FDA 510(k) clearances — page 938

176,637 clearances on record, most recent first.

Clearances — page 938

93,701–93,800 of 176,637

K970817 — MICROMARK CLIPBiopsys Medical, Inc.·Product code GDW·1997-09-11
K971869 — FINESSE ALL-CERAMIC SYSTEMDentsply Intl.·Product code EIH·1997-09-11
K972285 — GETTIG STYRL-JECT DELIVERY SYSTEMGettig Pharmaceutical Instrument Co.·Product code EJI·1997-09-11
K972320 — BIOZ SYSTEM & BIOZ PORTABLECardiodynamics International Corp.·Product code DSB·1997-09-11
K972380 — KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)Eastman Kodak Company·Product code LMB·1997-09-11
K972407 — ROOT APEX LOCATORToei Electric Co., Ltd.·Product code LQY·1997-09-11
K972435 — ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEMJohnson & Johnson Professionals, Inc.·Product code JDI·1997-09-11
K972442 — CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002Continental X-Ray Corp.·Product code JAA·1997-09-11
K972479 — ALTA PLATING SYSTEMHowmedica Corp.·Product code HRS·1997-09-11
K972644 — BREATH-SO-FRESH TONGUE CLEANERIntl. Dental Design Specialists, Inc.·Product code LCN·1997-09-11
K972666 — TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYHybritech, Inc.·Product code CIN·1997-09-11
K963373 — COSMED K4Cosmed Srl·Product code BZC·1997-09-10
K963725 — MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)Card Guard , Ltd.·Product code DXH·1997-09-10
K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMPAdroit Medical Systems, Inc.·Product code ILO·1997-09-10
K970847 — IMPULSE HVGArmstrong Industries, Inc.·Product code IPF·1997-09-10
K971425 — NARKOMED M ANESTHESIA SYSTEM (M)Draeger Medical, Inc.·Product code BSZ·1997-09-10
K971494 — VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSESZymetx, Inc.·Product code GNX·1997-09-10
K971520 — S3 CYCLIC RPM CONTROLStoeckert Instrumente·Product code DWB·1997-09-10
K972017 — BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)Minntech Corp.·Product code DTN·1997-09-10
K972211 — MULTIDOS, QC6PLUSPtw-New York Corp.·Product code LHN·1997-09-10
K972212 — 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBERPtw-New York Corp.·Product code LHN·1997-09-10
K972223 — BONE PLATE WITH CABLESPioneer Surgical Technology·Product code HRS·1997-09-10
K972243 — 2D VOG - VIDEO-OCULOGRAPHYSensomotoric Instruments, GmbH·Product code GWN·1997-09-10
K972323 — OSTEO BOS SYSTEMOsteonics Corp.·Product code HRS·1997-09-10
K972375 — IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USEGlenwood, LLC·Product code EFB·1997-09-10
K972376 — IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USEGlenwood, LLC·Product code EFB·1997-09-10
K972412 — PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESHETHICON, Inc.·Product code FTL·1997-09-10
K972429 — INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9Custom Services Intl., Inc.·Product code LTZ·1997-09-10
K972430 — EXTRAWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9Custom Services Intl., Inc.·Product code LTZ·1997-09-10
K973199 — AMSINO SUCTION CATHETERAmsino Intl., Inc.·Product code BSY·1997-09-10
K973259 — K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)Medical Creative Technologies, Inc.·Product code OCZ·1997-09-10
K950260 — QUICK COUPLING DEVICE FOR DENTAL PROSTHESESDr. Joseph E. Grasso, D.D.S.·Product code DZE·1997-09-09
K950261 — DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESESDr. Joseph E. Grasso, D.D.S.·Product code DZE·1997-09-09
K961381 — KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERSThe Emerging Technologies Group·Product code DZE·1997-09-09
K963196 — VYGON UMBILICAL CATHETHER INSERTION TRAYVygon Corp.·Product code FOZ·1997-09-09
K970585 — FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITORFukuda Denshi USA, Inc.·Product code DSI·1997-09-09
K970591 — BLOOD MONITOR PUMPBaxter Healthcare Corp·Product code KDI·1997-09-09
K971640 — LEADCARE BLOOD LEAD TESTING SYSTEMEsa, Inc.·Product code DOF·1997-09-09
K972187 — BOUFFANT CAPAmerican Seal Co.·Product code KKX·1997-09-09
K972220 — RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KITRandox Laboratories, Ltd.·Product code DHR·1997-09-09
K972227 — SHOE COVERAmerican Seal Co.·Product code FYF·1997-09-09
K972316 — OPUS D-DIMERBehring Diagnostics, Inc.·Product code GHH·1997-09-09
K972455 — JIMMY JOHN III RECTAL NOZZEL, MODEL CITColon Therapeutics·Product code KPL·1997-09-09
K972523 — PUNCTUAL OCCLUDEROdyssey Medical, Inc.·Product code LZU·1997-09-09
K972706 — CLINITEK MICROALBUMIN REAGENT STRIPSBayer Corp.·Product code CJG·1997-09-09
K972733 — AVL OMNI ANALYZERAvl Scientific Corp.·Product code CGA·1997-09-09
K960527 — LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEMGE Medical Systems·Product code IYN·1997-09-08
K963354 — 5 STAR MEDICAL ENDOSCOPEFive Star Medical, Inc.·Product code ODF·1997-09-08
K964238 — AIRCAST VENA FLOW STERILE DISPOSABLE CUFFSAircast, Inc.·Product code JOW·1997-09-08
