FDA 510(k) clearances — page 1072

176,637 clearances on record, most recent first.

Clearances — page 1072

107,101–107,200 of 176,637

K942704 — CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTERCard Guard Scientific Survival , Ltd.·Product code DXH·1994-12-05
K942823 — MAHE INSTRUMENTSMahe Intl., Inc.·Product code DWG·1994-12-05
K942945 — CASSETTE SYSTEM FOR STORZSurgin Surgical Instrumentation, Inc.·Product code HQC·1994-12-05
K943126 — ELECTROFLEXMedical Devices, Inc.·Product code GXY·1994-12-05
K943216 — SURGIDEKSutures , Ltd.·Product code GAR·1994-12-05
K943217 — PLAIN CATGUTSutures , Ltd.·Product code GAL·1994-12-05
K943218 — CHROMIC CATGUTSutures , Ltd.·Product code GAL·1994-12-05
K943220 — SUTULENESutures , Ltd.·Product code GAT·1994-12-05
K943221 — SURGIBONDSutures , Ltd.·Product code GAT·1994-12-05
K943222 — SURGIDEK SSutures , Ltd.·Product code GAR·1994-12-05
K943223 — SURGIDEK BSutures , Ltd.·Product code GAR·1994-12-05
K943270 — SURFACE TEMPERATURE PROBESCoast Medical, Inc.·Product code FLL·1994-12-05
K943527 — MEGABEAM LATERAL FIRECeram Optec, Inc.·Product code GEX·1994-12-05
K943627 — SURGISILKSutures , Ltd.·Product code GAP·1994-12-05
K944119 — SURE-FLO IRRIGATION Y TUBING SETO.R. Resources, Inc.·Product code JCX·1994-12-05
K944252 — BIOPSY DEVICE ACCESSORYBiopsys Medical, Inc.·Product code FCK·1994-12-05
K944356 — KIS-II IMPLANT SYSTEM/DRILLSImplant Center of the Palm Beaches·Product code DZE·1994-12-05
K944363 — MODEL PBD ESU PENCILCoral Medical, Inc.·Product code GEI·1994-12-05
K944941 — PISTON SYRINGEMartell Medical Products, Inc.·Product code CBT·1994-12-05
K945006 — COLLEGIATE COLORSTrey Optics·Product code HQY·1994-12-05
K945332 — ROSEBUD DISSECTORLorrex Health Products·Product code GDY·1994-12-05
K945334 — CHERRY PIT DISSECTORLorrex Health Products·Product code GDY·1994-12-05
K945336 — PEANUT DISSECTORLorrex Health Products·Product code GDY·1994-12-05
K945474 — SCANLAN(R) THORACOSCOPIC SCISSORS, CLAMP, FORCEPS, NEEDLE HOLDERScanlan Intl., Inc.·Product code GCJ·1994-12-05
K931445 — KTP/532, KTP/YAG AND KTP/YAG XPLaser Surgical Systems·Product code GEX·1994-12-02
K934340 — BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTSBiosite Incorporated·Product code LFI·1994-12-02
K935169 — APTT-ESHelena Laboratories·Product code GFO·1994-12-02
K935371 — R2 PADS, R2 CATH PADS, R2 PACE PADS, R2 DISPERSIVE PADR2 Medical Systems·Product code DRX·1994-12-02
K941748 — STERI-VAC GAS STERILIZER MODEL 8XL3M Health Care, Ltd.·Product code FLF·1994-12-02
K942179 — PRO-TEC DISPOSABLE SHARPS CONTAINERSPro-Tec Containers, Inc.·Product code FMI·1994-12-02
K942847 — COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATORRoche Diagnostic Systems, Inc.·Product code LAR·1994-12-02
K942873 — MODEL #700TO3500 NECK/ABDOMINAL COILMedic, Inc.·Product code LNH·1994-12-02
K942875 — MODEL #900TO3500 HEAD/NECK COILMedic, Inc.·Product code LNH·1994-12-02
K942999 — BILIRUBIN(TOTAL) QVETPrisma Systems·Product code CIG·1994-12-02
K943002 — URIC ACID QVETPrisma Systems·Product code KNK·1994-12-02
K943029 — IRON QVETPrisma Systems·Product code JIY·1994-12-02
K943291 — ANTI DS-DNASigma Diagnostics, Inc.·Product code LLL·1994-12-02
