FDA 510(k) clearances — page 1344

176,637 clearances on record, most recent first.

Clearances — page 1344

134,301–134,400 of 176,637

K884280 — MODEL WC-102 NEWBORN BED & EQUIPMENT CABINETGempco, Inc.·Product code FMT·1988-12-22
K884283 — MODEL WC-107 MOBILE NEWBORN BEDGempco, Inc.·Product code FMT·1988-12-22
K884285 — MODEL WC-115 MOBILE BASSINETGempco, Inc.·Product code FMT·1988-12-22
K884316 — OCCLUSAL HARMONY IMPRESSION TRAYAdvantage Dental Co.·Product code EHY·1988-12-22
K884349 — ADAC VIEWPOINT (ADDITIONAL SOFTWARE)Adac Laboratories·Product code KPS·1988-12-22
K884352 — SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CUREDScientific Pharmaceuticals, Inc.·Product code EBF·1988-12-22
K884403 — LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBESupelco, Inc.·Product code DPM·1988-12-22
K884498 — COTUBE LH IRMA ASSAYBio-Rad·Product code CEP·1988-12-22
K884641 — BOVAC SMOKE COLLECTOROrthopedic Systems, Inc.·Product code GEI·1988-12-22
K884750 — GROUP A STREP, BETA-STREPAmpcor, Inc.·Product code GTZ·1988-12-22
K884815 — SLT CLMD CONTACT LASERSurgical Laser Technologies, Inc.·Product code LLO·1988-12-22
K884826 — GAUZE SPONGEMedical Action Industries, Inc.·Product code EFQ·1988-12-22
K884930 — COMPAX MODEL 40, 400, 400TGeneral Electric Co.·Product code IZZ·1988-12-22
K885042 — SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MDSony Medical Electronics Co.·Product code KQM·1988-12-22
K882484 — CMS RECORD AND VERIFY SYSTEMComputerized Medical Systems, Inc.·Product code JAD·1988-12-21
K883354 — VARIABLE KV INTREX VSK 60 - 90 KVPKeystone X-Ray, Inc.·Product code EAP·1988-12-21
K884104 — USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATORC.R. Bard, Inc.·Product code DYB·1988-12-21
K884129 — BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SETBio Medicus, Inc.·Product code DQY·1988-12-21
K884209 — USCI DORROS INFUSION/PROBING CATHETERUsci, Div. C.R. Bard, Inc.·Product code DQY·1988-12-21
K884262 — ACS(R) HI-TORQUE GOLD(TM) GUIDE WIREAdvanced Cardiovascular Systems, Inc.·Product code DQX·1988-12-21
K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTERMedtronic Blood Systems, Inc.·Product code KRJ·1988-12-21
K884607 — MT/S (SOFTWARE RELEASE 3.1)Diasonics, Inc.·Product code LNH·1988-12-21
K880586 — AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2C.I.S.A. Import Export C/O Larson and Taylor·Product code HIB·1988-12-20
K880587 — AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3C.I.S.A. Import Export C/O Larson and Taylor·Product code HIB·1988-12-20
K880588 — AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4C.I.S.A. Import Export C/O Larson and Taylor·Product code HIB·1988-12-20
K882686 — ERYTHROPOIETIN ENZYME IMMUNOASSAYAmgen, Inc.·Product code GGT·1988-12-20
K883709 — MODIFICATION OF MONO-PLUS(TM)Armkel, LLC·Product code KTN·1988-12-20
K884016 — DC-1 I.V. DOSAGE COMPUTERPhase Medical, Inc.·Product code NDC·1988-12-20
K884089 — ERA 2000 EMERGENCY RESUSCITATORNeotronics Medical , Ltd.·Product code BTL·1988-12-20
K884144 — TURBOX ANTITHROMBIN IIIUnipath , Ltd.·Product code JBQ·1988-12-20
K884179 — TURBOX FIBRINOGENUnipath , Ltd.·Product code KQJ·1988-12-20
K884268 — VOXELSCOPE(TM)Dynamic Digital Displays, Inc.·Product code JAK·1988-12-20
K884305 — KOTEX STICK TAMPONS, REGULAR AND SUPERKimberly-Clark Corp.·Product code HEB·1988-12-20
