FDA 510(k) clearances — page 884

176,637 clearances on record, most recent first.

Clearances — page 884

88,301–88,400 of 176,637

K984609 — ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES IIILite Specialty Metal Works, Inc.·Product code EIA·1999-02-09
K984610 — POWDER FREE NITRILE EXAMINATION GLOVESShiva Medicare , Ltd.·Product code LZA·1999-02-09
K984638 — PARAGON BOLUS ACCESSORY SETI-Flow Corp.·Product code FPA·1999-02-09
K990027 — OMNICORDER, MODEL 464Del Mar Avionics·Product code DSH·1999-02-09
K990104 — MEDTRONIC MODEL 7495 EXTENSION KITMedtronic Vascular·Product code GZB·1999-02-09
K990226 — GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOWGe Medical Systems, Inc.·Product code IYO·1999-02-09
K981720 — IQ SYSTEMRenaissance Technology, Inc.·Product code DSB·1999-02-08
K983438 — MAX ITDorea, Inc.·Product code LKY·1999-02-08
K983449 — GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSORGereonics, Inc.·Product code BZQ·1999-02-08
K983584 — HUMAN SERUM ALBUMIN (HSA)Irvine Scientific Sales Co., Inc.·Product code MQL·1999-02-08
K983595 — TRANSMYOMETRIAL EMBRYO TRANSFER SETCook Ob/Gyn·Product code MQF·1999-02-08
K984087 — SYSTEM U3 FOR AMPICILLINAb Biodisk·Product code JWY·1999-02-08
K984280 — AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGEHitachi Medical Systems America, Inc.·Product code LNH·1999-02-08
K984326 — ELECYS IGE ASSAYBoehringer Mannheim Corp.·Product code JHR·1999-02-08
K984336 — QUANTA LITE GBM ELISAInova Diagnostics, Inc.·Product code MVJ·1999-02-08
K984405 — ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000Intracom Corp.·Product code LMB·1999-02-08
K984588 — PHASED ARRAY FLEXIBLE CARDIAC COILPhilips Medical Systems (Cleveland), Inc.·Product code MOS·1999-02-08
K990025 — CARESIDE AMYLASECareside, Inc.·Product code JFJ·1999-02-08
K990071 — IMAGEFUSION 2.0Radionics, Inc.·Product code MUJ·1999-02-08
K990085 — MILLENNIUM MLC -120Varian Assoc., Inc.·Product code IYE·1999-02-08
K982938 — QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153Phamatech·Product code DJR·1999-02-05
K983015 — VIRILIS PENILE PROSTHESISSpecialty Surgical Products, Inc.·Product code FTQ·1999-02-05
K983047 — ACCU-CHEK HQ SYSTEMBoehringer Mannheim Corp.·Product code LFR·1999-02-05
K983326 — OMNIFLATOR 7640 MODEL 7-640-00Northgate Technologies, Inc.·Product code HIF·1999-02-05
K983372 — BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BPSunscope Intl., Inc.·Product code DRS·1999-02-05
K983596 — INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHINGCook Ob/Gyn·Product code MQH·1999-02-05
K983626 — KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ IIAlaris Medical Systems, Inc.·Product code DXH·1999-02-05
K983692 — ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TESTThe Binding Site, Ltd.·Product code MID·1999-02-05
K983694 — ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KITThe Binding Site, Ltd.·Product code MID·1999-02-05
K983695 — ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KITThe Binding Site, Ltd.·Product code MID·1999-02-05
K983696 — ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KITThe Binding Site, Ltd.·Product code MID·1999-02-05
K984091 — CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000Trex Medical Corp.·Product code IZH·1999-02-05
K984092 — PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000Trex Medical Corp.·Product code IZH·1999-02-05
K984166 — VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3Ortho-Clinical Diagnostics, Inc.·Product code CGN·1999-02-05
K984202 — HOWMEDICA HUMERAL INTERCALARY SYSTEMHowmedica, Inc.·Product code HSD·1999-02-05
K984301 — ABBOTT ARCHITECT FOLATEAbbott Laboratories·Product code CGN·1999-02-05
K984520 — NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005Nichols Institute Diagnostics·Product code CGR·1999-02-05
K972719 — CLARICEL STERILIZATION POUCHES AND STERILIZATION REELSMedicel, S.A. DE C.V.·Product code KCT·1999-02-04
K981629 — NUTRISAFE ENTERAL FEEDING TUBESchiff & Co.·Product code FPD·1999-02-04
K981733 — DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111Medtronic Functional Diagnostics A/S·Product code FFX·1999-02-04
K982119 — DIODE LASEREsc Medical Systems , Ltd.·Product code GEX·1999-02-04
K982472 — GENICON TROCARGenicon, LC·Product code GEA·1999-02-04
K983005 — PERFUSOR COMPACTB.Braun Medical, Inc.·Product code FRN·1999-02-04
K983614 — UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)American Healthcare Products (M) Sdn Bhd·Product code LYY·1999-02-04
K984037 — CORE-IDERoydent Dental Products, Inc.·Product code EBD·1999-02-04
K984053 — BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEMMedtronic PS Medical·Product code JXG·1999-02-04
K984230 — OSTEO-MESH TM-300Osteogenics Biomedical, Inc.·Product code JEY·1999-02-04
K984349 — DORNIER MEDILAS RDornier·Product code GEX·1999-02-04
K984505 — MIRACLE MIX POWDER/LIQUIDGC America, Inc.·Product code EMA·1999-02-04
