FDA 510(k) clearances — page 701
clearances on record, most recent first.
Clearances — page 701
70,001–70,100 of 175,825- K033908 — N HIGH SENSITIVITY CRP
- K033982 — MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TEST
- K033989 — MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69
- K033991 — MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
- K040028 — CA-1500
- DEN040001 — CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
- K031321 — LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001
- K031686 — AEROMIST LT, MODEL HCS15004
- K031860 — SK MED ME202 MONITORING MIXER
- K032511 — INTUITION IMAGE
- K033176 — TRISTAR AESTHETIC WORKSTATION LASER
- K033409 — AMERSHAM HEALTH NEEDLE-GUARD
- K033632 — VARIFLEX
- K033865 — IDEIA PCE CHLAMYDIA
- K034019 — POLY PER-Q-CATH PICC CATHETERS
- K034020 — GROSHONG NXT PICC CATHETERS
- K034031 — 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE
- K034040 — ESPRIT VENTILATOR, MODEL V1000
- K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I
- K040015 — MODIFICATION TO PRISMALIX SURGICAL LIGHT
- K032604 — GII SPINAL FIXATION SYSTEM
- K032641 — MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
- K032799 — NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
- K033437 — SPHINX LASER SYSTEMS
- K033476 — MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
- K033507 — MRJ
- K033744 — AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA
- K033902 — ONTRAK TESTCUP II AND ONSITE CUPKIT
- K033956 — MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)
- K040018 — EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
- K030341 — MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
- K031617 — MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
- K032124 — DUREX PLAY LUBRICANT
- K032303 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
- K033227 — LUXAFORM PLUS
- K033328 — NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
- K033331 — CANDELA CBEAM PULSE DYE LASER SYSTEM
- K033344 — LIGAND PLUS CONTROL LEVEL 1-3
- K033363 — ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
- K033461 — CANDELA VBEAM PULSE DYE LASER SYSTEM
- K033521 — BISBLOCK
- K033585 — DIAPEX
- K033628 — ARTIC
- K033658 — E.P.T. PREGNANCY TEST
- K033692 — POWDERED VINYL EXAMINATION GLOVES
- K033693 — POWDER-FREE VINYL EXAMINATION GLOVES
- K033726 — PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER
- K033877 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
- K033903 — MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
- K033904 — PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
- K033915 — MODIFICATION TO SERAQUEST EB VCA IGG
- K024185 — BIODHOC
- K030267 — EEG MONITOR WITH BIS, MODEL A-2000
- K031128 — B-SMART, MODEL B-01
- K032108 — SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
- K032891 — TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
- K033279 — GOLD DENTAL CASTING ALLOYS
- K033310 — REMEEX SYSTEM FOR URINARY INCONTINENCE
- K033342 — SCORPIO KNEE SYSTEM - TIBIAL INSERTS
- K033376 — UGYTEX MESH
- K033406 — SMALL BONE FIXATION SYSTEM
- K033423 — REVOLIX LASER SYSTEMS
- K033432 — LEXATITE QUICK ACRYLIC
- K033455 — ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
- K033462 — EARLY CLEAVAGE MEDIUM (ECM)
- K033472 — TESCERA U-BAR AND BARRELS
- K033483 — KLS-MARTIN ORTHO ANCHORAGE SYSTEM
- K033513 — EASI ECG ALGORITHM
- K033639 — ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
- K033654 — FORCE FIBER
- K033675 — PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
- K033773 — CONCEPT HP ADD-ON; CONCEPT HP ENAMEL
- K033780 — MODIFICATION TO SERAQUEST VCA IGM
- K033815 — BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
- K033890 — ADVANCE DOUBLE HIGH INSERT
- K033927 — ARTHOSCOPY PUMP A115
- K033964 — SOLAR 9500 INFORMATION MONITOR
- K034002 — GAMMA3 NAIL SYSTEM
- K034023 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1
- K034065 — MODIFICATION TO X-PORT DUO PORT
- K030739 — INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
- K031896 — NASAL-AIR CRITICAL CARE
- K031908 — MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)
- K032245 — ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239
- K032972 — AEROCHAMBER MAX VALVED HOLDING CHAMBER
- K033087 — ORACLE ORAL MASK, MODEL HC451A
- K033557 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE
- K033560 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
- K033853 — MODIFICATION TO V-CATH POLY PICC
- K033936 — BARD ELIMINATOR PET BALLOON DILATORS
- K023506 — SURGICAL MEDICAL DEVICE CAUTERY
- K032796 — IBL C3D-CIC EIA TEST
- K032966 — THE ANSWER SCREW SUPPLEMENTATION SYSTEM
- K033289 — MODIFICATION TO JET-X HA COATED HALF PINS
- K033293 — MED-LOGICS, MODEL ML7090
- K033312 — EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
- K033323 — D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
- K033556 — SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
- K033569 — FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH
- K033850 — MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
Data sourced from openFDA. This site is unofficial and independent of the FDA.