FDA 510(k) clearances — page 879

176,637 clearances on record, most recent first.

Clearances — page 879

87,801–87,900 of 176,637

K990185 — MDILOG, MODEL MDC-512Medtrak Technologies, Inc.·Product code CAF·1999-04-01
K990188 — INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1Intuitive Surgical, Inc.·Product code GCJ·1999-04-01
K990256 — CRX WORLD SHUNTPhoenix Biomedical Corp.·Product code JXG·1999-04-01
K990307 — OMNI-FIX, NAIL SYSTEMTurnkey Intergration USA, Inc.·Product code KTW·1999-04-01
K990322 — PERRY HUMERAL NAILPioneer Surgical Technology·Product code HSB·1999-04-01
K990352 — COULTER AC T DIFF 2 ANALYZERCoulter Corp.·Product code GKZ·1999-04-01
K990951 — MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTUREUnited States Surgical, A Division of Tyco Healthc·Product code GAM·1999-04-01
K990952 — NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURESUnited States Surgical, A Division of Tyco Healthc·Product code GAT·1999-04-01
K990086 — HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAMIntegra Lifesciences Corp.·Product code KGN·1999-03-31
K990220 — MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEMMedi-Globe Corp.·Product code FCG·1999-03-31
K990251 — DGTX FLEX REAGENT CARTRIDGE, MODEL DF36Dade Behring, Inc.·Product code LFM·1999-03-31
K990264 — COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENSMetro Optics of Austin, Inc.·Product code HQD·1999-03-31
K990311 — VEGA RETIC AUTOMATED HEMATOLOGY ANALYZERAbx Diagnostics·Product code GKZ·1999-03-31
K990354 — ENDOSHEATHVision-Sciences, Inc.·Product code EOB·1999-03-31
K990424 — ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01Bio-Rad·Product code JJY·1999-03-31
K990436 — ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEMBiodynamic Technologies, Inc.·Product code HSB·1999-03-31
K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONSEmd Chemicals, Inc.·Product code DNN·1999-03-31
K990601 — BOJRAB MICRO-TORP, MODEL 7014-5845Gyrus Ent LLC·Product code ETA·1999-03-31
K990664 — PRIMA SYSTEM - OLD, BARTELS ELISA - NEWIntracel Corp.·Product code LLH·1999-03-31
K990923 — TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010Heinz Kurz·Product code ETB·1999-03-31
K982660 — ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEMTransfusion Technologies Corp.·Product code CAC·1999-03-30
K990062 — SAPHLIFTGenzyme Surgical Product (Genzyme Biosurgery)·Product code MDM·1999-03-30
K990075 — LPULSA SYL-9000 OPHTHALMIC YAG LASERLight-Med(Usa), Inc.·Product code HQF·1999-03-30
K990278 — DAUM NEUROCUT NEUROBIOPSYNEEDLEDaum Corp.·Product code KNW·1999-03-30
K990608 — ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05Bio-Rad·Product code JJX·1999-03-30
K990703 — SPOROX II STERILIZING & DISINFECTING SOLUTIONReckitt Benckiser, Inc.·Product code MED·1999-03-30
K990708 — TITANIUM VERSALOKWrightmedicaltechnologyinc·Product code KWP·1999-03-30
K990745 — MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEMSynthes Spine·Product code MNI·1999-03-30
K990851 — INDIGO LASEROPTIC TREATMENT SYSTEMIndigo Medical, Inc.·Product code GEX·1999-03-30
K990855 — COOPERSURGICAL INFRARED COAGULATOR FOR ENTCooperSurgical, Inc.·Product code KNS·1999-03-30
K990860 — VIEWPOINT MICROSCOPE OPTIONPhilips Medical Systems (Cleveland), Inc.·Product code HAW·1999-03-30
K990868 — VIEWPOINT PASSIVE TOOL OPTIONPhilips Medical Systems (Cleveland), Inc.·Product code HAW·1999-03-30
K982641 — ADVANCED NIBP MODULEJohnson & Johnson Medical, Inc.·Product code DXN·1999-03-29
K983225 — BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANERBausch & Lomb, Inc.·Product code LPN·1999-03-29
K983496 — RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY TOpti-Centre Laboratories·Product code LPL·1999-03-29
K984039 — CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS)Cranberry (M) Sdn. Bhd.·Product code LYY·1999-03-29
K984611 — DRAGER SOLA SERIES, MODELS 1000/700/500/300Drager Medizintechnik GmbH·Product code FSY·1999-03-29
K984641 — FLEXISCOPE OPTOMODULSchoelly Fiberoptic GmbH·Product code EIA·1999-03-29
K990210 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABPMexpo Intl., Inc.·Product code LYY·1999-03-29
K990267 — POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVESShanghai Palomar Mountain Industries, Inc.·Product code LZA·1999-03-29
K990299 — POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVESShanghai Palomar Mountain Industries, Inc.·Product code LZA·1999-03-29
K990388 — TUTOPLUS IV ADMINISTRATION SETMyco Medical Supplies, Inc.·Product code FPA·1999-03-29
K990415 — LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED)La Glove (M) Sdn. Bhd.·Product code LZA·1999-03-29
K990420 — LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)La Glove (M) Sdn. Bhd.·Product code LZA·1999-03-29
K982278 — MICRINS MICRO ANASTOMOSIS CLAMPMicrins Surgical, Inc.·Product code DXC·1999-03-26
K982414 — GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERSGambro Healthcare·Product code KDI·1999-03-26
K984591 — DORNIER MEDILAS H/2Dornier Surgical Products, Inc.·Product code GEX·1999-03-26
K990050 — URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042Richard Wolf Medical Instruments Corp.·Product code FGB·1999-03-26
