FDA 510(k) clearances — page 1240

176,637 clearances on record, most recent first.

Clearances — page 1240

123,901–124,000 of 176,637

K902627 — INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH.Biometric Research Institute, Inc.·Product code KRB·1991-02-25
K902628 — INTERFLO MEDICAL MODEL INTERFLO/1 CARDIAC OUTPUTBiometric Research Institute, Inc.·Product code DXG·1991-02-25
K903991 — PCM ANESTHESIASiemens Life Support Systems·Product code BSZ·1991-02-25
K904117 — SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.Dawn Medical·Product code BZG·1991-02-25
K904118 — SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.Dawn Medical·Product code BZG·1991-02-25
K904250 — MODEL 4222 AMBULATORY ECG MONITORByrncrest Global, Inc.·Product code DXH·1991-02-25
K904406 — EER ERECTION ENHANCED RESPONDEREer, Inc.·Product code LKY·1991-02-25
K904582 — QUICKWIRE - HYDROPHILIC COATED GUIDEWIREMeadox Surgimed, Inc.·Product code DQX·1991-02-25
K904975 — VISTA VIEWING STATIONPrism Imaging, Inc.·Product code DXK·1991-02-25
K904976 — CINE'VIEW - STRESS ECHO & IMAGE REVIEWPrism Imaging, Inc.·Product code DXK·1991-02-25
K904977 — CINE/VIEW PLUS - CARDIOLOGY WORKSTATIONPrism Imaging, Inc.·Product code DXK·1991-02-25
K904978 — SOFTWARE PROGRAM USED W/PRISM PRODUCTSPrism Imaging, Inc.·Product code DXK·1991-02-25
K905139 — CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETERCathlab Corp.·Product code DXE·1991-02-25
K905294 — EUB-315Hitachi Medical Corp. of America·Product code IYO·1991-02-25
K905548 — PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIREMallinckrodt Medical·Product code DQX·1991-02-25
K905686 — SARNS TEMPERATURE PROBE AND CONNECTOR3M Health Care, Sarns·Product code DWE·1991-02-25
K905765 — PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES)Tillotson Rubber Co., Inc.·Product code LYY·1991-02-25
K905832 — MRP -5000(1): VERSION 2.0 SOFTWARESummit World Trade Corp.·Product code LNH·1991-02-25
K905833 — MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHYSummit World Trade Corp.·Product code LNH·1991-02-25
K910112 — BIFURCATED VS-1 TO VS-1 LEAD ADAPTORTelectronics Pacing Systems, Inc.·Product code DTD·1991-02-25
K910205 — LP-60 LOW PRESSURE INFLATION DEVICEDevices For Vascular Intervention, Inc.·Product code MAV·1991-02-25
K910237 — MODIFIED MODEL 5330 AV DEMAND PULSE GENERATORMedtronic Vascular·Product code DTE·1991-02-25
K910345 — ANTIMICROBIAL CEFOPERAZONEAlamar·Product code JWY·1991-02-25
K910346 — ANTIMICROBIAL CEFTRIAXONEAlamar·Product code JWY·1991-02-25
K910439 — FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM)Lowenkamp Intl., Inc.·Product code LYY·1991-02-25
K900677 — ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETERCook, Inc.·Product code LIT·1991-02-22
K905623 — CK-MB IMMUNOASSAY CONTROLSeradyn, Inc.·Product code JJT·1991-02-22
K910256 — ECLIPSE ICA TSHBiotope, Inc.·Product code JLW·1991-02-22
K910302 — ECLIPSE ICA ANALYZERBiotope, Inc.·Product code JJQ·1991-02-22
K910376 — EMIT II BENZODIAZEPINE ASSAYSyva Co.·Product code JXM·1991-02-22
K903485 — TITANIUM MESHRuggles Corp.·Product code GWO·1991-02-21