K984561 — SUBCUTANEOUS INFUSION SETS, MSR MODEL A & BMsr, Inc.·Product code FPA·1999-02-04
K984601 — CANDELA GENTLELASE II DERMATOLOGICAL LASERCandela Corp.·Product code GEX·1999-02-04
K984613 — BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTIONAlbert Browne , Ltd.·Product code JOJ·1999-02-04
K984616 — BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND DISINFECTING SOLUTIONAlbert Browne , Ltd.·Product code JOJ·1999-02-04
K990040 — CLEARFIL SE BONDKuraray Co.·Product code KLE·1999-02-04
K990197 — MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEMExactech, Inc.·Product code MEH·1999-02-04
K981949 — NUMOBAGNumotech, Inc.·Product code KPJ·1999-02-03
K982298 — OPTICOAT T4 EIA KITBiotecx Laboratories, Inc.·Product code KLI·1999-02-03
K983506 — PRESSUREWIRE SENSOR, MODEL #12001Radi Medical Systems AB·Product code DQX·1999-02-03
K983509 — INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERTSulzer Orthopedics, Inc.·Product code LPH·1999-02-03
K983925 — ENDOPATH ULTRA VERESS NEEDLEEthicon Endo-Surgery, Inc.·Product code HIF·1999-02-03
K983950 — CERALAS DIODE LASER SYSTEM (MODEL H)Ceram Optec, Inc.·Product code GEX·1999-02-03
K983983 — EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.·Product code HLX·1999-02-03
K983999 — PANORAMIC200 OPTHALMOSCOPEOptos Plc.·Product code HLI·1999-02-03
K984108 — ABBOTT ARCHITECT B12Abbott Laboratories·Product code LIG·1999-02-03
K984209 — STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PEDBiomet, Inc.·Product code HWC·1999-02-03
K990030 — ADVANCED REVISION PRODUCT LINE EXTENSIONWrightmedicaltechnologyinc·Product code JWH·1999-02-03
K990157 — MODEL TOP END TERMINATOR SS MANUAL WHEELCHAIRInvacare Corp.·Product code IOR·1999-02-03
K980631 — EMBOL-X AORTIC OCCLUSION AND CARDIOPLEGIA CANNULAEmbol-X, Inc.·Product code DXC·1999-02-02
K981725 — OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700Optovent, Inc.·Product code BZQ·1999-02-02
K982307 — WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000Wallac, Inc.·Product code JNB·1999-02-02
K982731 — MEROGEL NASAL DRESSING AND SINUS STENTXomed, Inc.·Product code EMX·1999-02-02
K983457 — OSTEOMARK NTX SERUM EIAOstex Intl., Inc.·Product code JMM·1999-02-02
K983690 — VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACKOrtho-Clinical Diagnostics, Inc.·Product code MOI·1999-02-02
K984163 — ANTI-TPO EIA DIAGNOSTIC TEST KITThe Binding Site, Ltd.·Product code JZO·1999-02-02
K984165 — ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KITThe Binding Site, Ltd.·Product code JZO·1999-02-02
K984186 — NICHOLS ADVANTAGE CHEMILUMINESCENCE FERRITIN IMMUNOASSAYNichols Institute Diagnostics·Product code DBF·1999-02-02
K984224 — PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMSSiemens Corp.·Product code LNH·1999-02-02
K984228 — IS ANTI-TPO IGG ELISA TEST SYSTEMColumbia Bioscience, Inc.·Product code JZO·1999-02-02
K984263 — EWC: ECG II CABLE LEADWIRE SYSTEMEwc·Product code DSA·1999-02-02
K984406 — XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEMXitec, Inc.·Product code OXO·1999-02-02
K984419 — ELECSYS IGE CALCHECKBoehringer Mannheim Corp.·Product code JJY·1999-02-02
K984437 — QUANTEX ASO-CRP-RP CONTROL IIInstrumentation Laboratory CO·Product code JJT·1999-02-02
K984594 — LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220Bio-Rad·Product code JJY·1999-02-02
K984604 — ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05Bio-Rad·Product code JJX·1999-02-02
K984625 — ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05Bio-Rad·Product code JJX·1999-02-02
K990055 — B-400 CEILING MOUNTED POSSITIONER, MODEL B-400Omega Medical Imaging, Inc.·Product code JAA·1999-02-02
K990213 — HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SETGyrus Ent LLC·Product code EOB·1999-02-02
K990266 — MICROMEDICAL 12 LEAD SIMULTANEOUS CABLEMicromedical Industries, Ltd.·Product code LOS·1999-02-02
K982317 — VECTRA COMBOChattanooga Group, Inc.·Product code IMG·1999-02-01
K982321 — VECTRA STIM MODELS 200 AND 400Chattanooga Group, Inc.·Product code GZJ·1999-02-01
K982324 — VECTRA PRO MODELS 2 AND 4Chattanooga Group, Inc.·Product code GZJ·1999-02-01
K982385 — POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTERPorous Media Corp.·Product code KRJ·1999-02-01
K982559 — GUIDEWIREGalt Medical Corp.·Product code DQX·1999-02-01
K982750 — CORSAIREOptiway, Inc.·Product code ITI·1999-02-01
K982751 — IMPLEX SCREW AND WASHER SYSTEMImplex Corp.·Product code MBI·1999-02-01
K983642 — COOK MINI-INCUBATORCook Ob/Gyn·Product code MQG·1999-02-01
K983897 — CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208GRi Mos. S.R.L.·Product code HEE·1999-02-01
K983901 — KSEA HF-SNAREKARL STORZ Endoscopy-America, Inc.·Product code HIH·1999-02-01
K984084 — BARDEX LUBRI-SIL FOLEY CATHETERBard Medical Div.·Product code EZL·1999-02-01
K984124 — AESCULAP XENON LIGHT SOURCEAesculap, Inc.·Product code FSS·1999-02-01

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