FDA 510(k) clearances — page 695
clearances on record, most recent first.
Clearances — page 695
69,401–69,500 of 176,637- K040721 — ASSURE ANTERIOR CERVICAL PLATE SYSTEM
- K040747 — ALADYN RIGID SPINE PLATE
- K040749 — MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
- K040755 — EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
- K040837 — MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
- K040847 — MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
- K040860 — INTEGRA BONE FIXATION SYSTEM
- K040864 — CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM
- K041022 — NEUROQ - PET DP
- K041094 — HSG CATHETER SET
- K041165 — FSH MENOPAUSE PREDICTOR TEST
- K041200 — THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000
- K041229 — MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)
- K041322 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
- K041339 — AEQUALIS SHOULDER SYSTEM
- K041476 — GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
- K041487 — QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT
- K041542 — CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS
- K033896 — DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P
- K040030 — BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114
- K040332 — POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
- K040379 — RANDOX IMMUNOASSAY CONTROL
- K040443 — DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I
- K040906 — CALIBRA CEMENT
- K040967 — DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES
- K041040 — VARELISA MPO ANCA, MODEL 17648/17696
- K041141 — DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
- K041158 — ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
- K041335 — PTM SYSTEM
- K041343 — XENO NM LIGHT CURED DENTAL ADHESIVE
- K041402 — MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS
- K041448 — HEXAPOD RT COUCHTOP
- K030831 — LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS
- K032327 — MODERN MEDICAL BIPOLAR FORCEPS
- K033960 — OLINDA/EXM
- K040617 — RELIANT LASER SYSTEM II
- K040701 — SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
- K040835 — PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16
- K040900 — S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K040943 — MEDTRONIC PS MEDICAL STRATA VALVE
- K041023 — STAY-PUT IMPREGNATED
- K041050 — DIGORA OPTIME (OR DIGORA ONTIME)
- K041220 — GE DISCOVERY ST SYSTEM
- K041331 — BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER
- K040257 — QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
- K040425 — ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
- K040680 — CONTOUR HA COATED RECONSTRUCTION RING
- K040956 — HILUX LEDMAX 3
- K041305 — STRYKER BIOZIP SUTURE ANCHOR SYSTEM
- K041307 — MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
- K041310 — STRYKER WEDGE SUTURE ANCHOR SYSTEM
- K041383 — STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230
- K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S
- K033477 — HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
- K033552 — JAX-TCP
- K040657 — BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80
- K040675 — AXIOM ARTIS U
- K040689 — EYE SPHERE IMPLANTS
- K040697 — 21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)
- K040723 — MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
- K040753 — R-TEST EVOLUTION 3
- K040794 — INCUBATOR CAPE
- K040836 — DISPOSABLE OVERTUBE
- K040882 — VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
- K040926 — ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000
- K040941 — CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
- K041130 — CDS HEMATOLOGY CALIBRATOR (CDS CAL)
- K041234 — HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
- K041282 — MODIFICATION TO TSRH SPINAL SYSTEM
- K041288 — MODIFICATION TO SMARTPIN
- K041296 — MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
- K041306 — NUMED PTS X SIZING BALLOON CATHETER
- K041315 — CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
- K041418 — AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
- K041455 — SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
- K041499 — SSA-770A, APLIO VERSION 5.5
- K033884 — RANDOX AMIKACIN
- K040220 — MEDICAL AIR COMPRESSOR
- K040484 — MAXO2+, MODEL A AND AE
- K040661 — RADENT PROPHY PASTE
- K040807 — MIS DENTAL IMPLANT SYSTEM
- K041035 — HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND
- K041156 — AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001
- K041212 — HOUVA 3 PHOTOTHERAPY SYSTEM
- K041395 — EG-3630UR
- K041396 — FG-36UX FIBER ULTRASOUND GASTROSCOPE
- K041397 — EG-3830UT
- K041444 — BIO-RAD D-10 DUAL PROGRAM
- K040171 — MICRODERM, MODEL/VERSION 3.5
- K040746 — MRA-CMS
- K040813 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
- K040845 — VITEK 2 ESBL TEST
- K040969 — POISE DATAENGINE
- K041041 — NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K041146 — CONTROL SOLUTIONS, INC., MODEL CS3102 HVG
- K041366 — IPACS ORTHO
- K041380 — IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
- K041404 — CLEARBLUE EASY EASY READ PREGNANCY TEST
- K033276 — VPAP III ST-A
- K040048 — FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.