K904638 — TROCAR DISPOSABLEL.A.S.E.R., Inc.·Product code FBQ·1991-02-21
K904957 — STERILE AND NON-STERILE TEXTILE PACKSSurgical Pack Services, Inc.·Product code KKX·1991-02-21
K904973 — EXTERNAL FIXATIONDynasplint Systems, Inc.·Product code KTT·1991-02-21
K905004 — BIO-GUARD O.R. SCRUB PREP TRAYNetwork Medical Systems, Inc.·Product code LRO·1991-02-21
K905006 — SURGILASE SL 150 SURGICAL LASER SYSTEMSurgilase, Inc.·Product code GEX·1991-02-21
K905209 — SURGICAL MASKLancaster County Blind Assoc.·Product code FXX·1991-02-21
K905433 — CODMAN DISPOSABLE SCALP CLIP APPLIERCodman & Shurtleff, Inc.·Product code HBO·1991-02-21
K905529 — VALLEYLAB E1554 REDUCED ESCHAR ELECTRODEValleylab, Inc.·Product code GEI·1991-02-21
K905564 — PREP AND OPERATING STANDMcconnell Orthopedic·Product code FWZ·1991-02-21
K905565 — LATERAL BUTTRESS SUPPORTMcconnell Orthopedic·Product code FWZ·1991-02-21
K905612 — VENTREX COATED TUBE IGE RADIOIMMUNOASSAYVentrex Laboratories, Inc.·Product code DGC·1991-02-21
K905625 — CVIS INSIGHT IMAGING CATHETERCardiovascular Imaging Systems, Inc.·Product code DQO·1991-02-21
K905710 — PHARMACIA DELFIA NEONATAL HTSH KITPharmacia, Inc.·Product code JLW·1991-02-21
K905721 — OPUS GENTAMICINPb Diagnostic Systems, Inc.·Product code LCQ·1991-02-21
K905790 — TOTAL PROTEIN REAGENT SETBiochemical Trade, Inc.·Product code CEK·1991-02-21
K910042 — EBV IGM ELISA TESTGull Laboratories, Inc.·Product code LJN·1991-02-21
K910132 — STRYKER LAPAROSCOPEStryker Corp.·Product code GCJ·1991-02-21
K910184 — PLP LAPAROSCOPIC CHOLECYSTECTOMY DIS. ELEC. PROBESPrecision Laser Products, Inc.·Product code GEI·1991-02-21
K910334 — ELECTROCAUTERY PROBEWiltek Medical, Inc.·Product code GEI·1991-02-21
K910607 — PACIFIC MARQUIS SPAMarquis International , Ltd.·Product code ILJ·1991-02-21
K900179 — SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTSCore-Vent Corp.·Product code DZE·1991-02-20
K900181 — MICRO-VENT ENDOSSEOUS IMPLANT ABUTMENTSCore-Vent Corp.·Product code DZE·1991-02-20
K901287 — INTHERM TEMPORARY OCCLUSION CATHETERInterventional Therapeutics Corp.·Product code DYG·1991-02-20
K902435 — DIA IMPRESSION COPINGDental Imaging Assoc., Inc.·Product code DZE·1991-02-20
K905163 — NITRATE DISKRemel Co.·Product code JTO·1991-02-20
K905213 — MIDDLE EAR ANALYZER, MODEL AE-803American Electromedics Corp.·Product code ETY·1991-02-20
K905401 — ASEPTIMINI UNIT, ADU-10Aseptico, Inc.·Product code EIA·1991-02-20
K905476 — STOMADENT TMDentsply Intl.·Product code EBF·1991-02-20
K905524 — RETIC-CHEXStreck Laboratories, Inc.·Product code JPK·1991-02-20
K905639 — TORQUE HANDLE DEVICE FOR GUIDEWIRELake Region Mfg., Inc.·Product code DQX·1991-02-20
K910038 — LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEMWalter Lorenz Surgical, Inc.·Product code JEY·1991-02-20
K910115 — PHILIPS BV-29 IMAGING SYSTEMPhilips Medical Systems, Inc.·Product code OXO·1991-02-20
K900180 — CORE-VENT ENDOSSEOUS IMPLANT ABUTMENTSCore-Vent Corp.·Product code DZE·1991-02-19
K900723 — ITC BUNJI COILInterventional Therapeutics Corp.·Product code HCG·1991-02-19
K903131 — LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEMLasermatic, Inc.·Product code GEX·1991-02-19