K884317 — MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEMMedrad, Inc.·Product code JAA·1988-12-20
K884359 — UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.Automatic Liquid Packaging, Inc.·Product code CAF·1988-12-20
K884446 — MAXITHINS SUPER PADS, DEODORANTTambrands, Inc.·Product code HHL·1988-12-20
K884684 — ROCKET INTRAUTERINE DEPTH SOUNDA & A Medical, Inc.·Product code HHM·1988-12-20
K884985 — MODIFIED 10CC SYRINGE CONTROL RING SETProcedure Products, Inc.·Product code FMF·1988-12-20
K885001 — QM300 PCR ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.·Product code DCN·1988-12-20
K883488 — CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL.Heraeus Lasersonics, Inc.·Product code GEX·1988-12-19
K883530 — FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TESTTambrands, Inc.·Product code CEP·1988-12-19
K883764 — INTRAVASCULAR ADMINISTRATION SETDevice Labs, Inc.·Product code FPA·1988-12-19
K883886 — DOUBLE CLOSED URINARY DRAINAGE SYSTEMKnight Medical, Inc.·Product code FCN·1988-12-19
K883993 — MODIFIED IMED GEMINI PC-1 INFUSION PUMPImed Corp.·Product code FRN·1988-12-19
K884003 — GONIOMETER AND BIOMEDICAL RECORDER SYSTEMPenny & Giles Blackwood , Ltd.·Product code KQX·1988-12-19
K884113 — HEARING AID WIDEX BTEWidex Hearing Aid Co., Inc.·Product code ESD·1988-12-19
K884459 — LUXAR ENDOGUIDE CO2 LASER WAVEGUIDELuxar Corp.·Product code GEX·1988-12-19
K884734 — CREATININE TEST (CREA) ITEM #65663Em Diagnostic Systems, Inc.·Product code CGX·1988-12-19
K880932 — MRL PACETTE, 450SLLMedical Research Laboratories, Inc.·Product code DRO·1988-12-16
K881483 — AIRWAY-CIRCULATION EVALUATORResuscitation Ace, Inc.·Product code BTM·1988-12-16
K883105 — EZ-SCREEN CANNABINOID/COCAINEEnvironmental Diagnostics, Inc.·Product code DIO·1988-12-16
K883188 — T.E.N.S. UNIT SIGMA & TX-3Diamond Medical Equipment, Inc.·Product code GZJ·1988-12-16
K883543 — HDL-CHOLESTEROL PRECIPITATING REAGENTMedical Analysis Systems, Inc.·Product code CHH·1988-12-16
K883557 — NEUROWAVE SYSTEM 2Durden Enterprises, Inc.·Product code GWQ·1988-12-16
K883606 — MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANSHewlett-Packard Co.·Product code LKD·1988-12-16
K883615 — LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73Supelco, Inc.·Product code DJY·1988-12-16
K883919 — NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZERNaparima, Inc.·Product code DSB·1988-12-16
K884051 — DSM-1 DOSIMETERS & M Instrument Co.·Product code CAF·1988-12-16
K884063 — BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEMC.R. Bard, Inc.·Product code CCE·1988-12-16
K884098 — THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101American Biosystems, Inc.·Product code BYI·1988-12-16
K884142 — OXINET N-7500 PULSE OXIMETRY NETWORKNellcor, Inc.·Product code DXH·1988-12-16
K884329 — SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTERBaxter Healthcare Corp·Product code DQA·1988-12-16
K884355 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE)Eastman Kodak Company·Product code JIY·1988-12-16
K884525 — PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORTIntertech/Ohio·Product code BZO·1988-12-16
K884735 — PHOSPHORUS TEST (PHOS) ITEM #65666Em Diagnostic Systems, Inc.·Product code CEO·1988-12-16
