FDA 510(k) clearances — page 513
clearances on record, most recent first.
Clearances — page 513
51,201–51,300 of 175,825- K092257 — JALOSKIN
- K092845 — RESPISENS
- K093070 — DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES
- K093363 — COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
- K093681 — MERIDIAN GUIDEWIRE
- K100076 — ATRIUM C-QUR OVT MESH
- K091717 — ANY PLUS SPINAL FIXATION SYSTEM
- K092106 — U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132
- K092224 — TIGR SURGICAL MESH , MODEL WK-6
- K093364 — SOLO MICROPUMP INSULIN DELIVERY SYSTEM
- K093464 — RAPIDSORB PLUS SCREW SYSTEM
- K094020 — GRIND NO MORE GENERATION II
- K094036 — TURBO-TANDEM SYSTEM MODEL 472-110
- K091328 — SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
- K091387 — BTI DENTAL IMPLANT 5.5-6.5
- K092098 — PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
- K092360 — ACP4 SPINAL IMPLANT SYSTEM
- K092684 — LAPAROSCOPIC RETRACTORS
- K092818 — BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
- K093080 — METAPHOR METABOLIC MONITOR
- K093162 — FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID
- K093185 — OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
- K093781 — MODIFIED: NEWDEAL HALLU PLATES
- K093823 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM
- K093950 — BIOFOAM BONE WEDGE MODEL ASSORTED
- K093968 — OSV II LOW FLOW LOW PRO VALVE
- K093985 — NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE
- K093986 — AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
- K090953 — TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
- K091425 — QUANTUM M COMPOSITE NAILING SYSTEM
- K091863 — AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS
- K092096 — ENDOFORM DERMAL TEMPLATE
- K092124 — AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II
- K092250 — MEDLINE RED RUBBER URETHRAL CATHETER
- K092263 — ENDURAVENT-5 VENTILATOR
- K092388 — DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
- K093075 — ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT
- K093092 — ODYSSEY WORKSTATION
- K093195 — ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
- K093217 — 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
- K093370 — FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
- K093427 — FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR
- K093587 — DENTAL MERCURY
- K093911 — FOGARTY OCCLUSION CATHETER
- K093918 — JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE)
- K093919 — MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
- K093944 — MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S
- K093947 — ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
- K093972 — BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706
- K082805 — PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX
- K092110 — WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
- K093022 — THE PICC WAND PEELABLE SAFETY INTRODUCER
- K093065 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
- K093172 — QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)
- K093593 — CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO
- K091765 — EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
- K091936 — BLADE ANTERIOR CERVICAL PLATE SYSTEM
- K092655 — C. ALBICANS PNA FISH
- K092754 — SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061
- K092978 — IMMUNOCAP RAPID READER, MODEL 12-3600-10
- K093200 — LIFE SPINE LUMBAR PLATE SYSTEM
- K093445 — KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)
- K093500 — POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE
- K093693 — NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH
- K093703 — 3DI
- K093713 — ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM
- K093849 — ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
- K093923 — CEROX MODEL 3210
- K091052 — PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
- K091259 — ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
- K091511 — MODERN MEDICAL RESECTOSCOPE ELECTRODES
- K091547 — NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
- K091674 — ARTHROCARE COBLATOR IQ SYSTEM
- K091950 — SMART-WELL EZTEST INCUBATOR
- K092743 — THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
- K092878 — PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE
- K093223 — COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG
- K093358 — MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
- K093657 — ADAGIO RETRACTING ECG LEAD WIRES
- K093855 — HALO 360 & SIZING BALLOON, MODEL 3441C
- K093882 — SORIN C5 SYSTEM MODEL 58-00-00
- K093970 — PICA CATHETER
- K082275 — CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023
- K083811 — W&H HANDPIECE ANESTO, MODEL: RA-5
- K090271 — HYDROCOAT MESH
- K091867 — ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
- K092047 — ASCENSION METAL GREAT TOE SYSTEM
- K092158 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K092627 — CT2011 SONICSTIMU PAIN RELIEF DEVICE
- K092831 — DISPOSABLE HYPODERMIC NEEDLE
- K092893 — TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES
- K092933 — SAF (SELF ADJUSTING FILE)
- K093231 — ALBOGRAFT VASCULAR PROSTHESIS
- K093308 — MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
- K093518 — ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
- K093519 — MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET
- K093658 — RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS
- K093659 — ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
- K093730 — PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)
- K092118 — ANGIOGRAPHIC CATHETER, MODEL ANGIOS
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