FDA 510(k) clearances — page 970

176,637 clearances on record, most recent first.

Clearances — page 970

96,901–97,000 of 176,637

K962641 — MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBERMedtronic Vascular·Product code DTZ·1996-12-16
K962917 — MULTIDEX HYDROPHILIC WOUND DRESSING GELLange Medical Products, Inc.·Product code MGQ·1996-12-16
K963094 — CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASERCynosure, Inc.·Product code GEX·1996-12-16
K963127 — ELECSYS FT3Boehringer Mannheim Corp.·Product code CDP·1996-12-16
K963296 — INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)Incstar Corp.·Product code LGD·1996-12-16
K963297 — INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)Incstar Corp.·Product code LGD·1996-12-16
K963539 — SIGMA DIAGNOSTICS WASH CONCENTRATESigma Diagnostics, Inc.·Product code JJE·1996-12-16
K963633 — VENTNET; CENTRAL MONITORING STATIONPuritan Bennett Corp.·Product code MOD·1996-12-16
K963747 — REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.Whitehill Manufacturing, Inc.·Product code JET·1996-12-16
K963884 — SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350Somnus Medical Technologies, Inc.·Product code GEI·1996-12-16
K963910 — HEART NEBULIZER #100609Vortran Medical Technology 1, Inc.·Product code CAF·1996-12-16
K963934 — ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329Bio-Rad Laboratories, Inc.·Product code MMI·1996-12-16
K963973 — DEPUY CANNULATED CROSS PIN SCREW SYSTEMDepuy, Inc.·Product code JDW·1996-12-16
K964007 — ACROMED CABLE/WIRE PEDICLE SCREWAcromed Corp.·Product code MNH·1996-12-16
K964100 — VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100Vision-Sciences, Inc.·Product code FAM·1996-12-16
K964111 — LITHOVAC SUCTION/ASPIRATION PROBEElectro Medical Systems SA·Product code KQT·1996-12-16
K964323 — CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIALFen Dental Mfg., Inc.·Product code ELW·1996-12-16
K964345 — ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYEDETHICON, Inc.·Product code GAM·1996-12-16
K964558 — VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)Johnson & Johnson Clinical Diagnostics, Inc.·Product code JLW·1996-12-16
K964687 — N LATEX CRP MONO REAGENTBehring Diagnostics, Inc.·Product code DCH·1996-12-16
K964693 — ELECSYS FSH ASSAYBoehringer Mannheim Corp.·Product code CGJ·1996-12-16
K964705 — SOLDER GPYGateway Alloys, Inc.·Product code EJS·1996-12-16
K964706 — SOLDER 650Gateway Alloys, Inc.·Product code EJS·1996-12-16
K964707 — SOLDER 585Gateway Alloys, Inc.·Product code EJS·1996-12-16
K964708 — SOLDER 615Gateway Alloys, Inc.·Product code EJT·1996-12-16
K964713 — SOLDER GPWGateway Alloys, Inc.·Product code EJS·1996-12-16
K964829 — ELECSYS CALCHECK FSHBoehringer Mannheim Corp.·Product code JIX·1996-12-16
K964830 — ELECSYS CALCHECK LHBoehringer Mannheim Corp.·Product code JJX·1996-12-16
K964835 — COVERAGE SPRAY HBVConvatec, A Division of E.R. Squibb & Sons·Product code LRJ·1996-12-16
K961687 — EVITA 4Drager, Inc.·Product code CBK·1996-12-13
K962212 — KARL STORZ FRIMBERGER VARIOGUIDEKARL STORZ Endoscopy-America, Inc.·Product code FDT·1996-12-13
K962968 — PROC APC ASSAY, PROC CONTROL PLASMABehring Diagnostics, Inc.·Product code GGP·1996-12-13
K963062 — IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2Beckman Instruments, Inc.·Product code KXT·1996-12-13
K963707 — NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)Nellcor Puritan Bennett, Inc.·Product code DQA·1996-12-13
K963733 — NICCHECK IDynagen, Inc.·Product code MRS·1996-12-13
K963849 — MANAN D BAGManan Medical Products, Inc.·Product code EXF·1996-12-13
K964068 — CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEMBayer Corp.·Product code KLT·1996-12-13
K964158 — JEL-40 (CODE NAME RD-0430)Jelenko Co.·Product code EJT·1996-12-13
K964173 — C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZRichard Wolf Medical Instruments Corp.·Product code FET·1996-12-13
K964328 — SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATESynthes (Usa)·Product code JEY·1996-12-13
K964355 — ONTRAK TESTCUP 5 (MODIFICATION)Roche Diagnostic Systems, Inc.·Product code LCM·1996-12-13
K964415 — N-ASSAY TIA RHEUMATOID FACTOR TEST KITKamiya Technology Services·Product code DHR·1996-12-13
K964418 — N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SETKamiya Technology Services·Product code DHR·1996-12-13
K964535 — VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANTS.C. Johnson & Son, Inc.·Product code LRJ·1996-12-13
K964610 — TRIAD II DISINFECTANT CLEANER AND DEODORANTS.C. Johnson & Son, Inc.·Product code LRJ·1996-12-13
K964613 — VIREX II 256 GERMICIDAL CLEANER AND DEODORANTS.C. Johnson & Son, Inc.·Product code LRJ·1996-12-13
K964640 — CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92Canyon Diagnostics, Inc.·Product code JJY·1996-12-13
K964749 — COVERAGE HBVConvatec, A Division of E.R. Squibb & Sons·Product code LRJ·1996-12-13
K962447 — EQUINOX DIGITAL EEG SYSTEMPhysiometrix, Inc.·Product code GWQ·1996-12-12
