FDA 510(k) clearances — page 954
clearances on record, most recent first.
Clearances — page 954
95,301–95,400 of 175,890- K964852 — RADIACARE ORAL WOUND RINSE
- K964860 — MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
- K964871 — BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
- K970336 — MMB CALIBRATOR
- K970393 — THYROID STIMULATING HORMONE METHOD
- K970527 — ABBOTT HCG SERUM CONTROLS
- K945117 — DELTA
- K953076 — TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
- K960309 — AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)
- K962534 — THERA-MIST NEBULIZER MODEL-P3000
- K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
- K963375 — CARDIACMONITOR
- K963576 — MOBILE MEDICAL MONITOR (M3(A))
- K963654 — QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
- K964353 — CYBERLASE CO2 LASER SYSTEM
- K964820 — MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
- K964834 — ISOCAM II (DUAL HEAD GAMMA CAMERA)
- K964863 — MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN
- K964876 — SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET
- K964888 — HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II
- K964893 — HANSSON PIN SYSTEM
- K964930 — STRYKER SAPHENOUS VEIN HARVEST SCOPE
- K965056 — OSTEONICS SCREW HOLE PLUGS
- K965098 — INTRAMEDULLARY NAIL SYSTEM
- K965241 — BIPOLAR SUCTION COAGULATOR
- K970023 — MEDNEXT SURGICAL BUR
- K970040 — SPINE-TECH BONE HARVESTER
- K970337 — HA GLOBAL TAPER (GT) TAPERED HIP STEM
- K970351 — GLOBAL TAPER SPECTRON HIP STEMS
- K962666 — BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN
- K964736 — BERGEN 610 BIPOLAR COAGULATOR
- K964845 — JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING
- K964847 — NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING
- K964968 — MR EXTENSION SET (001)
- K965073 — 9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
- K965216 — ARGI-SATIN OR OPTI0-STAR
- K970168 — 3M QUIKPLUS SYSTEM
- K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
- K961809 — SHE-LI TENS STIMULATOR MODEL SL-101 RX
- K961862 — MODELS IDA-2 PLUS AND IPT-1
- K963351 — LIFESHIELD BLUNT CANNULA
- K963406 — UHE COLLIMATOR (210591)
- K963662 — GALILEO EVOKED POTENTIALRE
- K964018 — PHACOILLUMINATOR - FIBEROPTIC SLEEVE
- K964112 — BERENSTEIN COIL
- K964181 — SPONGETRAC
- K964322 — VIPOR UNIT
- K964780 — BARD DIRECTOR GUIDEWIRE (000560)
- K964808 — SPETEMP
- K964813 — MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
- K964990 — HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
- K965208 — POLYFIN EXTENSION SET, MODELS 126 AND 128
- K970039 — ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001)
- K970057 — AHS OMEGA SP
- K970263 — PM 2002 CC PROLINE
- K962872 — RESPIFLO
- K962874 — RESPIFLO/S
- K962981 — CAPIOX SP PUMP HEAD
- K963425 — GENZYME DIAGNOSTICS CONTRAST MONO
- K963568 — MASK SURGICAL
- K963841 — EZTEST
- K963917 — HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT
- K963970 — ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM URETHRAL WARMING SYSTEM
- K964142 — MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
- K964364 — DISPOSABLE APRON
- K964692 — PERFECTIM
- K964768 — THREADLOC DENTAL IMPLANT SYSTEMS
- K964782 — MEDRAD CONTRAST HOLDER
- K964850 — SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
- K964935 — SUTURE LOCK
- K964943 — SUNGLASSES (NON-PRESCRIPTION)
- K965021 — NON-PRESCRIPTION SUNGLASSES
- K965118 — ENDOCARE MONOPOLAR ELECTRODE
- K965135 — LIFECORE CONICAL ABUTMENT
- K965243 — ENDOCARE ELECTROSURGICAL ELECTRODE
- K970126 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
- K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
- K970297 — OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
- K970443 — HOLLISTER RETRACTED PENIS POUCH
- K962558 — CHLAMYDIA IGG ELISA TEST SYSTEM
- K962827 — ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)
- K963678 — CARETONE II
- K964013 — MITEK ABSORBABLE TOGGLE ANCHOR
- K964752 — KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER
- K964778 — HI-STAR MRI IMAGING SYSTEM
- K964945 — INNOVASIVE DEVICES ROTATOR CUFF FASTNER
- K964951 — KINEMAX PLUS TIBIAL SPACERS
- K964957 — INTERMITTENT COMPRESSOR SYSTEM
- K964975 — COHORT DISCECTOMY SYSTEMS (CDS)
- K965005 — IAMIN IMPREGNATED GAUZE DRESSING
- K960097 — CHARTR EP
- K961982 — TRI-FLOW THREE WAY STOPCOCK
- K962243 — VASOTHERM
- K962703 — THEE THERMASTIM
- K962765 — CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)
- K962850 — TUM-E-VAC
- K963053 — 9000 SERIES FILTER & FILTER/HME
- K963081 — INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS
- K964055 — FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)
- K964699 — RHEO DOPPLEX II (RD 2)
Data sourced from openFDA. This site is unofficial and independent of the FDA.