 205Medwave, Inc.·Product code DXN·1995-02-01
K950278 — MINI LAPAROSCOPY FOR GENERAL SURGERYOlympus America, Inc.·Product code GCJ·1995-02-01
K925750 — RELAXOMATRelaxomat, Inc.·Product code HCC·1995-01-31
K934478 — ALPHA STEREOInstrumentarium Corp.·Product code IZH·1995-01-31
K935571 — DURALASTIC SHEETINGApplied Biomaterial Technologies·Product code MIB·1995-01-31
K940635 — SAFE-1(TM) SYRINGESafety 1st Medical, Inc.·Product code FMF·1995-01-31
K941190 — CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SETIcu Medical, Inc.·Product code FPA·1995-01-31
K941317 — DRIED GRAM NEGATIVE/CEFMETAZOLEBaxter Diagnostics, Inc.·Product code JWY·1995-01-31
K942921 — NEUROLINK EEG/EP/EMG SURFACE ELECTRODESNeuro Supplies, Inc.·Product code GXY·1995-01-31
K943851 — ALL SILICONE INTERMITTENT CATHETERRochester Medical Corp.·Product code GBM·1995-01-31
K944397 — BNOS MICROVENT, MODEL AC AND MODEL AORacal Health & Safety, Inc.·Product code BTL·1995-01-31
K944680 — SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICEResearched, Novel Medical Devices (Rn/Md)·Product code FMI·1995-01-31
K945382 — TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETERExpertech Assoc., Inc.·Product code HLQ·1995-01-31
K945385 — VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300Pace Tech, Inc.·Product code MHX·1995-01-31
K945552 — DURALASTIC SHEETINGApplied Biomaterial Technologies·Product code MIB·1995-01-31
K945697 — SK S-RAY GRIDSSeibu Techno Coproration·Product code IXJ·1995-01-31
K945995 — BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTSXimed/Prosure/Injectx·Product code GEI·1995-01-31
K946004 — FI, GORDY TOY, WELLJOY AND OTHERSFundamental Industrial Co., Ltd.·Product code HQY·1995-01-31
K946091 — AVON SUNNY DAYS SUNGLASSESSiegel,Mandell & Davidson,P.C.·Product code HQY·1995-01-31
K946092 — AVON SUNNY DAYS SUNGLASSESSiegel,Mandell & Davidson,P.C.·Product code HQY·1995-01-31
K950267 — URETHRAL SUTURE GUIDEApplied Medical Resources·Product code KOA·1995-01-31
K931122 — OVAMED HSG CATHETEROvamed Corp.·Product code LKF·1995-01-30
K933785 — NEXT GENERATION KNEE SYSTEMZimmer, Inc.·Product code JWH·1995-01-30
K935065 — OGDEN ANCHOR ADDITIONAL APPLICATIONSAmerican Medical Electronics, Inc.·Product code JDR·1995-01-30
K940045 — CONDOMAnsell, Inc.·Product code HIS·1995-01-30
K940046 — NON-LUBRICATED CONDOMAnsell, Inc.·Product code HIS·1995-01-30
K940582 — MASSAGING HELMET C.F. HANSEN DESIGNPhilco Ushuaia·Product code IRO·1995-01-30
K940813 — OSTEONICS(R) SERIES 7000 TOTAL KNEEOsteonics Corp.·Product code JWH·1995-01-30
K941112 — SINGLE HANDED BREAST PUMPMacneil Baby Care , Ltd.·Product code HGX·1995-01-30
K941803 — PRISM MEDICAL CUSTOM DIALYSIS KITMedical Device Support Services·Product code KOC·1995-01-30
K942147 — PACIFIC COMMUNICATIONS MODEL 1100Accucore, Inc.·Product code DSI·1995-01-30
K943248 — VISUALINE II MORPHINE/OPIATES/HEROINSun Biomedical Laboratories, Inc.·Product code DJG·1995-01-30
K943493 — DISCRETE PHOTOMETRIC CHEMISTRY ANALYZERHamilton Co.·Product code JJE·1995-01-30
K943653 — MAMMOCORE BIOPSY TRAYManan Medical Products, Inc.·Product code FRG·1995-01-30
K944971 — INCARE HOT/ICE COLD THERAPY COOLERHollister, Inc.·Product code ILO·1995-01-30
K945277 — HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATORHewlett-Packard Co.·Product code DXJ·1995-01-30
K945375 — ADVANTX LCAGE Medical Systems·Product code IZI·1995-01-30
K945388 — DFS-700Shimadzu Corp.·Product code LLZ·1995-01-30
K945459 — DLXGeneral Electric Co.·Product code IZI·1995-01-30

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