K962528 — OLYMPUS MOBILE CHAIR/COUCHKeymed (Medical & Industrial Equipment), Ltd.·Product code FZK·1996-12-12
K962612 — BILIBED PHOTOTHERAPY LAMPMedela, Inc.·Product code LBI·1996-12-12
K963669 — GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEMAstro-Med, Inc.·Product code GWL·1996-12-12
K963679 — LOVING SMARTER - SAFER SEXLoving Smarter, Inc.·Product code HIS·1996-12-12
K963689 — RECOVER ADULT VEIN WARMERFlorida Medical Industries, Inc.·Product code IMD·1996-12-12
K963691 — COURIER BALLOON DILATATION CATHETERBoston Scientific Corp·Product code FGE·1996-12-12
K963728 — THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUSChina Chongqing Bashan Instrument Factory·Product code ILY·1996-12-12
K963746 — IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORIDWhitehill Oral Technologies, Inc.·Product code JES·1996-12-12
K963802 — SHUNT TAPIntegra Neurocare, LLC·Product code JXG·1996-12-12
K963806 — CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)Bmw Medical, Inc.·Product code LJS·1996-12-12
K963824 — LI'S ITCH STOPPERHontech Foundation For Medical Technology·Product code IRT·1996-12-12
K963839 — CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.·Product code GCY·1996-12-12
K963963 — MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSISBecton Dickinson Immunocytometry Systems·Product code GKZ·1996-12-12
K963979 — ULTRADENT UNIVERSAL DENTIN SEALANTUltradent Products, Inc.·Product code LBH·1996-12-12
K963988 — INTRAVASCULAR INFUSION DEVICEBoston Scientific Corp·Product code KRA·1996-12-12
K964071 — ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOROratec Interventions, Inc.·Product code GEI·1996-12-12
K964123 — REUSABLE TROCAR WITH SLEEVE (COMMON)Pilling Weck Group·Product code GCJ·1996-12-12
K964241 — BRENNEN MEDICAL GLUCAN II WOUND DRESSINGBrennen Medical, Inc.·Product code MGQ·1996-12-12
K964429 — SUNGLASSES OR MULTIPLETrade Resources , Ltd.·Product code HQY·1996-12-12
K964683 — DIGIFOCUS ITEOticon, Inc.·Product code ESD·1996-12-12
K950719 — OES UROLOGYOlympus America, Inc.·Product code EZO·1996-12-11
K962855 — ULE-2, MULE-2, HAND ACCESSORY KITPenny and Giles Biometrics , Ltd.·Product code ISD·1996-12-11
K963159 — CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODESCmc Sense-It, Inc.·Product code DRX·1996-12-11
K964469 — 700-F SERIES STIMULATION ELECTRODESCardiotronics Systems, Inc.·Product code LDD·1996-12-11
K954505 — EZ STIMLife-Tech Intl., Inc.·Product code KOI·1996-12-10
K954523 — THERMOSCAN INSTANT THERMOMETER MODEL IR-6000Thermoscan, Inc.·Product code FLL·1996-12-10
K955031 — MAXISTIMLife-Tech Intl., Inc.·Product code KOI·1996-12-10
K960734 — HAEMOCELL SYSTEM 350 OR S350Haemocell Plc·Product code CAC·1996-12-10
K960771 — SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEMRymed Technologies, Inc.·Product code FPA·1996-12-10
K961138 — ESORT II + 400 SERIES MONITORMedical Data Electronics·Product code DRO·1996-12-10
K961223 — MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMSCriticare Systems, Inc.·Product code LOS·1996-12-10
K961908 — THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451Helena Laboratories·Product code JPA·1996-12-10
K961984 — PORPHOBILINOGEN (PBG)Trace America, Inc.·Product code JNF·1996-12-10
K962598 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KITNichols Institute Diagnostics·Product code CEW·1996-12-10
K962625 — VITAJETVitajet Corp.·Product code KZE·1996-12-10
K962734 — CEDIA DAU BENZODIAZEPINE ASSAYBoehringer Mannheim Corp.·Product code JXM·1996-12-10
K962915 — ACTIS (VENOUS FLOW CONTROLLER)Vivus, Inc.·Product code LKY·1996-12-10
K963692 — VERDICT PCPEditek, Inc.·Product code LCM·1996-12-10
K963835 — DIGOXIN ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.·Product code KXT·1996-12-10
K963852 — KSEA THERMOCOAGULATOR (MODEL 265100 20)KARL STORZ Endoscopy-America, Inc.·Product code HGI·1996-12-10
K963924 — LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70Pari Holding Co.·Product code CAF·1996-12-10
K964775 — ARDENT FUTURA NON GAMMA-2Ardent Production Development·Product code EJJ·1996-12-10
K953990 — TRANSFLOW TESTP.K. Morgan , Ltd.·Product code BZC·1996-12-09
K961643 — MEDICOTEST ECG ELECTRODESMedicotest, Inc.·Product code DRX·1996-12-09
K961937 — SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEMDelphi Consulting Group·Product code DQD·1996-12-09
K962314 — HALIFAX PLUS INTERLAMINAR CLAMP SYSTEMOsteonics Corp.·Product code KWP·1996-12-09
K962608 — SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTORSynthes (Usa)·Product code MNH·1996-12-09
K962661 — ML MICROKERATOME BLADEMed-Logics, Inc.·Product code HNO·1996-12-09
K962880 — SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMSherwood Medical Co.·Product code CAZ·1996-12-09
K963204 — DMS-1000C DERMOABRADERAesthetic Lasers, Inc.·Product code GFE·1996-12-09
K963796 — KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERSHowmedica Corp.·Product code JWH·1996-12-09

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