FDA 510(k) clearances — page 396
clearances on record, most recent first.
Clearances — page 396
39,501–39,600 of 175,770- K122340 — PRODIGY CHOICE
- K131298 — EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
- K131302 — SOLAX
- K131369 — FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
- K131629 — NEURODYN MULTIWAVE, AUSSIE SPORT
- K131646 — DISPOSABLE INFUSION SET
- K131699 — EMOTION ECG MOBILE
- K131828 — POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR
- K131897 — CV3000 HOLTER ANALYSIS SYSTEM
- K131913 — INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC
- K131997 — NEWTRON BOOSTER
- K131998 — ASPIRE RX-LP6 ASPIRATION CATHETER
- K132170 — SHASER V-MINI RX
- K132372 — STERITEC GREEN CARD PACK BOWIE-DICK TEST
- K132526 — KNIT-PAK+
- K132624 — TRIATHLON TRITANIUM METAL-BACKED PATELLA
- K132699 — AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)
- K132740 — SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
- K132795 — CYBERWAND STERILE PROBE SET
- K132822 — BD MAX STAPHSR ASSAY, INSTRUMENT
- K133330 — C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
- K130135 — DANA REUSABLE BI TEST PACK
- K130777 — INBODY
- K130856 — BIA / VITALITY ANALYZER
- K131339 — CAPNOMASK
- K132029 — VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
- K132101 — ANAX 5.5 SPINAL SYSTEM
- K132217 — ARTHREX COMPRESSION FT SCREWS
- K132498 — VALVED TEARAWAY INTRODUCER GENERATION II
- K132504 — TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
- K132509 — FDR D-EVO FLAT PANEL DETECTOR SYSTEM
- K132544 — TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
- K132597 — BLACK COLOURED CONDOM
- K132639 — CD HORIZON SPINAL SYSTEM
- K132884 — PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
- K133357 — CHARRUAPACS SYSTEM
- K121587 — BREATH SHAKE
- K123090 — GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
- K130199 — CLARITY LPC LASER SYSTEM
- K130515 — VIRTUOSO SYSTEM FOR IHC ER (SPI)
- K130554 — REDSENSE ALARM SYSTEM
- K130730 — V-STICK VASCULAR ACCESS SET
- K131482 — SOFIA DISTAL ACCESS CATHETER
- K131819 — PC ECG
- K131826 — TOPTOUCH /OTHER CLIENTS PRIVATE LABELING
- K132119 — MAGNETOM PRISMA, MAGNETOM PRISMA FIT
- K132189 — OTOMAG BONE CONDUCATION HEARING SYSTEM
- K132191 — SP-FIX SPINOUS PROCESS FIXATION PLATE
- K132288 — CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER
- K132371 — EASYCARE ONLINE
- K132443 — PIEZON 150
- K132588 — ADHESIVE ELECTRODES
- K132728 — V8 TRANSLUMINAL BAV CATHETER
- K132918 — SENSE-4BABY SYSTEM
- K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
- K133216 — CRESCENT SPINAL SYSTEM
- K133284 — ELECSYS CK-MB CALCHECK 5
- K133399 — DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
- K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
- K130514 — AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
- K130831 — MALDI BIOTYPER CA (MBT-CA) SYSTEM
- K132066 — INFLAMMA DRY
- K132306 — PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
- K122438 — HAMILTON-MR1
- K130212 — SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
- K130230 — STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
- K130707 — ISIRONA MAGELLAN
- K131387 — WRIGHT GRADIENT 52 - TORSO
- K131689 — MRI MARKER
- K132168 — BRONCHOSCOPY ELBOW
- K132347 — MULTICAM 3000 ECO
- K132411 — AFFIX II SPINOUS PROCESS PLATE SYSTEM
- K132603 — APEX SPINE SYSTEM
- K132655 — RETROARC RETROPUBIC SLING SYSTEM
- K132757 — EVEREST SPINAL SYSTEM
- K132808 — VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
- K132821 — AGAMATRIX HEALTH MANAGER
- K132847 — I2C
- K132893 — EDGE ORTHOPAEDICS BITE COMPRESSION SCREW
- K132971 — MONACO
- K133008 — BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
- K133264 — NMI PICC III
- DEN130011 — ILLUMINA MISEQDX PLATFORM
- DEN130042 — MISEQDX UNIVERSAL KIT 1.0
- K123148 — PARACE MD EKOSCOPE IS100
- K124006 — ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
- K130426 — SUMITOMO PROTON THERAPY SYSTEM
- K131377 — HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
- K132258 — ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
- K132712 — AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
- K132750 — ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
- K132779 — DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
- K132898 — A.L.P.S. CALCANEAL PLATING SYSTEM
- K133276 — V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS
- K131782 — LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
- K132261 — DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
- K132718 — INTEGRITY SPINE CORE SYSTEM
- K132859 — INTEGRA FACET FIXATION SYSTEM
- K132968 — UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
- K133102 — FLOWER ANKLE PLATING SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.