FDA 510(k) clearances — page 1425

176,637 clearances on record, most recent first.

Clearances — page 1425

142,401–142,500 of 176,637

K861515 — OSTEOPAK BMD (BONE MINERAL DENSITOMETER)Siemens Gammasonics, Inc.·Product code KGI·1987-02-02
K862859 — EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUNDBiosound, Inc.·Product code DXK·1987-02-02
K863776 — MICRODILUTION MIC PANELSAmerican Micro Scan·Product code JWY·1987-02-02
K864315 — CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAYCytotech, Inc.·Product code LFX·1987-02-02
K864347 — INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCAGranbio, Inc.·Product code GNP·1987-02-02
K864396 — LYMPHOCYTE MAINTENANCE MEDIUMBioclinical Laboratory Services, Inc.·Product code KIT·1987-02-02
K864400 — EXTRA STRONG CONDOMAnsell, Inc.·Product code HIS·1987-02-02
K864420 — CMV MICROASSAYDiamedix Corp.·Product code GQI·1987-02-02
K864443 — EGG-TOP TORP AND EGG-TOP PORPRichards Medical Co., Inc.·Product code ETA·1987-02-02
K864449 — DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KITCanadian Bioclinical, Ltd.·Product code DPO·1987-02-02
K864452 — DELFIA(TM) TRIIODOTHYRONINE (T3) KITLkb Instruments, Inc.·Product code CDP·1987-02-02
K864493 — REVISED RESISTANT 5 MIC PANELPasco Laboratories, Inc.·Product code JWY·1987-02-02
K864524 — SPERM SELECT(TM)Pharmacia, Inc.·Product code MQL·1987-02-02
K864548 — ALFERR TIBC TUBEBenchmark Reagents·Product code JQE·1987-02-02
K864604 — EBV VCA IGM ANTIBODY ASSAY KITGranbio, Inc.·Product code LJN·1987-02-02
K864657 — ATL'S ULTRAMARK 6 ULTRASOUND SYSTEMAdvanced Technology Laboratories, Inc.·Product code DXK·1987-02-02
K864663 — PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEMKallestad Diag, A Div. of Erbamont, Inc.·Product code LJP·1987-02-02
K865020 — SERA-TEK THYROGLOBULIN ANTIBODY TESTMiles Laboratories, Inc.·Product code DDC·1987-02-02
K870032 — REVISED T-SCAN SYSTEMSentek, Inc.·Product code EFH·1987-02-02
K864173 — HPD HUMIDIFYING CHAMBERHpd Medical, Inc.·Product code BTT·1987-01-30
K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENTAngiomed U.S., Inc.·Product code FAD·1987-01-30
K864408 — EMG-1, MOTOR NERVE MONITORAlgotek, Inc.·Product code IKN·1987-01-30
K864837 — MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARMOec-Diasonics, Inc.·Product code JAA·1987-01-30
K864903 — MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULASalter Labs·Product code CCK·1987-01-30
K864958 — ALPHA II DIAGNOSTIC X-RAYAusonics Pty , Ltd.·Product code IZH·1987-01-30
K850100 — BLOOD LANCETGainor Medical·Product code FMK·1987-01-29
K863985 — EVOPORT 100Jedmed Instrument Co.·Product code GWJ·1987-01-29
K864345 — NTE-2 THERMAL SENSITIVITY TESTERSensortek, Inc.·Product code LQW·1987-01-29
K870047 — COLTENE RAPIDColtene, Inc.·Product code ELW·1987-01-29
K863866 — RESPIRADYNE II(TM)Chesebrough-Pond'S U.S.A. Co.·Product code BZK·1987-01-28
K864005 — ALPINEMountain Medical Equipment, Inc.·Product code CAW·1987-01-28
K864085 — BROOKER BIO-GROOVE FEMORAL COMPONENTBiomet, Inc.·Product code KWL·1987-01-28
K864103 — CURITY ANESTHESIA FILTERThe Kendal Co.·Product code CAH·1987-01-28
