FDA 510(k) clearances — page 977
clearances on record, most recent first.
Clearances — page 977
97,601–97,700 of 175,890- K963116 — UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY
- K951113 — CROSS-CHECKS
- K960861 — OMICRON MONITOR, DELTA MONITOR
- K960962 — INTERFERENCE SCREW
- K961374 — PHILIPS MULTIDIAGNOST 4
- K961573 — TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
- K961764 — PR-3 ELISA TEST SYSTEM
- K961765 — MPO ELISA TEST SYSTEM
- K961829 — QUALITROL CRP CONTROL SET
- K962069 — MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES
- K962101 — ZWEYMUELLER SL FEMORAL HIP STEM
- K962186 — N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
- K962227 — PRO-FECT STERILE GAUZE SPONGES
- K962261 — IMPLANTECH WM NASAL-LABIAL IMPLANT
- K962353 — ACCUSIGN DOA 5 (THC/OPI/COC/MET OR AMP/PCP)
- K962372 — UROTAC BONE ANCHOR INSERTER
- K962699 — RADWORKS MEDICAL IMAGING SOFTWARE
- K962808 — ILIZAROV EXTERNAL FIXATION SYSTEM
- K954575 — AXSYM TOXO IGG ANTIBODY ASSAY
- K955107 — SAFESTRIP
- K955546 — PATIENT MONITOR MODEL 405P
- K960437 — RADIAS PHENYLALANINE TEST
- K960790 — PROSPORE II
- K961281 — TRIGLYCERIDE-SL ASSAY CATALOGUE NO. 236-60
- K961357 — PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE
- K961837 — RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
- K961896 — MICROLAB 4000, MICROLAB 4200
- K961976 — THE BIOPLATE FIXATION SYSTEM
- K962150 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K962280 — ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
- K962762 — SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
- K962809 — SEIRIN ACUPUNCTURE NEEDLES
- K963002 — ACTIVE ANDROSTENEDIONE EIA
- K951033 — ANDELA DYNAMIC COOLING DEVICE
- K954736 — ACCESS (POWERCLAVE)
- K954995 — QUIX RAPID CHOLERA STRIP TEST
- K955113 — DINAMAP SELECT MULTI-PARAMETER SYSTEM
- K955507 — GRAYCO POCKET PUMP
- K960584 — NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY
- K960841 — POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM
- K960940 — BIOSCREW ABSORBABLE INTERFERENCE SCREW
- K961365 — ENDOCARE ELECTORNIC THERMOMETER SYSTEM
- K961682 — ARGON CURING LASER
- K961912 — QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET
- K961915 — SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE
- K961923 — BERENSTEIN COIL
- K961936 — MODEL 2188 CORONARY SINUS LEAD.
- K961973 — DHD ACE WITH MASK KIT
- K962023 — PLASTIC PROTECTION HEALING CAPS
- K962161 — BAXTER NEBULIZER CAP MODEL 2D0868
- K962215 — CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
- K962240 — MOORE TRACHEOSTOMY TUBE
- K962247 — HICHEM CK/NAC REAGENT KIT
- K962344 — MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
- K962508 — ELECSYS T3
- K962594 — ACA PLUS FT4 CALIBRATOR
- K962602 — ACA PLUS FREE THYROXINE(FT4) METHOD
- K962650 — PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE)
- K962669 — ACCUSIGN BAR-RAPID ONE-STEP BARBITURATE ASSAY
- K962673 — ACCUSIGN MTD-RAPID ONE-STEP METHADONE ASSAY
- K962841 — OPUS MYOGLOBIN CONTROLS
- K962997 — NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
- K955719 — SICKLE-2000
- K955931 — MODEL IM77 INTRAPARTUM FETAL MONITOR (MODIFICATION)
- K960474 — COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
- K960656 — GORE BURR HOLE COVER
- K960871 — SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
- K961893 — DURAFLOR
- K961894 — MDI TUTOR
- K961914 — BACTERIA/VIRAL FILTER
- K962048 — 1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)
- K962152 — OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
- K962162 — DALL-MILES TROCHANTER CABLE SUPERGRIP
- K962287 — EAGLE EYES SUNGLASSES
- K962461 — NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES
- K962463 — PROCAINAMIDE ENZYME IMMUNOASSAY
- K962670 — NHMC IRRIGATION TRAY
- K962678 — BIPOLAR PENCIL COAGULATOR
- K962789 — SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
- K952614 — JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
- K953946 — MICROSELECTRON-HDR VERSION 2
- K954205 — THE AMPLATZ THROMBECTOMY DEVICE
- K961814 — THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS
- K961867 — PEEP VALVE
- K961927 — RMI HEMOCONCENTRACTOR TUBING SET
- K961939 — S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115)
- K961983 — TRS 2000 TELERADIOLOGY SYSTEM
- K962082 — OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT
- K962476 — UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
- K952050 — GLOVE, EXAMINATION, VINYL
- K952163 — DAVID BACK CLINIC SYSTEM
- K954789 — BRAINLAB HEADPINS
- K955742 — D. DEVICE II
- K960445 — INPUT TUOHY-BORST LOCKING DEVICE
- K960686 — HYCOAT
- K960749 — HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
- K960843 — STOP-N-GROW
- K961869 — DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
- K962005 — EXTRAHAND BALLOON RETRACTOR
- K962785 — 3M DENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.