FDA 510(k) clearances — page 1259
clearances on record, most recent first.
Clearances — page 1259
125,801–125,900 of 175,890- K902059 — AUTOWAND(TM) 7XXX SERIES
- K902117 — FESAN SUNGLASSES
- K902186 — SUNGLASSES
- K902455 — ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
- K902457 — ABNORMAL GLYCOHEMOGLOBIN CONTROL
- K902474 — WEEVAC 1 PORTABLE RESCUE STRETCHER
- K902496 — LANDERS VITRECTOMY LENS RING W/INFUSION
- K902509 — SAXON RIBBED CONDOMS
- K902751 — MITEK ANCHOR II
- K902792 — TOXOPLASMA GONDII IGG
- K902912 — THERMOSCAN-INSTANT THERMOMETER MODEL IR-4000
- K894228 — KRONNER SPHERICAL CUTTERS
- K896536 — PHARMATRONICS NEBULIZER
- K901308 — SPIRO ANALYZER MODEL ST 250
- K901313 — INSTRUMENTS FOR NEUROLOGICAL SURGERY
- K901406 — ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
- K901530 — WALLACE INTRAUTERINE INSEMINATION CATHETER
- K901845 — TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX
- K902065 — E.T. TAPE II
- K902263 — OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
- K902916 — PRECISION MEDICAL NEB BLOCK
- K902917 — PRECISION MEDICAL ELIMINATOR
- K901180 — FOLEY CATHETER INSERTION TRAY (30CC)
- K901181 — CATHETER CARE TRAY
- K901183 — URETHRAL CATHETER TRAY (PVC)
- K901184 — URETHRAL CATHETER TRAY (LATEX)
- K901185 — FOLEY CATHETER INSERTION TRAY (10CC)
- K901512 — L SOPHIA
- K901553 — SURG-K SURGICAL KERATOMETER
- K901655 — 1 TRANSDUCER FOR COMBISON 310A
- K901860 — INTRA III AND INTRA IV HEARING AIDS
- K901874 — COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY
- K902007 — I3SYSTEM-ABD
- K902022 — SEAL RITE(TM)
- K895770 — EXEL HUBER INFUSION SET
- K895923 — METRICARE ENTERAL FEEDING SYSTEM
- K896364 — DECIDENT
- K900087 — GENESYS 6000 GAMMA COUNTER
- K901040 — IONOMETER EH-F AND ACCESSORIES
- K901382 — ISOFLO(TM) HIGH PRESSURE INJECTION LINES
- K901527 — BIURET (COLORMETRIC), TOTAL PROTEIN
- K901706 — LIGHT, HEAD, EXAMINATION
- K901802 — TOY SUNGLASSES
- K902035 — FLEXIBLE EXTENDER
- K902036 — STERI-VAC GAS STERILIZER MODEL 5XL
- K902094 — BLOOD GAS/ISE CONTROLS
- K902180 — TRACHEAL TUBE STYLET
- K902257 — CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II)
- K902293 — ANGIOGRAPHY DRAPE PACK
- K902300 — EASY BREATHER MODEL 100 ACCESSORIES
- K902344 — ATI DISPOSABLE BIOLOGICAL TEST PACK FOR STEAM STER
- K902409 — BECTON DICKINSON 360 INFUSER (TM) SYSTEM
- K902580 — EMIT(R) II BARBITURATE ASSAY
- K902592 — EPC ELECTRONIC PIPETTING SYSTEM
- K902616 — BILIRUBIN CONTROL
- K902630 — BILATERAL TMJ COIL
- K902679 — MODELS 4201, 4231 & 4235 EXTENSION CABLES
- K902698 — AFFINITY PROLACTIN TEST SYSTEM
- K902719 — SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT
- K902890 — ASPEN 3 OXYGEN CONCENTRATOR
- K896500 — CWD/PPG MODULE
- K900365 — PAG MICROPROCESSOR-CONTROLLED MODULE
- K900451 — VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE
- K900664 — DISPOSABLE COURNAND, SELDINGER & ONE-WALL NEEDLES
- K900722 — LOW FLOW N2O/02O MICROBLENDER
- K900783 — MDI ADAPTOR
- K901232 — IMPRAFLO AUTOTRANSFUSION DEVICE
- K901555 — MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
- K901819 — MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
- K902080 — RED DOT 2269 INFANT MONITORING ELECTRODE
- K902114 — CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR
- K902590 — THREADED PADDLE PAIRS, INTERNAL ADULT PEDI INFANT
- K902759 — COBE CLOSED WOUND DRAINAGE KIT
- K902850 — ZEPPELIN INSTRUMENTS
- K884120 — TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
- K895520 — PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A
- K896742 — FOCUS J81F, J83F, J41F, J43F PACING LEADS
- K897124 — SMALL VESSEL BALLOON DILATATION CATHETER
- K900220 — TRANS-PACE 100
- K900247 — CBM-3000/CBM-2000/CBM-7000 BLOOD PRESSURE SYSTEM
- K900311 — ARTERIAL EMBOLECTOMY CATHETER
- K900350 — LEOCOR CORFLO(TM) PUMP
- K900460 — MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER
- K900540 — TRAM PATIENT MONITOR
- K900822 — HYDRO-SIL(TM) COATED GUIDEWIRES
- K901410 — TECHNICON RA-2000(TM) SYSTEM
- K901762 — PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
- K901889 — FUKUDA DENSHI MODEL HJ-310
- K901947 — CARDISUNY 501AB
- K901948 — CARDISUNY 501BIII
- K902147 — ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
- K902194 — MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT
- K902208 — MODIFIED OVUGEN
- K902235 — LVM QUALITY CONTROL SERUM
- K902414 — OPTI-RAY SUNGLASSES
- K902476 — CALCIUM:ARSENAZO III
- K902479 — CALCIUM REAGENT CODE 7732, 7733, 7532 & 7432
- K902560 — ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
- K902671 — COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER
- K902673 — HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND
Data sourced from openFDA. This site is unofficial and independent of the FDA.