FDA 510(k) clearances — page 527
clearances on record, most recent first.
Clearances — page 527
52,601–52,700 of 175,825- K091961 — MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
- K091966 — ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076-6040, 2092-6040, 2105-6040
- K091988 — MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076
- K091997 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7962
- K092015 — PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
- K092045 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-738 AND KD-739
- K092086 — AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
- K082093 — BULLSEYE BILIARY STENT SYSTEM
- K083242 — NEUROSIGN AVALANCHE MOTOR NERVE MONITOR
- K083409 — POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL
- K090054 — ATLAS IMPLANT SYSTEM - WIDE PLUS
- K090210 — MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
- K090996 — PONTO PRO
- K091197 — PLANMECA PROSENSOR
- K091403 — MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
- K091405 — PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
- K091594 — HEART-EXERCISE
- K091788 — PANTA NAIL (DIA. 10MM), PANTA NAIL XL
- K092054 — MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
- K092179 — APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
- K083052 — EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA)
- K090733 — PMT HALO SYSTEM
- K090828 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES
- K091285 — AL T LASER, MODEL AVI HPLL-12
- K091459 — PHILIPS NM3 MONITOR, MODEL 7900
- K091519 — HAEMOBAND MULTI-LIGATOR
- K091690 — SHARP CHUTE
- K091829 — PLS PORTABLE LIGHT SOURCE
- K092023 — NAVIJECT SUB2-1P, MODEL: LP604430
- K092159 — ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
- K083377 — ACCUPEN
- K083614 — SONOLITH I-SYS LITHOTRIPER
- K090154 — SPI DENTAL IMPLANT INICELL
- K090477 — ALPINE PEDICLE SCREW SYSTEM
- K090699 — VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
- K090738 — THERMOFLO HCH, THERMOFLO FILTER
- K091054 — WALK400H
- K091147 — POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
- K091661 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K091663 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K092122 — GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
- K081603 — DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
- K082848 — NUBIC AND RABEA DEVICES
- K083074 — AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
- K083105 — KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411
- K083294 — VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST
- K083421 — MR-TOUCH OPTION
- K083461 — IMAGINE TC SKIN THERAPY SYSTEM
- K090007 — JUMAO OXYGEN CONCENTRATOR, MODEL JM-07000HI, JM-07000I, JM-07000
- K090438 — REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR
- K090612 — BENACEL
- K090937 — E-STATIS 40 SYSTEM
- K091110 — SPINAL EDGE TITAN PEDICLE SCREW SYSTEM
- K091141 — THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS
- K091185 — 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER
- K091235 — RAMP RSV ASSAY
- K091258 — EXTRAFIX EXTERNAL FIXATION SYSTEM
- K091294 — LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,
- K091454 — PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
- K091513 — SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
- K091577 — EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
- K091580 — PICA WHOLE BODY MRI SYSTEM
- K091985 — UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE
- K092030 — ELATION MB METAL REINFORCED PLASTIC BRACKET
- K080380 — SAS INFLUENZA A & B TEST
- K083670 — UNIVERSAL, AESTHETICA, NATEA, NATURA
- K090245 — SOLO INSULIN PATCH PUMP
- K090646 — CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
- K090766 — LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
- K090817 — IONOLUX
- K090879 — INSUFLOW CO2IONSHIELD
- K091028 — OMNI 5 TOTAL O2 DELIVERY SYSTEM
- K091300 — ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079
- K091421 — NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED)
- K091586 — VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN
- K091894 — TEMPORARY C&B COMPOSITE
- K082647 — POWDERED VINYL PATIENT EXAMINATION GLOVES
- K083113 — ACTICOAT FLEX 7 DRESSING
- K083761 — ALATECH POWDER FREE LATEX EXAMINATION GLOVE
- K090320 — CONQUEST SPINAL SYSTEM
- K090406 — EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
- K090485 — COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
- K090902 — SPIDER SINGLE PORT SURGICAL DEVICE, SUPPORT ARM ACCESSORY, MODEL 90001, 90002, 90003
- K091058 — ADKINS STRUT
- K091163 — PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST
- K091252 — IMPLANT CENTER 2
- K091264 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
- K091355 — DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
- K091383 — VINYL POWDER FREE EXAMINATION GLOVE
- K091388 — GCUC-505
- K091429 — VINYL POWDER FREE EXAMINATION GLOVE
- K091502 — NUVASIVE SPHERX II SYSTEM
- K091832 — ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
- K083594 — EZ HSG CATHETER.FOAMSEAL CATHETER
- K090829 — PARI PEP S
- K090830 — LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
- K091075 — ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
- K091645 — GOLD ANCHOR
- K091911 — BOLUS COMPENSATOR
- K092081 — QXLINK
Data sourced from openFDA. This site is unofficial and independent of the FDA.