FDA 510(k) clearances — page 524
clearances on record, most recent first.
Clearances — page 524
52,301–52,400 of 175,825- K092375 — MODIFICATION TO SI JOINT FUSION SYSTEM
- K092396 — SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
- K092413 — INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
- K092430 — 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
- K092455 — MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
- K092552 — CLO-SURPLUS P.A.D.
- K092576 — GEM HEART ONE/ONE+
- K082939 — COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
- K083288 — DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER
- K083602 — KAPPA LIGHT CHAINS
- K090315 — STAXX XD SYSTEM
- K090760 — THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
- K090846 — GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
- K091066 — COMFORT TWIN NASAL MASK
- K091155 — ASCEND
- K091366 — INSUFLOW DEWHEART
- K091495 — SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
- K091537 — CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH
- K091632 — SPK SEALANT
- K091635 — VENUS DIAMOND FLOW
- K091685 — KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600
- K091861 — VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
- K092324 — SPIROPRO
- K092332 — JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)
- K092373 — ICS CHARTR EP 200
- K092412 — STRONG IMPLANT HANDPIECES
- K083724 — WIENER LAB. URINE STRIP 10 AND 11
- K091166 — IMRX
- K091312 — PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
- K091359 — GSO PCT SPINAL SYSTEM
- K091718 — NEUTRASAL
- K091798 — MERETE COMPRESSION SCREWS
- K091841 — BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000
- K091877 — CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL
- K091974 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K092470 — OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
- K082391 — PRIMAEVA MEDICAL RENESIS SYSTEM
- K083428 — F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
- K083665 — VERIFY SCBI 275F 3-10
- K083744 — BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
- K083846 — XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
- K090156 — ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000
- K090394 — VALVED TEARWAY INTRODUCER
- K090496 — QWIKLEAD REUSABLE ELECTROCARDIOGRAPH ELECTRODE PATCH
- K091676 — MC-245, MC-246, MC-247, MC-341, MC-343, MC-344
- K091869 — SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS
- K092284 — LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200
- K092393 — EK/P. AERUGINOSA PNA FISH
- K092419 — AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS
- K082723 — GRINDGUARD
- K091142 — TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
- K091287 — VS-SENSE TEST
- K091778 — VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
- K090304 — WAVEON WRX BONE FIXATION SYSTEM
- K090309 — LAGIS ENDOSCOPIC INSTRUMENTS
- K090377 — SINUS QUICK EB SYSTEM
- K090762 — LEDA
- K091419 — VICKS POWERSHOT DRY THROAT & MOUTH RELIEF
- K091705 — PRIMER PLUS
- K091706 — QUATTRO PORCELAIN SYSTEM
- K091733 — VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-2500
- K091753 — ELVIS HSV ID AND D3 TYPING TEST SYSTEM
- K091844 — ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS
- K092027 — CARESCAPE MONITOR B850
- K092285 — PORTABLE DOSIMETER DOSE VERIFICATION SYSTEM, MODEL TD-RD-90
- K092300 — MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
- K092458 — PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
- K092486 — VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT
- K082040 — MINISILK FT
- K083270 — WMT COMPOSITE DBM
- K083867 — ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
- K090811 — INSPIRA HD, MODEL: NL1000
- K090869 — MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
- K091971 — AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM
- K092286 — FOX SV PTA CATHETER
- K092310 — SEGUIN ANNULOPLASTY RING
- K092405 — MAMMOSITE MULTI LUMEN
- K092519 — SYNGO.X
- K092537 — DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540
- K083582 — SIGN HIP CONSTRUCT (SHC), MODEL: 701
- K083608 — ERBE HYBRID KNIFE
- K090456 — INSUFLOW
- K090895 — EKG-PLUS II SOFTWARE
- K091338 — COLLASORB COLLAGEN WOUND DRESSING
- K091398 — ARTHROSCOPE
- K091820 — CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM
- K092423 — XPECT FLU A & B
- K092572 — CORE*IT DUAL
- K083208 — SATURN ACTIVE LASER SYSTEM
- K090258 — VENTURI NPWT V. II ADVANCED VACUUM SYSTEM
- K090936 — SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
- K091144 — SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
- K091251 — CERNER FETALINK (VERSION 1.0)
- K091292 — BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771
- K091423 — PROFEMUR HIP SYSTEM MODULAR NECKS
- K091439 — HEAD FIXATION ARC AND TABLE BASE
- K091600 — DIRECTVISION GUIDE SYSTEM
- K091821 — COMMANDER 111, MODEL CD300-CD399
- K091897 — BLOOD PRESSURE MONITOR, MODEL FORA P11/TD-3019
- K092004 — GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
Data sourced from openFDA. This site is unofficial and independent of the FDA.