FDA 510(k) clearances — page 656
clearances on record, most recent first.
Clearances — page 656
65,501–65,600 of 176,637- K052016 — NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
- K052017 — CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
- K052074 — JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,
- K042915 — O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT
- K050421 — MS 4/5 HEMATOLOGY ANALYZER
- K050468 — TRIABSORB COMPOSITE SCREW
- K051405 — REGENSIS PERICARDIAL PATCH
- K051473 — LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021
- K052035 — CANADY PLASMA PROBES
- K052060 — OPTI-AMP DC-POWERED
- K052086 — ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER
- K052144 — TSRH SPINAL SYSTEM
- K052198 — RELIEVA SINUS BALLOON INFLATION DEVICE
- K052251 — DRYSTAR MODEL 5500
- K051301 — PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
- K051380 — TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM
- K051421 — INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
- K051657 — A-DEC SELF-CONTAINED WATER SYSTEM
- K051889 — CAREVENT CA AND DRA
- K051979 — ORS MODEL 6000 ENDOSCOPE HOLDER
- K052129 — LUMENIS 1000 INTEGRATED SLIT LAMP
- K042758 — POLYTECH PULMONARY FUNCTION FILTER
- K050269 — U1 HIP SYSTEM - BIPOLAR
- K050558 — MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
- K051177 — PVC AND SILICONE MANUAL RESUSCITATORS
- K051413 — ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
- K051905 — UROPLASTY RIGID ENDOSCOPIC NEEDLE
- K052067 — DOPPLER GUIDED PROCTOSCOPE, MODEL 500H
- K052072 — THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES
- K050170 — FORTOSS VITAL BONE GRAFT SUBSTITUTE
- K050399 — MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160
- K050889 — FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH
- K051171 — STINGRAY EPIDURAL CATHETER CONNECTOR
- K051296 — SIJF CANNULATED SCREW SYSTEM
- K051574 — NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
- K051816 — LUMIWAVE 1X4 INFRARED THERAPY DEVICE
- K052049 — PHILIPS 12-LEAD ALGORITHM
- K052066 — CEEGRAPH/SLEEPSCAN NETLINK TRAVELER
- K052101 — C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C
- K050234 — REMOTE CARE
- K051115 — SENTINEL IRON LIQUID
- K051962 — ULTRA HDL
- K052022 — ASAHI PTCA GUIDE WIRE FIELDER
- K052036 — ATB ADVANCE PTA DILATATION CATHETER
- K052062 — ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
- K052064 — ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
- K052080 — MATRYX INTERFERENCE SCREW
- K052114 — BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
- K052136 — GR17 DIGITAL DETECTOR
- K052157 — INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ
- K050336 — OPD-STATION SOFTWARE
- K050764 — UNIGLIDE UNICONDYLAR KNEE PROSTHESIS
- K050896 — H12+ HOLTER RECORDER
- K052045 — ACCESS BREAST COIL
- K052052 — HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5
- K052132 — MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
- K052194 — SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
- K050906 — VITALCARE I.V. ADMINISTRATION SET
- K051376 — ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
- K051567 — APTUS TITANIUM OSTEOSYNTHESIS SYSTEM
- K051666 — GAV - GENERAL ANAESTHETIC VAPORIZER
- K051785 — FORMULA 418 BILIARY STENT
- K051862 — PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR.
- K052145 — DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES
- K052180 — MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
- K052188 — CUTANEOUS ELECTRODE
- K052236 — BARD ATLAS PTA BALLOON DILATATION CATHETER
- K033863 — OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03
- K050827 — NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)
- K051236 — RESORB-X SF
- K051427 — GC FUJI FIL LC
- K051445 — MILLIKEN SILVER WOUND DRESSINGS
- K051564 — OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH
- K051642 — FR.O.H. CALCANEUS REPAIR SYSTEM
- K051841 — WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
- K051853 — CARDIOSTREAM SONOAIM
- K051860 — FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
- K051946 — MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM
- K051947 — RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE
- K051995 — PROFEMUR RENAISSANCE HIP STEM
- K051999 — BISCOVER LED
- K052002 — IRON STANDARD
- K052058 — MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL
- K052065 — ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES
- K052187 — MODIFICATION TO: CD HORIZON SPINAL SYSTEM
- K052246 — MODIFICATION TO EN-BLOC BIOPSY SYSTEM
- K050851 — DELTA PUNCTUM PLUG
- K051273 — DIVAS DUAL PLEASURE MALE LATEX CONDOM
- K051348 — CONSERVE TOTAL FEMORAL HEAD
- K051643 — STERRAD STERILIZER CYCLESURE TEST PACK
- K051690 — VYGON NUTRILINE CATHETERS
- K051863 — AMLUCK, YA HORNG
- K051920 — VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001
- K051960 — CARDIONAVIGATOR +
- K051980 — DVT SCANNER
- K052082 — FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
- K052200 — TEM 3000 HEAD COIL
- K043075 — TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
- K043465 — 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011
- K050969 — INCLOSE SURGICAL MESH SYSTEM
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