K943510 — DRIED GRAM-POSITIVE MIC/COMBO PANELSBaxter Diagnostics, Inc.·Product code JWY·1994-12-02
K943543 — MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMSMedical Options, Inc.·Product code GEX·1994-12-02
K943892 — POINT OF USE SHARPS A GATORDevon Industries, Inc.·Product code FMI·1994-12-02
K944074 — CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYSTBeckman Instruments, Inc.·Product code DJR·1994-12-02
K944114 — PHLEBOTOMY UNIT SHARPS A GATORDevon Industries, Inc.·Product code FMI·1994-12-02
K944231 — ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THCRoche Diagnostic Systems, Inc.·Product code DIO·1994-12-02
K944303 — COOK UROLOGICAL LAPAROSCOPIC TROCAR CLEANERCook Urological, Inc.·Product code GCJ·1994-12-02
K944452 — QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)Beckman Instruments, Inc.·Product code JJY·1994-12-02
K944486 — LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - EInternational Enzymes, Inc.·Product code JJY·1994-12-02
K944513 — LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-EInternational Enzymes, Inc.·Product code JJY·1994-12-02
K944531 — PRIMA, INC. CORRUGATED TUBINGPrima, Inc.·Product code BZO·1994-12-02
K944532 — PRIMA, INC. VENTILATOR HOSESPrima, Inc.·Product code BZA·1994-12-02
K944581 — CUTINOVA THIN WOUND DRESSINGBeiersdorf, Inc.·Product code KMF·1994-12-02
K944702 — PROCERA ALL-CERAMIC PORCELAINNobelpharma USA, Inc.·Product code EIH·1994-12-02
K944953 — OREX MEDICAL BEDDINGThantex Specialties, Inc.·Product code KME·1994-12-02
K944981 — 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM3M Company·Product code EBG·1994-12-02
K945197 — THE SHARPS COLLECTION AND DISPOSAL SYSTEMDevon Industries, Inc.·Product code MMK·1994-12-02
K945288 — INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICEHelix Medical, Inc.·Product code EWL·1994-12-02
K945368 — PHOSPHORUS TEST (PHOS)Emd Chemicals, Inc.·Product code CEO·1994-12-02
K915750 — DISPOSABLE BACTERIAL BREATHNG FILTERHospitak, Inc.·Product code CAH·1994-11-30
K924502 — REUSABLE MENSTRUAL PADKeema and Co.·Product code HHD·1994-11-30
K930771 — PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMOrthomet, Inc.·Product code JDI·1994-11-30
K931065 — LAPAROVIEWNorthgate Technologies, Inc.·Product code HET·1994-11-30
K936181 — MIDMARK M-11 ULTRACLAVE STEAM STERILIZERMidmark Corp.·Product code FLE·1994-11-30
K936309 — DELUXE MAGMAG BREAST PUMPPigeon Corp.·Product code HGX·1994-11-30
K940079 — ARROW PERCUTANEOUS SHEATH INTRODUCER KIT AK-07903Arrow Intl., Inc.·Product code DYB·1994-11-30
K940302 — ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEMArbo Medical, Inc.·Product code DSA·1994-11-30
K941488 — DEVMED DOUBLE-BALLOON UROLOGICAL CATHETERMedical Technology Development Corp.·Product code EZL·1994-11-30
K942338 — OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESOlympus Corp.·Product code FDT·1994-11-30
K942947 — COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENICWembley Rubber Products (M) Sdn Bhd·Product code LYY·1994-11-30
K943498 — KULTSURE STARSWAB (M210), MODIFICATIONNcs Diagnostics, Inc.·Product code JSM·1994-11-30