K990204 — GLIADIN IGG ELISA TEST SYSTEMZeus Scientific, Inc.·Product code MST·1999-03-26
K990205 — DIGISCOPE OPHTHALMIC CAMERAEye Tel Imaging, Inc.·Product code HKI·1999-03-26
K990207 — GLIADIN IGA ELISA TEST SYSTEMZeus Scientific, Inc.·Product code MST·1999-03-26
K990368 — DUODERM HYDROACTIVE GEL WOUND DRESSINGConvatec, A Bristol-Myers Squibb Co.·Product code MGQ·1999-03-26
K990556 — ESOPHAGEAL INTUBATION DETECTORWolfe Tory Medical, Inc.·Product code BTR·1999-03-26
K990657 — TRIFIX PEDICLE SPINAL SCREW ASSEMBLYCorin USA·Product code MNH·1999-03-26
K990685 — TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)Ab Biodisk·Product code JWY·1999-03-26
K990687 — HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPSOlympus Optical, Co.·Product code PKL·1999-03-26
K990786 — ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/Princeton BioMeditech Corp.·Product code LAG·1999-03-26
K990806 — C1 ULTRASOUND SYSTEMSonosite,Inc.·Product code IYN·1999-03-26
K982798 — OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMOsteonics Corp.·Product code KWQ·1999-03-25
K984618 — BCI MINI-TORR PLUS, MODEL 6004Bci Intl., Inc.·Product code DXN·1999-03-25
K990056 — JELDENT MULTICRYLJ.F. Jelenko & Co., Inc.·Product code EBI·1999-03-25
K990072 — BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION CCook Urological, Inc.·Product code EZN·1999-03-25
K990140 — NORMED BONE TRANSPORTAce Surgical Supply Co., Inc.·Product code JEY·1999-03-25
K990145 — WILSON-COOK BIPOLAR PROBEWilson-Cook Medical, Inc.·Product code KNS·1999-03-25
K990208 — PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORTScience Incorporated·Product code MEG·1999-03-25
K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETERKeeler Instruments, Inc.·Product code HKX·1999-03-25
K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSINGDermaphylyx, Inc.·Product code MGP·1999-03-25
K990456 — ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOPHollister, Inc.·Product code KPI·1999-03-25
K990518 — PEREGRINE WET SET, MODEL PD400.00Peregrine Surgical , Ltd.·Product code FRN·1999-03-25
K990551 — IGG FLEX REAGENT CARTRIDGEDade Behring, Inc.·Product code CFQ·1999-03-25
K990552 — IMMUNOGLOBULIN A TEST SYSTEMDade Behring, Inc.·Product code CFQ·1999-03-25
K990639 — ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.Guidant Corp.·Product code DQX·1999-03-25
K990783 — VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERSOrtho-Clinical Diagnostics, Inc.·Product code JJX·1999-03-25
K982136 — JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200Schiff & Co.·Product code DTN·1999-03-24
K983272 — IBC FLOPUMP, MODEL 6000International Biophysics Corp.·Product code KFM·1999-03-24
K983483 — VASCULAR OCCLUSION SYSTEMCordis Neurovascular, Inc.·Product code HCG·1999-03-24
K984062 — SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229Diag Corp.·Product code DYB·1999-03-24
K990682 — PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)Nsk Nakanishi, Inc.·Product code EKX·1999-03-24
K980737 — ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAYNichols Institute Diagnostics·Product code GGT·1999-03-23
K983229 — OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEMOlympic Medical Corp.·Product code OMA·1999-03-23
K983346 — STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOFGuidant Corp.·Product code DQX·1999-03-23
K983533 — ACTIWATCHMini-Mitter Co., Inc.·Product code GWQ·1999-03-23
K983576 — DR180-R/OXYNorth East Monitoring, Inc.·Product code FLL·1999-03-23
K983652 — ABLATOR ELECTRODELinvatec Corp.·Product code HRX·1999-03-23
K983794 — CHEMO MINI SPIKE PLUSB. Braun of America, Inc.·Product code LHI·1999-03-23
K983986 — CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATORConway Stuart Medical, Inc.·Product code GEI·1999-03-23
K984138 — APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEMZeus Scientific, Inc.·Product code LSR·1999-03-23
K984494 — RANDOX ALBUMINRandox Laboratories, Ltd.·Product code CIX·1999-03-23
K984578 — SYNERGY D2 SPINAL IMPLANTSInterpore Cross Intl.·Product code MNI·1999-03-23
K990013 — EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVESYty Industry (Manjung) Sdn Bhd·Product code LZA·1999-03-23
K990291 — LACTOSORB BONE PINBiomet, Inc.·Product code HTY·1999-03-23
K990392 — DEPUY ACE SPIDER PLATEDepuy Ace Medical Co.·Product code HRS·1999-03-23
K990448 — THE.R.MO.FREEDentamax, Inc.·Product code EBI·1999-03-23
K990691 — HERMES OPERATING ROOM CONTROL CENTERComputer Motion, Inc.·Product code GCJ·1999-03-23
K990746 — SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIMSouthland Products Co., Ltd.·Product code LYY·1999-03-23
K990751 — SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVESSouthland Products Co., Ltd.·Product code LYY·1999-03-23
K990772 — DIRECTFLOW ARTERIAL CANNULAHeartport, Inc.·Product code DWF·1999-03-23
K981858 — ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREWAtlantis Components, Inc.·Product code DZE·1999-03-22
K983007 — NEUROTUBENeuroregen, LLC·Product code JXI·1999-03-22
K983879 — ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEMAloka Co., Ltd.·Product code IYO·1999-03-22

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