K964597 — BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGEBiosurgical Corp.·Product code FMF·1997-09-08
K971023 — CHASE THORACIC CATHETERChase Medical, Inc.·Product code DWF·1997-09-08
K971624 — DYE STOP AND SAVE - QUICKFILLShepherd Laboratories, Inc.·Product code FPA·1997-09-08
K972030 — STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUSOxoid , Ltd.·Product code JWX·1997-09-08
K972191 — DIGITIZER DIRECTOR (HSC025-01)Howtek, Inc.·Product code LMD·1997-09-08
K972221 — K 15 AUDIOMETERAmerican Electromedics Corp.·Product code EWO·1997-09-08
K972275 — LANTIS TREATSTATIONSiemens Medical Solutions USA, Inc.·Product code IYE·1997-09-08
K972485 — CIMPAT NArent, Fox, Kintner, Plotkin & Kahn·Product code EMA·1997-09-08
K972509 — CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTERNuccardiac Software, Inc.·Product code KPS·1997-09-08
K972519 — GRASPING FORCEPS, RIGHT AND LEFT CURVEDRichard Wolf Medical Instruments Corp.·Product code GEI·1997-09-08
K972524 — DRIED GRAM-POSITIVE MIC/COMBO PANELSDade Intl., Inc.·Product code JWY·1997-09-08
K972688 — MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACINDade Microscan, Inc.·Product code JWY·1997-09-08
K972776 — DRY & STOREEar Technology Corp.·Product code ESD·1997-09-08
K972855 — KARL STORZ CONTACT NASAL MICRO-ENDOSCOPESKARL STORZ Endoscopy-America, Inc.·Product code EOB·1997-09-08
K970159 — FLEX-NECK PD CATHETERJanin Group, Inc.·Product code FJS·1997-09-05
K970464 — P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1Northwest Medical Physics Equipment, Inc.·Product code IYE·1997-09-05
K970468 — KT AIR BEDKinetic Concepts, Inc.·Product code FNM·1997-09-05
K970808 — MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASERContinuum Biomedical, Inc.·Product code GEX·1997-09-05
K971356 — POWDER FREE SYNTHETIC EXAMINATION GLOVESArista Latindo Industrial Ltd. P.T·Product code LZA·1997-09-05
K971492 — AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATORBei Medical Systems Co., Inc.·Product code HIG·1997-09-05
K971919 — EZCHEK/HBA BLOOD COLLECTION KITFlexsite Diagnostics, Inc.·Product code LCP·1997-09-05
K972163 — IMATION SE-196 LASER IMAGERImation Corp.·Product code LMC·1997-09-05
K972168 — SIDEXIS DIGITAL RADIOGRAPHY SYSTEMPelton & Crane Co.·Product code EHD·1997-09-05
K972178 — UNISURGE INTERFACE PUnisurge Holding, Inc.·Product code GCJ·1997-09-05
K972193 — OLYMPIX MINI-PASTEURMATIC (58210)Olympic Medical Corp.·Product code LDS·1997-09-05
K972205 — ALPHA 7000 QUADRATURE WRIST COILUsa Instruments, Inc.·Product code MOS·1997-09-05
K972210 — RESECTOSCOPE SAFETY SHEATHConceptus, Inc.·Product code HIH·1997-09-05
K972453 — XPS STRAIGHTSHOT MICRORESECTORXomed, Inc.·Product code ERL·1997-09-05
K972533 — VERA SOLDERAalba Dent, Inc.·Product code EJS·1997-09-05
K972534 — ALFALLOYAalba Dent, Inc.·Product code EJS·1997-09-05
K972734 — PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)Mednet Locator, Inc.·Product code ETB·1997-09-05
K972735 — TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)Mednet Locator, Inc.·Product code ETA·1997-09-05
K972737 — CAUSSE PISTONMednet Locator, Inc.·Product code ETB·1997-09-05
K972950 — HIPALLAUR 19Aurex Precious Metal Industries (Pty)Ltd·Product code EJT·1997-09-05
K972951 — HIPALLAUR 51Aurex Precious Metal Industries (Pty)Ltd·Product code EJT·1997-09-05
K972952 — AUREBOND 51Aurex Precious Metal Industries (Pty)Ltd·Product code EJT·1997-09-05
K972953 — PALAUREX 76KFAurex Precious Metal Industries (Pty)Ltd·Product code EJT·1997-09-05
K972954 — PALAUREX 78Aurex Precious Metal Industries (Pty)Ltd·Product code EJT·1997-09-05
K972955 — PALCERAM 56Aurex Precious Metal Industries (Pty)Ltd·Product code EJT·1997-09-05
K972956 — PALCERAM 82SFAurex Precious Metal Industries (Pty)Ltd·Product code EJT·1997-09-05
K972998 — PRISMASiemens Hearing Instruments, Inc.·Product code ESD·1997-09-05
K964815 — AP-4000, AIR PULSE SENSORY STIMULATORPentax Precision Instrument Corp.·Product code LLN·1997-09-04
K970627 — E. CAM COINCIDENCE MODE (CM)Siemens Medical Solutions USA, Inc.·Product code KPS·1997-09-04
K971260 — SULLIVAN HUMIDAIRE HEATED HUMIDIFIERResmed Corp·Product code BTT·1997-09-04
K971487 — BKMI DISPOSABLE SYRINGESumi Salud C.A.·Product code FMI·1997-09-04
K972364 — UNICAP PHADIATOPPharmacia, Inc.·Product code DHB·1997-09-04
K972367 — STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTStryker Instruments·Product code KIJ·1997-09-04
K972441 — RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000Radiotherapeutics Corp.·Product code GEI·1997-09-04
K972516 — SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEMSynthes (Usa)·Product code JDS·1997-09-04
K973030 — VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300)Johnson & Johnson Clinical Diagnostics, Inc.·Product code JJY·1997-09-04
K973222 — SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTERSiemens Medical Solutions USA, Inc.·Product code DQA·1997-09-04

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