K943499 — KULTSURE STARSWAB(M240), MODIFICATIONNcs Diagnostics, Inc.·Product code JSM·1994-11-30
K943540 — SURGICAL CUTTING BURSStryker Corp.·Product code DZJ·1994-11-30
K943622 — SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETERBoston Scientific Scimed, Inc.·Product code DQY·1994-11-30
K943707 — LATEX EXAMINATION GLOVESArista Latindo Industrial Ltd. P.T·Product code LYY·1994-11-30
K943726 — ACOUSTIC RECORDERTechnology Applications Assoc., Inc.·Product code DQC·1994-11-30
K944028 — PROCHEM CHEMISTRY ANALYZERPrisma Systems·Product code JJE·1994-11-30
K944087 — CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYSBeckman Instruments, Inc.·Product code DIO·1994-11-30
K944244 — MODEL E278OR-ASP SERIES RETRACTABLEValleylab, Inc.·Product code GEI·1994-11-30
K944254 — OKTAS STEREO VIEWING SYSTEMOktas·Product code FET·1994-11-30
K944337 — VARIOUS STETHOSCOPESRud Riester GmbH & CO KG·Product code LDE·1994-11-30
K944361 — DOCUMENT R AMMONIA/ETHANOL CONTROLCasco Standards·Product code JJX·1994-11-30
K944376 — ORION ALL SILICONE ELASTOMER COATED CATHETERRegulatory & Marketing Services, Inc.·Product code EZL·1994-11-30
K944380 — ORION FOLEY CATHETERRegulatory & Marketing Services, Inc.·Product code EZL·1994-11-30
K944381 — ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBERegulatory & Marketing Services, Inc.·Product code EZL·1994-11-30
K944606 — CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMSBeckman-Diagnostic Systems Group·Product code DJG·1994-11-30
K944649 — MILL-ROSE HARRELL BRONCHIAL BRUSHMill-Rose Laboratory·Product code EOQ·1994-11-30
K944945 — PULPDENT CALCIUM HYDROXIDE PREPARATIONSPulpdent Corp.·Product code EJK·1994-11-30
K944987 — URO - ELITE TABLE ACCESSORIESPhilips Medical Systems (Cleveland), Inc.·Product code IXR·1994-11-30
K945077 — INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.·Product code EKJ·1994-11-30
K945200 — FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCESProcter & Gamble Co.·Product code KOO·1994-11-30
K933845 — WILSON-COOK BALLOON INFLATION DEVICEWilson-Cook Medical, Inc.·Product code KNQ·1994-11-29
K941223 — ADVANCE ANALYSIS SOFTWAREGeneral Electric Co.·Product code KPS·1994-11-29
K941244 — SAFELINE SYSTEM TURN LOCK CANNULAMcgaw, Inc.·Product code FPA·1994-11-29
K941490 — BLOOD PRESSURE METER MODEL NO. BPM888Integrated Display Technology, Ltd.·Product code DXN·1994-11-29
K942649 — MINIMUS I; MINIMUS III, SANAPHONRud Riester GmbH & CO KG·Product code DXN·1994-11-29
K943320 — HEAD AND NECK COIL FOR THE GYREX 2T-DLXElscint, Inc.·Product code LNH·1994-11-29
K944162 — DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEMTeledyne Water Pik·Product code EAG·1994-11-29
K944201 — HI-Q HAND INSTRUMENTS- UROLOGYOlympus America, Inc.·Product code GCJ·1994-11-29
K944286 — METAL-LINED TRANSCEND CERAMIC BRACKETUnitek Corp.·Product code DYW·1994-11-29
K944416 — LIFESybron Dental Specialties, Inc.·Product code EJK·1994-11-29
K944427 — CARRASYN FDGCarrington Laboratories, Inc.·Product code MGQ·1994-11-29
K944468 — KERLIX ZINC SALINE DRESSINGKendall Healthcare Products Co. Div.Of Tyco Health·Product code KMF·1994-11-29

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