FDA 510(k) clearances — page 983
clearances on record, most recent first.
Clearances — page 983
98,201–98,300 of 176,637- K960857 — GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR
- K960858 — GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
- K961697 — OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
- K962020 — S-41 & S-41S VIDEO IMAGING SYSTEM
- K962044 — VALLEYLAB COATED ELECTRODES
- K962231 — COBAS CORE IMMUNOCHEMISTRY SYSTEM
- K962272 — SYNTHES MANDIBLE DISTRACTOR
- K962549 — VIDAS CREATINE KINASE MB ASSAY 30-421
- K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD
- K962672 — ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
- K962758 — DSL 9100 IGF-II IRMA
- K962794 — ETEST FOR AZTREONAM
- K962885 — SEALEX EXTRA ROOT CANAL SEALER
- K963165 — ELECSYS CALCHECK HCG
- K935512 — CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE
- K955672 — TROJAN POLYURETHANE CONDOM (MODIFICATION)
- K960003 — STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION
- K960263 — CERVICAL MUCOUS ASPIRATION CATHETER
- K960549 — MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE
- K961702 — KSEA VAPORIZATION ELECTRODES
- K961860 — A4907 LENS CLEANING SHEATH
- K962097 — VENTRICULAR CATHETER SET
- K962106 — SPLINE DENTAL IMPLANT SYSTEMS
- K962115 — CAMBRIDGE HEART HI-RES ECG ELECTRODE
- K962135 — D.O.R.C. MICRODIATHERMY SYSTEM
- K962248 — P.F.C. CERAMIC HIP HEAD
- K962259 — LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
- K962289 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT
- K962306 — FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES
- K962311 — FRESHFROZENCELLS
- K962371 — DERMTOME BLADE
- K962405 — SANICURE DISPOSABLE CURING PROBE
- K962580 — EZ SURE ONESTEP EARLY PREGNANCY TEST
- K962780 — FRESHCELLS, HEP-2
- K962782 — FRESHFROZEN CELLS, HEP-2
- K962975 — PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)
- K963240 — IMMULITE ACTH CONTROL MODULE (LACCM)
- K951128 — MEDILOG STRESSLINK
- K954623 — REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
- K960700 — LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM
- K960933 — BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
- K960971 — OCULIGHT GL
- K962156 — 3304 PULSE OXIMETER
- K962193 — PORTLAND TROCARS
- K962224 — SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
- K962228 — MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
- K962553 — EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM
- K962581 — STOPCOCK MANIFOLD GANGS
- K962801 — SAFE MATE I.V. EXTENSION SETS
- K962802 — SAFE MATE I.V. FLUID DELIVERY SETS
- K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
- K955880 — DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05
- K960205 — CPR TRACHEOTOMY CARE TRAY
- K960356 — POSTERIOR ANNULOPLASTY BAND (MODEL 607)
- K960435 — PHOENIX CRX VALVE
- K961587 — IRON (TOTAL) ASSAY CATALOGUE NO. 102-10, 102-25
- K961718 — DEI MODEL 20 EEG
- K962099 — CEDIA PROCAINAMIDE ASSAY
- K962117 — QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
- K962154 — CARBOMEDICS HANDLE
- K962396 — KSEA BIPOLAR GOAGULATING FORCEPS
- K962397 — STATAK SOFT TISSUE ATTACHMENT DEVICE
- K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
- K962898 — KSEA UNIMAT PLUS
- K962934 — AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WEAR
- K963163 — ELECSYS CALCHECK FT3
- K963164 — ELECSYS CALCHECK FT4
- K963167 — ELECYS CALCHECK T 3
- K963178 — ELECSYS CALCHECK T4
- K960424 — BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD
- K960767 — LIGHT COMMANDER
- K961250 — DYNATRON 125 ULTRASOUND
- K962085 — SALTER LABS 8990 SERIES NEBULIZER
- K962121 — HORIZON/WESTHIN 55-G
- K962279 — ACRYLIC READING AND POLYCARBONATE LENSES SUNGLASSES
- K962940 — RAVEN EYE, INC.- EYE WEAR
- K963083 — LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES
- K963284 — RAVEN EYE- EYE WEAR (SUNGLASSES)
- K954576 — AXSYM TOXO IGM
- K954594 — RETICULOCYTE METHOD, RBC INDICES
- K960826 — CADD-PRIZM MODEL 6100 PUMP
- K961083 — OREX SURGEON'S VEST
- K961103 — BENZ 38 CLEAR & WITH BLUE VISIBILITY TINT
- K961263 — MODEL 1200 ABMULATORY INFUSION PUMP
- K961311 — HEMOCUE B-GLUCOSE SYSTEM
- K961699 — EQUIPMENT COVERS
- K961721 — STERITEC DISPOSABLE BIOLOGICAL TEST PACK
- K962051 — ASPECT OPTICAM
- K962076 — MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6)
- K962080 — RPS-50 BEAM SCANNER
- K962094 — MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES
- K962095 — MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES
- K962131 — STORZ D4600 AIR EXCHANGE LINE PACK
- K962196 — NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS
- K962779 — COMPRESSION SCREW
- K962866 — OPUS HLH
- K962875 — ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
- K962906 — SCRIPPS LABORATORIES HCG ONE-STEP
- K962916 — HUA-XIA ACUPUNCTURE NEEDLES
- K962982 — NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
Data sourced from openFDA. This site is unofficial and independent of the FDA.