FDA 510(k) clearances — page 995
clearances on record, most recent first.
Clearances — page 995
99,401–99,500 of 175,890- K960091 — ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
- K960110 — KIS MT3
- K960182 — DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
- K960354 — PERMAMESH-D HYDROXYLAPATITE MATRIX
- K960362 — PERMAMESH HYDROXYLAPATITE MATRIX
- K960471 — TRI-COUNT 20
- K960852 — HALL MODULAR ACETABULAR REAMER SYSTEM
- K960883 — INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8
- K936240 — SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
- K940048 — STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION
- K945302 — SLOAN STA-DRI PANT PROTECTOR
- K954062 — EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
- K954105 — EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
- K954124 — O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
- K954159 — DIGITAL IMAGING SYSTEM
- K954974 — PACE SAVER LITTLE JUNIOR (MODIFICATION)
- K955021 — QUANTA LITE PR3
- K955022 — QUANTA LITE MPO
- K955353 — ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
- K960005 — TRI-COURT 20-T
- K960090 — CALCOFLUOR WHITE STAIN KIT
- K960095 — BACTIDROP CALCOFLUOR WHITE
- K960117 — PLATFORM ONESTEP PREGNANCY HOME TEST
- K960298 — VIVASPIN 4 10,000 MW
- K960412 — T-3 MICROWELL EIA MODEL 7013
- K960436 — SELFCARE EARLY PREGNANCY TEST
- K960650 — NON PRESCRIPTION SUN GLASSES
- K955015 — ZYMED HOLTER SCANNER MODEL 2010
- K955234 — TRUPEAK PEAK FLOW METER
- K955843 — TAS PTONE
- K960014 — PRACTIFIX EXTERNAL FIXATION SYSTEM
- K960023 — KIRSHNER WIRES (K-WIRE) & STEINMANN PINS
- K960411 — MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS
- K960526 — PRIMIDONE EIA TEST
- K945847 — FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE
- K945848 — FRIALIT(R)-2 DENTAL IMPLANT
- K945849 — FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING
- K946277 — TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM
- K951185 — NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE
- K951261 — DFI-1000 AND DVS-475 IMAGING DEVICES
- K953752 — RT55 DIAGNOSTIC ULTRASOUND SYSTEM
- K953835 — LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
- K954172 — X-RAY VISIONS
- K954467 — CADPLAN BT
- K954487 — PRE POWDERED LATEX EXAMINATION GLOVES
- K955281 — ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES
- K955549 — OXLIFE OXYGEN CONCENTRATORS
- K955722 — FLEXON TEMPORARY CARDIAC PACER LEAD
- K955774 — VARIS PORTALVISION
- K955833 — NIOMED SURGICAL CAPS
- K955864 — J.B. S. C1-C2 CLAMP
- K955942 — BLADDERSCAN BVI 5000
- K960112 — KIS MT5
- K960165 — ALPHA-DENT COMPOSITE SURFACE SEALANT
- K960219 — PROLEX MESH
- K960270 — DENTALOGIC
- K960317 — LAURUS NEEDLE CORE BIOPSY SYSTEM
- K960340 — CONSENSUS APEX DOME HOLE PLUG
- K960480 — IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013
- K960547 — DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE
- K960878 — MAHLER ABDOMINAL WALL ELEVATOR
- K924313 — DIGITAL CONDUCTANCE METER
- K943843 — VARICELISA, MODIFICATION
- K953673 — ECLIPSE PROBE COVER
- K953773 — 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE
- K954648 — FEMRX OPERASTAR SYSTEM
- K955748 — DOYLE EXTRACTOR
- K960203 — G.E. STERILE AMNIOCENTESIS TRAY
- K960469 — DETECT CYTOLOGY BRUSH II
- K943025 — FREEMAN/SAMUELSON TOTAL KNEE SYSTEM
- K951193 — CLINICAL VITAL SIGNS MONITOR, MODEL #52STP-E1
- K954952 — MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL
- K955339 — HYDROLOGY 5000
- K955680 — SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED
- K955720 — AMAX CS-190 COAGULATION ANALYZER SYSTEM
- K955730 — EBI ANTERIOR CERVICAL SPINE SYSTEM
- K955761 — TIBIA ORTHONAIL
- K955781 — ALBUMIN
- K955863 — ALLDRESS MULTI LAYERED WOUND DRESSING
- K955884 — COORDINATE REVISION KNEE SYSTEM
- K955927 — BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)
- K955939 — CALCIUM REAGENT
- K955940 — TOTAL BILIRUBIN REAGENT
- K960038 — SPECTRUM DESIGNS SILICONE BLOCK
- K960154 — PSA CONTROLS
- K960349 — PERMARIDGE HYDROXYLAPATITE MATRIX
- K952095 — VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
- K953392 — HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)
- K954006 — YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY
- K954164 — HYSTEROSCOPE
- K954415 — PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
- K954556 — SURGICAL CAP
- K955338 — DRYTIME FOR POTTY TRAINING
- K955426 — STERITEC CROSS-CHECKS
- K955645 — CATH-GUIDE
- K955657 — NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
- K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
- K955724 — KC 1A COAGULATION ANALYZER/SET
- K955785 — TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
- K955812 — SYSCON TURMOR MARKER CONTROL
Data sourced from openFDA. This site is unofficial and independent of the FDA.