FDA 510(k) clearances — page 1400
clearances on record, most recent first.
Clearances — page 1400
139,901–140,000 of 175,890- K871809 — FLEXIBLE BIOPSY FORCEP
- K872078 — QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL
- K872127 — D-SCOPE II AND D-SCOPE IIC
- K862121 — E.W.L. P-TENS/H-WAVE
- K870731 — LYFO KWIK(TM) RUS KIT
- K871254 — ACCULEVEL CARBAMAZEPINE TEST
- K871303 — DELFIA(TM) THYROXINE (T4) KIT
- K871449 — ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG
- K871497 — LINER OR GSRI-PNF
- K871546 — SAFESIDE(TM) LUMED
- K871589 — THEOPHYLLINE FPIA CONTROLS
- K871620 — ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT
- K871708 — NEO-I TEMPERATURE & CONDUCTIVITY METER
- K871749 — ADULT PERM-CATH 40CM.
- K871777 — VAN-TEC REUSABLE HELICAL STONE BASKET
- K871779 — HELICAL STONE BASKET (DISPOSABLE)
- K871788 — LIQUID TDM CONTROLS
- K871831 — PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT
- K871888 — DIGITAL FEVER THERMOMETER MODEL MC-5
- K871892 — TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER
- K871942 — PERM-CATH CATHETER KIT
- K871981 — BILATERAL CONTINUOUS PASSIVE MOTION DEVICE
- K872015 — SPIRASEAL(TM) FACE MASK (VARIOUS SIZES)
- K872029 — UNI-FAST CREATINE KINASE TEST (CK)
- K872103 — KODAK EKTACHEM 700S ANALYZER
- K872104 — KODAK EKTACHEM 700P ANALYZER
- K872108 — ABBOTT SPECTRUM BICARBONATE REAGENT KIT
- K872122 — 8000 SERIES GAS CHROMATOGRAPHS
- K872177 — TIPSEP-CORTISOL RIA DIAGNOSTIC KIT
- K864614 — LP-3 ELECTROCARDIOGRAPH
- K870375 — MODEL 617 CARDIAC OUTPUT COMPUTER
- K870515 — DYNATRON 438
- K871021 — GUIDING CATHETERS 9F JL4
- K871166 — ALLEVYN HYDROPHILIC POLYURETHANE DRESSING
- K871549 — RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125]
- K871900 — OVER DRAPE LEG HOLDER
- K871916 — FRASTEC DRY BURN DRESSING
- K871917 — FRASTEC DRY GAUZE BANDAGE
- K870330 — SP55 SYRINGE PUMP
- K870719 — SENSIR SYSTEM
- K871085 — EXTENSION TUBE PUMP SET
- K871086 — IV PUMP SET
- K871253 — MASSTRON/MARQUEST MT-1000 GAS ANALYZER
- K871263 — MULTIPLE PHARMA-PLAST TRACHEAL TUBE
- K871407 — MECONIUM ASPIRATOR
- K871596 — IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)
- K871661 — WH150 ROOM HUMIDIFIER
- K871673 — NASOPHARYNGEAL AIRWAY
- K871698 — RESUBMISSION OF URINE HEROIN/MORPHINE KIT [I-125]
- K871732 — CHURCHILL-H VENTED IV SET W/METERING CHAMBERS
- K871742 — MODIFIED USE OF PLEX INSPIRATORY MUSCLE TRAINER
- K871829 — SIEMENS DRY AIR COMPRESSOR
- K871895 — TINA-QUANT [A] CRP
- K871896 — TINA-QUANT [A] TRANSFERRIN
- K871949 — MMG DELEE SUCTION CATHETER W/MUCOUS TRAP
- K871985 — BEAR JET VENTILATOR FOR USE DURING (ESWL)
- K872001 — MODEL TPC-1A OXYGEN ANALYZER
- K872056 — MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST
- K872076 — CORNING DISPOSABLE ROLLER BOTTLES
- K872079 — RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS
- K872080 — RAICHEM(TM) SPIA(TM) APO B REAGENTS
- K872081 — CIPRO (TM) DIAGNOSTIC POWDER
- K872086 — ACUSYST-JR
- K872135 — MCBRIDE MEDIUM CM 819
- K872140 — (MSI) PATH-SAVER
- K863702 — PULSE CUFF RECORDER MODEL PCR100
- K870356 — TATCH-IT
- K870840 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH
- K871077 — MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.
- K871152 — SIGMA'S CALCIUM PROCEDURE NO. 587
- K871348 — SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE
- K871371 — DIGITAL SPHYGMOMANOMETER
- K871471 — CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
- K871487 — VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH
- K871488 — VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH
- K871489 — DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM
- K871599 — DELFIA(TM) HIGE KIT
- K871604 — MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
- K871685 — HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
- K871890 — CARDIO-MEGA SYSTEM
- K871939 — QM300 C3 ANTIBODY PACK
- K871940 — QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
- K872062 — EYEDENTITY EYEWEAR
- K872128 — K-GEL
- K863393 — ENDOCATER
- K870414 — QUIK-BRUSH
- K871174 — 4-9295 BARBITURATES TEST MIX
- K871304 — LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9
- K871308 — ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT
- K871396 — ACCULATOR 287EP
- K871409 — VINYL POLYSILOXANE IMPRESSION SYSTEM
- K871423 — PHENYTOIN FPIA CALIBRATORS
- K871602 — MICROCHECK LH OVULATION TEST
- K871645 — TDXR REA(TM) ETHANOL
- K871716 — ULTRA MAXITHINS PADS
- K871800 — SUMMIT OPTICS POST-MYDRIATIC SPECTACLES
- K871871 — SERIES TEN THOUSAND OCUTOME
- K871973 — IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS.
- K871979 — GAMMA GLUTAMYLTRANSFERASE REAGENT
- K872010 — MULTICHEM LDH-L REAGENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.