FDA 510(k) clearances — page 1368
clearances on record, most recent first.
Clearances — page 1368
136,701–136,800 of 175,890- K880142 — TSA W/LEC. & TWEEN. 80
- K880165 — TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
- K880477 — RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
- K880729 — KALLESTAD QM300 CALIBRATOR C PACK
- K880945 — CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597
- K880962 — ATS CRYPTOSPORIDIUM STAIN CONTROL SLIDES
- K881042 — ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)
- K881107 — INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES
- K881111 — INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL
- K874724 — SARA AGIE MONITOR
- K875174 — RATEMINDER V INFUSION PUMP
- K875183 — LC OXYGEN ANALYZER
- K875264 — WASHING CATHETER
- K880072 — PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM
- K880597 — THUMPER MODEL P-1000
- K880704 — CERULLO SUCTION REGULATOR
- K880803 — WAKO(TM) IGA-HA DIRECT
- K874894 — TECNOL LASER SURGICAL MASK
- K875322 — MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER
- K875323 — MODIFIED SCHNEIDER-SHILEY WIRE TORQUER
- K875367 — COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV
- K880044 — OECO MEMBRANE OXYGNE & VAPOR ENRICHER MODEL OE-8
- K880154 — METATECH INTRACRANIAL PRESSURE MONITORING SYSTEM
- K880532 — SINGLE PHASE DIAGNOSTIC X-RAY GENERATOR FX 350
- K880822 — PICS-2000
- K880965 — SOMATOM PLUS
- K881082 — GV 11 (TM), MODEL 9700
- K881150 — KINETIC FIBRINOGEN ASSAY
- K881222 — JOHNSON & JOHNSON FLUFF SPONGE
- K871932 — MODEL 5050 SURGILASER FOR UROLOGY USE
- K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE
- K873410 — DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE
- K874136 — PHOTIC STIMULATOR MODELS 580-PSCOMP,PSCEEG,PSSTAL
- K875324 — MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES
- K875327 — MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT
- K880074 — RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS
- K880414 — TENDON HARVESTER
- K880547 — VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY
- K880718 — CALCOFLUOR WHITE STAIN KIT
- K880728 — KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK
- K880730 — KALLESTAD QM2/QM300 CONTROL C PACK
- K880736 — NOVA LITE(TM) ANA
- K880742 — NOVA LITE(TM) DSDNA
- K880828 — WAKO(TM) IGM-HA DIRECT
- K880896 — NOVA GEL(TM) SS-A/SS-B
- K881020 — SURGICAL SEALANT DISPENSER (SSD)
- K881060 — OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION)
- K881084 — UTILITY CLAMP
- K872998 — VITAACCESS (TM) CATHETER INTRODUCER SYSTEM
- K873820 — MOBAY (BAYER) MAKROLON 2658 1112
- K873821 — GE NORYL 731-80089S
- K873822 — MOBAY (BAYER) MERLON M-40 (H)F 1112
- K873823 — MOBAY (BAYER) MAKROLON 2658 3291
- K873824 — RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000
- K873825 — GE LEXAN 144R 112
- K873834 — INET MODEL BIOVISION
- K873992 — LARYNGECTOMY TUBE
- K874829 — MEDCO MEMORY RETRACTOR SYSTEM
- K874875 — CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)
- K874887 — WESBLOT PROCESSOR
- K875334 — KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
- K875350 — OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
- K875371 — KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM
- K880006 — STA-SET I.V. FLOW REGULATOR
- K880043 — EBV-NA TEST
- K880070 — ABBOTT IMX HCG
- K880170 — MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
- K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
- K880291 — THEOPHYLLINE TEST KIT REF. #A874799
- K880296 — LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY
- K880312 — WAKO(TM) AUTOKIT TOTAL PROTEIN
- K880313 — WAKO(TM) AUTOKIT ALBUMIN
- K880452 — LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE
- K880467 — STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR
- K880497 — WORD BARTHOLIN GLAND CATHETER CODE: 1005
- K880546 — TOTAL IRON BINDING CAPACITY (TIBC)
- K880606 — UTILITY WAX STRIPS, CINNAMON
- K880610 — UNIMETER CALIBRATION KIT
- K880620 — EMIT THYROXINE ASSAY
- K880651 — PARAMAX AMMONIA REAGENT
- K880676 — INORGANIC PHOSPHORUS REAGENT SET
- K880677 — TOTAL PROTEIN REAGENT SET
- K880687 — CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
- K880701 — QUANTIMETRIX SERUM ENZYME CONTROL
- K880710 — PROTEIN BASE ISE CONTROL
- K880731 — WAKO AUTOKIT URIC ACID
- K880990 — ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION
- K880999 — EPIPACK
- K881067 — NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK
- K881115 — BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA
- K872113 — OMNI-VENT, SERIES D
- K873937 — SDR 3500 (PHILIPS PLATINUM +)
- K874680 — LASEGUIDE 600A, 600B, 400A, AND 400B
- K875328 — IVT WESTERN ALLERGY SCREEN
- K875368 — THE DDI SERODOT RUBELLA IGG TEST KIT
- K880264 — BONE SUTURE FIXATION DEVICE
- K880330 — FERRIS HYDROPHILIC DRESSING
- K880566 — CLP PROTHROMBIN TIME TEST
- K880598 — MODIFICATIONS TO API UNISCEPT (R) KB
- K880629 — CREATININE
Data sourced from openFDA. This site is unofficial and independent of the FDA.