FDA 510(k) clearances — page 862
clearances on record, most recent first.
Clearances — page 862
86,101–86,200 of 175,890- K991114 — REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
- K991291 — STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION
- K991338 — BOVINE SERUM ALBUMIN (BSA)
- K991343 — PVP (POLYVINYLPYRROLIDONE)
- K991477 — SPIN SNAP-OFF SCREW
- K991500 — SMITH & NEPHEW SUTURE LOK
- K991509 — PRO-PORTION CLEANER/DISINFECTANT
- K991567 — SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
- K991616 — CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K991622 — 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER
- K991649 — DEPUY ROCKWOOD CLAVICLE PIN
- K991869 — COBREX HIP STEM, MODEL 01-128-XXXXX
- K992151 — REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
- K972772 — ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING
- K990872 — SCLERAL PLUGS, 19 AND 20 GAUGE
- K991072 — AHMED GLAUCOMA VALVE IMPLANT
- K991560 — NASO-LARYNGO-PHARYNGOSCOPE
- K991733 — ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
- K991992 — ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
- K992163 — ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS
- K992217 — AT HOME DRUG TEST, MODEL 9175
- K982326 — MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
- K982943 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
- K983203 — IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
- K984512 — NITRILON CORRECT-TOUCH
- K984639 — THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER
- K990135 — TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE
- K990237 — TROCAR SYSTEM ACCORDING TO HASSON
- K990719 — EARLOOP FACE MASK
- K991267 — SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A
- K991272 — CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E
- K991276 — PASS/FAIL CHALLENGE PACK
- K991285 — LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE
- K991297 — UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES
- K991300 — BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
- K991303 — VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE
- K991336 — BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY
- K991377 — OMNISONICS FLEXIBLE FIBER OPTIC ENDOSCOPE AND COUPLER
- K991400 — PARIETENE POLYPROPYLENE MESH
- K991485 — SYNERGY POROUS SIZE 8 HIP STEM
- K991650 — CMV BRITE TURBO KIT
- K991900 — XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40
- K991917 — OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET
- K991940 — BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)
- K992031 — LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN)
- K992065 — GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD
- K992083 — SCATTERFREE LATERAL EMITTING FIBER
- K992084 — CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER
- K992191 — ETI-EA-G ASSAY
- K992208 — GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM
- K992230 — OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP
- K983504 — PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST
- K984295 — INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
- K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY
- K990649 — GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS
- K990761 — TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE
- K990843 — SERUM CROSSLAPS ONE STEP ELISA
- K991222 — CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
- K991450 — ETCHING GEL
- K991554 — GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K991602 — EPTFE RINGED GORE-TEX VASCULAR GRAFT
- K991605 — CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION
- K991624 — POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES
- K991774 — ACRON MC MODIFICATION
- K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
- K991808 — OPTIBOND SOLO PLUS 2
- K983764 — VIEWPOINT TOOLS- STERRAD
- K984033 — ATLAS MONITOR
- K990234 — QUALISYS PSA IMMUNOASSAY
- K990355 — STAINLESS STEEL SOFT SUTURE WIRE
- K991211 — EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
- K991225 — MTI 1 ML SYRINGE
- K991235 — SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)
- K991238 — FCI CRAWFORD PROBE INTUBATION SETS
- K991263 — THERMOPLATE
- K991337 — SPERM MAINTENANCE MEDIUM WITH GLYCEROL
- K991341 — ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION
- K991342 — PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION
- K991572 — ISOLUX SURGICAL HEADLIGHT
- K991590 — C-LEG (3C100)
- K991807 — TITANIUM LOW PROFILE SCREWS
- K992155 — VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7
- K984090 — SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A)
- K990818 — RAPIDONE - MARIJUANA TEST
- K991479 — VISER PENILE TUMESCENCE MONITOR
- K991711 — BISTITE II SC
- K991787 — N LATEX IGE MONO REAGENT
- K991849 — NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC
- K991852 — OCUSYSTEM ART ADVANTAGE, MODEL 995
- K992054 — ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS
- K981938 — TAMPA HYPERBARIC MONOPLACE CHAMBER
- K982180 — DURAGEN DURAL GRAFT MATRIX
- K983518 — LIFESTYLES XTRA PLEASURE
- K991323 — SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
- K991434 — QUADRATURE WRIST COIL, MODEL 445PH-64
- K991468 — IMMERGE IMAGE CORRELATION
- K991537 — SAMSUNG RAYPAX SYSTEM
- K991955 — MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION
- K992068 — STATUS STIK, ACCUSIGN STIK
- K992105 — IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.