FDA 510(k) clearances — page 404
clearances on record, most recent first.
Clearances — page 404
40,301–40,400 of 176,542- 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
- K130322 — SPM-300
- K130368 — AUTOLITH TOUCH; URO TOUCH
- K130569 — ND NABIL DIB INFUSION CATHETER
- K130689 — SYMPHONY RF GENERATOR
- K130997 — NEOVEIL
- K131672 — MICROCYN SCAR MANAGEMENT HYDROGEL
- K131850 — TENSYN BAND
- K131921 — ELECTRONIC PULSE STIMULATOR
- K132376 — DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T
- K132507 — VITEK 2 AST ST MEROPENEM
- K132542 — TRANSGATE GUIDE CATHETER
- K132741 — V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- K132951 — MAGNETOM AERA
- K133031 — SHARPSOLOGY 2
- K133140 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
- K133142 — VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION
- K130829 — IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS
- K131026 — BOSCH BLOOD PRESSURE METER (BP5000 BT)
- K131165 — ANKER DENTAL IMPLANT SYSTEM
- K131262 — DIGITAL ELECTROCARDIOGRAPHS
- K131284 — GSP NEONATAL BIOTINIDASE KIT
- K131753 — MERIDIAN
- K131778 — FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT
- K132527 — DIGITAL COLOR DOPPLER ULTASOUND SYSTEM
- K132605 — DOSIMETRY CHECK VERSION 4 RELEASE 1
- K132614 — PEREGRINE CURVED ILLUMINATING LASER PROBE
- K133208 — INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
- K122252 — SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS
Data sourced from openFDA. This site is unofficial and independent of the FDA.