K903321 — SANDBOX I, SANDBOX II, SANDBOX JR.Sandbox Ent.·Product code IRT·1991-02-19
K903771 — HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULEHewlett-Packard Co.·Product code DXN·1991-02-19
K904000 — TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBRArmkel, LLC·Product code HIS·1991-02-19
K904169 — VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLYVarian Canada, Inc.·Product code IZO·1991-02-19
K904240 — SINGLE USE LAPARSCOPIC ELECTRODEAspen Labs·Product code HFG·1991-02-19
K904266 — AUTODERM SCANNER CONTROL CONSOLECharles I. Rose & Co., Inc.·Product code GEX·1991-02-19
K904691 — AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYSTAir-Shields Vickers, Inc.·Product code HFM·1991-02-19
K904700 — ENDOCOAGULATOR KRS568(TM) LASERHgm Medical Laser Systems, Inc.·Product code GEX·1991-02-19
K905212 — IMMITTANCE METER, MODEL AE-105D/SAmerican Electromedics Corp.·Product code ETY·1991-02-19
K905249 — NEW USCI 7F PTCA GUIDING CATHETERC.R. Bard, Inc.·Product code DQY·1991-02-19
K905279 — CONDOM (RUBBER) CONTRACEPTIVEAladan Corp.·Product code HIS·1991-02-19
K905295 — CATALOG NUMBER 2609 LEG PLATEGe Medical Systems Information Technologies·Product code HGM·1991-02-19
K905314 — ALGODERM ALGINATE WOUND DRESSINGLes Laboratorires Brothier, S.A.·Product code FRO·1991-02-19
K905549 — THE DARTDexide, Inc.·Product code HIF·1991-02-19
K905581 — SILICONE COATED GUIDEWIRESLake Region Mfg., Inc.·Product code DQX·1991-02-19
K905641 — FST CATH-UD CATHETERFiberoptic Sensor Technlogies, Inc.·Product code FEN·1991-02-19
K905682 — RICHARD-ALLAN CLAMP COVERSRichard-Allan Medical·Product code FSM·1991-02-19
K905701 — RICHARD-ALLAN SHEET CLIPRichard-Allan Medical·Product code KKX·1991-02-19
K905718 — ROMFLEXParaflex Corp.·Product code BXB·1991-02-19
K905724 — IONOBONDMicro-Vac, Inc.·Product code EJK·1991-02-19
K905834 — MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHYSummit World Trade Corp.·Product code LNH·1991-02-19
K905835 — MRP-7000: SUPPLEMENTAL R/F COILSSummit World Trade Corp.·Product code LNH·1991-02-19
K910357 — SOM 6VJedmed Instrument Co.·Product code FSO·1991-02-19
K910456 — ZARA CHIN IMPLANTByron Medical·Product code FWP·1991-02-19
K910457 — ZARA EXTENDED CHIN IMPLANTByron Medical·Product code FWP·1991-02-19
K910458 — ZARA SOFT TIP CHIN IMPLANTByron Medical·Product code FWP·1991-02-19
K910495 — QUALTEX SURGICAL DRAPEDeroyal Industries, Inc.·Product code KKX·1991-02-19
K910512 — ACCUFLATEInstrumed, Inc.·Product code KCY·1991-02-19
K910542 — DIGIFLEX, LATEX PATIENT EXAMINATION GLOVES21st Century Group·Product code LYY·1991-02-19
K902256 — IRRIGATION CATHETER 4, 6 AND 10 FRENCHApplied Vascular Devices, Inc.·Product code DQY·1991-02-15
K904404 — MULTI-LUMEN CENTRAL VENOUS CATHETER SETArrow Intl., Inc.·Product code DQY·1991-02-15
K905184 — ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOKAcromed Corp.·Product code KWP·1991-02-15
K905186 — GERI TOTAL HIP SYSTEMSmith & Nephew Richards, Inc.·Product code LWJ·1991-02-15
K905188 — PERIO PIKTeledyne Water Pik·Product code EFS·1991-02-15

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