K864280 — ECONOL (PORTABLE) ECONO 30 & 40 LITER BASE UNITSmith-Taylor Mfg. Co., Div. Allied Medical Corp.·Product code BYJ·1987-01-28
K864487 — LIFEWATCH SENSOR BELTLifewatch Systems, Inc.·Product code BZQ·1987-01-28
K864641 — VENTEX-IAVentech Corp.·Product code IKN·1987-01-28
K864750 — KOTEX SECURITY TAMPONS, REGULAR AND SUPERKimberly-Clark Corp.·Product code HEB·1987-01-28
K864883 — NEONATAL CANNULA CAPBehan & Taylor Ent.·Product code BZD·1987-01-28
K864902 — MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.Salter Labs·Product code CCK·1987-01-28
K864929 — HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYSTHall Surgical, Division of Zimmer, Inc.·Product code HWE·1987-01-28
K864934 — 'EXMOOR' SHAH SILICONE DISCSExmoor Plastics , Ltd.·Product code EPP·1987-01-28
K864935 — 'EXMOOR' SHAH PACKING STRIPSExmoor Plastics , Ltd.·1987-01-28
K870043 — GUO GUANG WHEEL CHAIRChina National Medicines & Health Prod. I/E Corp.·Product code IOR·1987-01-28
K870084 — RD 140 SURGICAL BENDERTerray Manufacturing, Inc.·Product code HXW·1987-01-28
K870100 — PLASTER STANDOrthopedic Systems, Inc.·Product code LGG·1987-01-28
K861069 — TECA NEUROPTO WITH OS-5 STIMULATORTeca, Inc.·Product code GWE·1987-01-27
K863711 — REGULATOR OXYGEN MECHANICALLifeguard Medical Products, Inc.·Product code CAN·1987-01-27
K864070 — WHITESIDE ORTHOLOC (TM)Dow Corning Wright·Product code HRY·1987-01-27
K864135 — 280SL IMAGING SYSTEM SMALL PARTS PROBESGe Medical Systems Information Technologies·Product code ITX·1987-01-27
K864136 — 260SL IMAGING SYSTEM SMALL PARTS PROBESGe Medical Systems Information Technologies·Product code ITX·1987-01-27
K864447 — NARKOMED 2B ANESTHESIA SYSTEMDraeger Medical, Inc.·Product code BSZ·1987-01-27
K864498 — O.B.(TM) TAMPONPersonal Products Co.·Product code HIL·1987-01-27
K862755 — DUNN ANTERIOR DISTRACTION SYSTEMOsteotek, Inc.·1987-01-22
K861628 — WELLCOZYME ROTAVIRUS WZ01Wellcome Diagnostics·Product code LIQ·1987-01-21
K861686 — NOVOPEN SYSTEM (INSULIN SYRINGE)Squibb-Novo, Inc.·Product code FMF·1987-01-21
K863709 — CHALLENGE ORTHODONTIC BONDING ADHESIVEOrmco Corp.·Product code DYH·1987-01-21
K864356 — AMYLASE REAGENTTrace Scientific , Ltd.·Product code CIJ·1987-01-21
K864439 — BECKMAN EPSILON(TM) PROLACTIN TEST KITBeckman Instruments, Inc.·Product code CFT·1987-01-21
K864464 — PSI AMYLASE REAGENTPointe Scientific, Inc.,·Product code JFJ·1987-01-21
K864480 — IL TEST 84668-15, FACTOR VIII CONTROL PLASMAInstrumentation Laboratory CO·Product code GGP·1987-01-21
K864541 — BT HYPODERMIC SYRINGEBaron Technologies, Inc.·Product code FMF·1987-01-21
K864581 — APPLIDYNGrandcor Medical Systems·Product code ISD·1987-01-21
K864667 — PENOX HOSPITAL BEDPenox Technologies, Inc.·Product code FNJ·1987-01-21
K864673 — UNSCENTED MENSTRUAL PADProcter & Gamble Mfg. Co.·Product code HHL·1987-01-21
K864725 — MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGESDentsply Intl.·Product code EMA·1987-01-21
K864808 — STRATO(R) PCA INFUSERStrato Medical Corp.·Product code FRN·1987-01-21