K884968 — TDX METHADONE ASSAYAbbott Laboratories·Product code DJR·1988-12-16
K885006 — CHLAMYDIAZYME/COMMANDER INSTRUMENTATIONAbbott Laboratories·Product code LJC·1988-12-16
K882440 — EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TESTZeus Scientific, Inc.·Product code LLM·1988-12-15
K882447 — EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TESZeus Scientific, Inc.·Product code LSE·1988-12-15
K883334 — BIODOP(TM)Diagnosis Related Systems, Inc.·Product code HEK·1988-12-15
K883533 — ABC FP ANALYZERIntl. Bioclinical, Inc.·Product code JJE·1988-12-15
K883726 — THYROID STIMULATING HORMONE (HTSH) IRMA NEONATALImmuchem Corp.·Product code JLW·1988-12-15
K883925 — UROIMAGERAusonics Pty , Ltd.·Product code IYO·1988-12-15
K884152 — CENTURY COLOR TRACEBiomedical Systems, Inc.·Product code DSI·1988-12-15
K884224 — TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.·Product code CIG·1988-12-15
K884278 — IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436Telectronics, Inc.·Product code DTB·1988-12-15
K884348 — MODIFIED JELTRODE(TM) ELECTRODES DEEMEDHenley Intl.·Product code GXY·1988-12-15
K884424 — LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)Bio-Rad·Product code JJW·1988-12-15
K884693 — UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDSBiomedical Research & Development Laboratories, Inc.·Product code JIX·1988-12-15
K884749 — JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGEJohnson & Johnson Patient Care, Inc.·Product code KYZ·1988-12-15
K884838 — ALLEN PRONE ARMBOARDEdgewater Medical Systems, Inc.·Product code BTX·1988-12-15
K884876 — S 4 INSTRUMENT STANDCarl Zeiss, Inc.·Product code FSH·1988-12-15
K884928 — FREE ARM(TM)Faro Medical Technologies, Inc.·Product code FWZ·1988-12-15
K884929 — OCCUSHIELDSDioptics·Product code FXX·1988-12-15
K884994 — SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIPSharplan Lasers, Inc.·Product code GEX·1988-12-15
K882679 — SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATIONSurgical Laser Technologies, Inc.·Product code HQB·1988-12-14
K882731 — TAB PAKDynex Trading Co.·Product code NXB·1988-12-14
K883079 — WWDS-005 HUMAN RECTAL PROBEAusonics Pty , Ltd.·Product code IYO·1988-12-14
K883389 — RAICHEM(TM) BILIRUBIN CONJUGATE STANDARDReagents Applications, Inc.·Product code JIW·1988-12-14
K883559 — DELFIA THYROXINE (T4) KITPharmacia, Inc.·Product code CDX·1988-12-14
K884111 — PUMPETTE(TM)Helena Laboratories·Product code JKA·1988-12-14
K884197 — DOCUMENT(TM) CHOLESTEROL CALIBRATOR SETCasco Standards·Product code JIT·1988-12-14
K884201 — FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.·Product code CEE·1988-12-14
K884258 — VERSABLOTAmerican Bionetics, Inc.·Product code KPA·1988-12-14
K884377 — ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654Em Diagnostic Systems, Inc.·Product code CIT·1988-12-14
K884649 — TOTAL IRON BINDING CAPACITY TESTSclavo, Inc.·Product code JQE·1988-12-14
K881841 — DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELSBuckman Co., Inc.·Product code DSB·1988-12-13
K882657 — HARBOR S.E.A.-PORT SURGICAL ACCESSORY KITHarbor Medical Devices, Inc.·Product code DYB·1988-12-13
K883487 — LYME DISEASE IFA (IGG)Hillcrest Biologicals·Product code LSR·1988-12-13
K883506 — IRRIGATION KITL H M Ent., Inc.·Product code KYZ·1988-12-13

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