FDA 510(k) clearances — page 988
clearances on record, most recent first.
Clearances — page 988
98,701–98,800 of 175,890- K955304 — CRICKET
- K955777 — PMMA CLASIC
- K960821 — SLT FUMICH PROBE GUIDE
- K960954 — KETAC-MOLAR APLICAP
- K961057 — DURALASTIC SHEETING II
- K961067 — BURN-AID HYDROGEL,BURN DRESSING,BURN BLANKET
- K961087 — DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS
- K961168 — VIEWPOINT
- K961224 — HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYSTEM
- K961286 — STUSSY SUNGLASSES/A.J. MORGAN SUNGLASSES
- K961524 — STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS
- K961746 — CHRONOSWISS,BALENO,BONIA,OTMAR ALT, NEW JERSEY
- K954457 — MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER
- K954980 — PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
- K955356 — ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
- K955533 — DIASTAT VASCULAR ACCESS GRAFT
- K955585 — V2 INJECTION SITE
- K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY
- K960058 — OXITEMP, 3301T SA
- K960277 — PROTECTIVE LATEX POWDERED GLOVES
- K960713 — 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)
- K960969 — GALVA 5-T
- K961015 — SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE
- K961195 — CHEM-CHEX STAT
- K961196 — EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
- K961256 — SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT
- K961273 — AED CALIBRATORS
- K961280 — SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
- K961327 — BEC NEEDLELESS INJECTION SITE
- K961349 — INJECTION GOLD PROBE
- K961492 — HYDRO-SURG LAPAROSCOPIC IRRIGATON MODELS 0026000. 0026010
- K944867 — TOXOSTAT
- K945105 — POLY/PLATINUM WIRE PISTON
- K950712 — PORTABLE ENDOSCOPY SYSTEM
- K951877 — AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
- K953083 — HOSPITAL LAUNDRY SERVICES SURGICAL PACKS
- K954318 — ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
- K954325 — NEOLON NEOPRENE SURGICAL GLOVES
- K955379 — IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)
- K955380 — IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)
- K955412 — A.S.D. SAFETY TROCAR
- K955583 — VIFS
- K955659 — DRUGBOX
- K960639 — ABUTMENT SELECTION KIT
- K960768 — LASER FIBER DELIVERY/CLEANING CATHETER
- K960787 — TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
- K960867 — FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532)
- K961178 — KARL STORZ INTUBATION FIBERSCOPE
- K961670 — CLARITY
- K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
- K950625 — ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
- K950989 — CARDIOSMART
- K951100 — ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
- K953116 — WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER
- K960592 — ELECTROLYTE STANDARDS
- K960622 — I-SCAN
- K960648 — PHEM-CHEK
- K960677 — KANGAROO JEJUNAL FEEDING SYSTEM
- K960735 — EVERGLORY SUNGLASSES
- K961513 — PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET
- K961523 — TINY TOON SUNGLASSES & CABBAGE PATCH KIDS SUNGLASSES
- K961603 — SUN CLIP
- K950482 — ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
- K954585 — RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE
- K954775 — FLO-STAT FLUID MONITORING SYSTEM
- K955121 — HEARTPORT ENDOARTERIAL RETURN CANNUAL
- K955126 — LMI BILIARY CATHETER
- K960470 — NEURO-PATCH
- K960485 — SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
- K960593 — SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100
- K960820 — SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER
- K960889 — SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS
- K961120 — MARKER SYSTEM FOR STEREOTAXIC NAVIGATION
- K961141 — EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220
- K961262 — WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS
- K961609 — MODEL 1220, OR E-NET (54-62 CM)
- K961683 — JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY
- K935720 — ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM
- K954112 — VYGON LIFEVAC MID-LINE TRAY
- K954771 — TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
- K955092 — ACCURAD IMAGE MANAGEMENT SYSTEM, AUTORAD, REGUSTRATION STATION, ARCHIVE SERVER, PRINT SPOOLER, ANALOG & DIGITAL ACQUIRE
- K955519 — ANALYTICAL REVIEW STATION
- K955851 — AXSYM VANCOMYCIN II
- K960518 — THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM
- K960632 — KANGAROO FEEDING TUBE PLACMENT STYLET
- K960673 — OSAP
- K960778 — ISOLAIR APR TYPE N95
- K960799 — ORTHO-ICE
- K961442 — UNIVERSAL DRAINAGE TRAY
- K950967 — M.I.C.
- K954215 — MINIGUARD
- K954830 — ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
- K954831 — ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
- K955728 — CORDIS BILIARY STENT
- K960556 — BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE
- K960617 — ADVANCE TIBIAL COMPONENT
- K960660 — HEMISPHERE ACETABULAR CUP
- K960782 — TITANIUM TUBE TO TUBE CLAMP
- K960876 — FIVE STAR BRONCHOSCOPE
- K961027 — ORTHOFIX TIBIAL NAILING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.