K864827 — RSVP SYSTEMS, SERIES I, BED-PATIENT MONITORTactilitics, Inc.·Product code KMI·1987-01-21
K864879 — OSI PAPOOSE BOARDOrthopedic Systems, Inc.·1987-01-21
K864882 — FERROZINE (COLORIMETRIC) IRON BINDING CAPACITYPointe Scientific, Inc.,·Product code JIY·1987-01-21
K864953 — WEIGHMOBILE, IN BED PATIENT WEIGHING SCALEDittmar and Penn Corp.·Product code FRW·1987-01-21
K865072 — ARROW XT POWERED WHEELCHAIRIvacare Corp.·Product code ITI·1987-01-21
K870017 — AMG + MED LANCETCan-Am Surgical Corp.·Product code FMK·1987-01-21
K870033 — AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460American Research Products Co.·Product code CEM·1987-01-21
K870044 — MCD SPECIALTY BRAND NEEDLE COUNTERSMedical Concepts Development, Inc.·1987-01-21
K870071 — TOSHIBA, SMIT ROENTGENNorth American Imaging, Inc.·Product code ITY·1987-01-21
K870103 — LEAD APRON CADDYOrthopedic Systems, Inc.·Product code EAJ·1987-01-21
K861267 — UROCUT BIOPSY NEEDLEMeadox Surgimed, Inc.·Product code KNW·1987-01-20
K863429 — MODIFIED DEVICE FOR SELF EXAMINATION OF EYESWheel Checkers·Product code HOQ·1987-01-20
K863686 — BACK REST, LITTER, NON-ADJUSTABLEBrenner Metal Prod Corp.·Product code FPP·1987-01-20
K863688 — ROD, IRRIGATOR, SUPPORTING TELESCOPING, TYPEBrenner Metal Prod Corp.·Product code FNJ·1987-01-20
K863691 — COT, FOLDING, HOSPITAL, ALUMINUMBrenner Metal Prod Corp.·Product code FNJ·1987-01-20
K863694 — BED/ADJUST/HOSPITAL/FOLDING FIELD WITHOUT MATTRESSBrenner Metal Prod Corp.·Product code FNJ·1987-01-20
K863886 — SPORTLIFE SUNWEARNorth American Vacuum Coating Co.·Product code HQY·1987-01-20
K864310 — RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGERymco Ltda·Product code FMI·1987-01-20
K864402 — BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBENew England Surgical Instrument Corp.·Product code GEI·1987-01-20
K864407 — REFILLABLE SYRINGEMed Fusion Systems, Inc.·Product code FMF·1987-01-20
K864440 — CHURCHILL 3-WAY STOPCOCKChurchill Corp.·Product code FMG·1987-01-20
K864441 — CHURCHILL BLOOD ADMINISTRATION SETChurchill Corp.·Product code BRZ·1987-01-20
K864453 — EMERGENCY & MILITARY INFUSION SYSTEMMigada, Ltd.·Product code FPA·1987-01-20
K864502 — THE CONTACT LENS ASSIST BRUSHYoung and Moore Enterprises, Inc.·Product code LPN·1987-01-20
K864520 — BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRONPrecision Instruments, Inc.·Product code HRH·1987-01-20
K864594 — DUALENZ LOW VISION EYEWEARGlobal Eye Care, Inc.·Product code HKK·1987-01-20
K864689 — ALBA HEALTH CARE IODOFORM PACKING STRIPAlba Health Care·1987-01-20
K864726 — I/A/KPE TIPIpax, Inc.·Product code HQC·1987-01-20
K864753 — FREE SPIRIT(TM) I.V. STANDDemstar Corp.·Product code FOX·1987-01-20
K864784 — SERAFLO(TM) BLOODLINES FOR HEMODIALYSISCd Medical, Inc.·Product code FJK·1987-01-20
K864810 — LIDSPLINTPrecision Therapeutics, Inc.·Product code HMP·1987-01-20
K864899 — SURGICAL DRAPE PACKWebster Enterprises, Inc.·Product code KKX·1987-01-20
K864923 — VACU-PREPDiversified High Tech Co.·1987-01-20
K864964 — 5 - IN - 1 CONNECTORMedovations, Inc.·Product code GAZ·1987-01-20

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