FDA 510(k) clearances — page 1280
clearances on record, most recent first.
Clearances — page 1280
127,901–128,000 of 176,637- K893203 — BONE SCREW
- K893802 — PROVIEW SELF-SEALING STERILIZATION POUCH
- K894087 — SURGEON'S GLOVES
- K895462 — OSSEODENT DENTAL ATTACHMENTS
- K895801 — MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM
- K895806 — ELATEC HOLTER ANALYZER
- K895820 — RESUSO MASK
- K895889 — SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
- K896622 — VISITEC VITRECTOMY UNIT
- K896898 — BOWEN ELECTRODE SKIN PREPATORY CLEANSER
- K897093 — INTRAOCULAR MICROSCISSORS BY MEANS OF GAMMA RADIA.
- K897155 — MITEK ANCHOR(TM)
- K900091 — MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR
- K900123 — AUTO SUTURE SURGIPORT SPIRAL SLEEVE
- K900346 — SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY
- K900631 — SALIVA ABSORBER - DENTAL
- K900789 — HEARING AID (ALL-IN-THE-EAR)
- K900849 — CARDISUNY, 501BX
- K900861 — DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT
- K900866 — OXIMAX 700
- K900871 — ALTERNATING PRESSURE PUMP AND PAD SYSTEM
- K900913 — ADLER DISPOSABLE BIPOLAR CORD
- K901019 — DIACAM GAMMA CAMERA SYSTEM
- K901032 — PCI MODEL 2041-PC TELEMETRY MONITOR W/ARRHYTHMIA
- K901152 — REDYPLATE DISPOSABLE LEG PLATE
- K890486 — MXR-14 FILM PROCESSOR
- K895818 — STEADFAST DENTURE ADHESIVE CREAM
- K896300 — LDW SPIROMETRY SYSTEM
- K896631 — EXEC-WASH SOLID PHASE WASHING SYSTEM
- K897147 — SIGMA PROCEDURE NO. 735
- K900010 — NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR
- K900068 — ARISTEE (RESIN, CROWN AND BRIDGES)
- K900089 — FG DIAMOND BURRS
- K900202 — SNAP MYCOBACTERIA AVIUM COMPLEX
- K900204 — AVI MODEL 840 DUAL CHANNEL INFUSION PUMP
- K900230 — COULTER AMYLASE REAGENT
- K900231 — COULTER CALCIUM REAGENT
- K900292 — SNAP M. TUBERCULOSIS COMPLEX
- K900672 — PREBYPASS FILTER, CAT. NO. FPB-5
- K900673 — SERIAL FLOW
- K900676 — CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT
- K900700 — SMU 611 UNIVERSALMONITOR
- K900776 — NOVAPATH MICROPLATE READER
- K900779 — ENZYMUN TEST(R) LH
- K900905 — TECHNICON AXON SYSTEM REAGENT METHODS
- K901057 — SPIROMETRICS MODEL 2600 MIRO SPIROMETER
- K901135 — ENZYMUN TEST(R) INSULIN
- K901248 — ABC HANDPIECE ADAPTER
- K901296 — CEDIA (TM) CORTISOL ASSAY
- K901359 — VITAL SURGICAL GLOVES
- K895085 — WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT
- K895347 — MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT
- K895487 — TEMPORARY DENTAL CEMENT
- K895700 — AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
- K900002 — DOPPLER OPTION FOR PLATINUM
- K900029 — SPECTRASTIM 2000 MUSCLE STIMULATOR
- K900078 — SIMULTEST IMK PLUS(TM)
- K900117 — STELLITE COBALT/CHROMIUM BASE METAL ALLOY
- K900184 — LINGUAL SHEATH
- K900357 — GOLD CIRCLE COIN
- K900358 — SAXON WET LUBE
- K900359 — EMBRACE
- K900360 — SAXON ULTRA THIN
- K901014 — RADIOGRAPHIC INTENSIFYING SCREEN
- K901075 — LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.
- K901333 — BETA-2 MICROGLOBULIN EIA
- K895589 — MANUAL RESUSCITATOR
- K896730 — SUCTION CATHETER STRAIGHT/COUDE
- K896731 — OXYGEN CATHETERS
- K896873 — COULTER JT3
- K897125 — ATRIUM 2000, CHEST DRAIN
- K897133 — MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
- K897183 — SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS
- K900121 — ROCHE REAGENT FOR LDH
- K900173 — HYCOR ACCUPINCH MORPHINE TEST
- K900240 — DELFIA TBG KIT
- K900641 — CANNULA, SUCTION UTERINE
- K900695 — ENZYMUN TEST(R) PROLACTIN
- K900777 — ITEM #273 CONTACT LENS CASES
- K900778 — ITEM #272 MAGNIF-EYES CONTACT LENS CASE
- K901086 — ENZYMUN TEST(R) T4 (TOTAL THYROXINE)
- K901129 — BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER
- K901295 — PULMONAIR 40 PATIENT MANAGEMENT SYSTEM
- K896391 — BARD/ANGIOMED STENTS
- K897015 — GLUCOMETER GX BLOOD GLUCOSE METER
- K897072 — NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR
- K897162 — COULTER CHOLESTEROL REAGENT
- K900009 — NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
- K900021 — PERCU-SET(TM)
- K900060 — FREE T4 IMMUNOASSAY KIT
- K900680 — EFFNER ARTHROPERISCOPE/ARTHROSCOPE W/REMOV. OPTICS
- K900850 — EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
- K901045 — HCG SOLID PHASE COMPONENT SYSTEM
- K901090 — ELITECH GAMMA GT TEST KIT
- K901113 — MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD
- K901122 — TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE
- K901265 — COULTER MAGNESIUM REAGENT
- K894657 — POLYSTAN HEART-LUNG MACHINE SYSTEM
- K894784 — MODIFIED SHILEY FEMORAL VENOUS CANNULA
- K895463 — OSSEODENT(R) PRECISION DENTAL ATTACHMENTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.