FDA 510(k) clearances — page 480
clearances on record, most recent first.
Clearances — page 480
47,901–48,000 of 175,770- K103763 — STELLAR 300
- K110343 — TOMMEE TIPPEE CLOSER TO NATURE ELECTRIC BREAST PUMP
- K110389 — STEALTH 360 ORBITAL PAD SYSTEM
- K110511 — E4D COMPASS
- K092433 — DYSIS
- K093736 — DEPUY CORAIL HIP SYSTEM, REVISION STEM
- K102704 — EASY CUFF
- K103053 — VERIFY 270FP CHALLENGE PACK
- K103123 — APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)
- K103479 — NOVEL TAPERED HIP STEM
- K103537 — ET III SA ULTRA WIDE SYSTEM
- K103709 — CERACELL DENTAL
- K110503 — AIRSTRIP REMOTE PATIENT MONITORING (RPM)
- K103518 — TRINITY ACETABULAR SYSTEM
- K103649 — VOLUSON S6, VOLUSON S8
- K101901 — IPL THERAPY SYSTEM
- K103191 — QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
- K110361 — ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
- K100370 — SYMMETRIC TOTAL KNEE AGUMENTS
- K100928 — MICRO DIARY SPIROMETER
- K101250 — GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES
- K101790 — QUANTUM SPINAL SYSTEM, QUANTUM MIS
- K101854 — ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
- K101985 — ASAHI GUIDE WIRE EXTENSION 165CM
- K102064 — BD FACS SAMPLE PREP ASSISTANT III (SPA III)
- K102574 — PALLA M SPINAL SYSTEM
- K102964 — EU-TTG IGA AND EU-TTG IGG
- K103169 — ALEUTTIAN
- K103335 — GEM OPTION FOR 1.5 MRI SYSTEMS
- K103400 — FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP
- K103480 — THORACIC VCAR
- K092622 — STERRAD 100NX STERILIZER EXPRESS CYCLE
- K093584 — EZ-MISTER
- K102229 — PULMOTRACK 2020 SYSTEM
- K102320 — COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)
- K102464 — QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
- K102474 — FLAATZ 750E
- K102610 — FOCUS EMG DEVICE
- K102642 — SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO
- K103127 — SOMATOM DEFINITION AS
- K103206 — RAUMEDIC- ICP-MONITORING SYSTEM
- K103292 — TRIO TRAUMA SPINAL SYSTEM
- K103458 — VIEWPOINT 6
- K103497 — CERAMIC FEMORAL HEAD
- K103585 — BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP
- K103682 — PARIETEX PROGRIP
- K103687 — SYNAPSE 3D CEREBRAL ANALYSIS
- K103792 — BARCO MAMMO TOMOSYNTHESIS
- K110145 — BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
- K110322 — OLECRA INTRAMEDULLARY FIXATION SYSTEM
- K110354 — 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
- K110393 — EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W
- K093830 — MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
- K101820 — NON-STERILE, BLUE & WHITE POWDERED NITRILE EXAMINATION GLOVES
- K102019 — RESTORATION ACETABULAR WEDGE AUGMENTS
- K102403 — SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
- K102554 — AVITA SCANEO IR THERMOMETER MODEL TS4X SERIES
- K102580 — VANGUARD REMOVABLE MOLDED POLY TIBIA
- K102636 — ZENITH PEDICLE SYSTEM
- K102912 — INTERLOCK FIBERED IDC OCCLUSION SYSTEM
- K103126 — TROPHON CHEMICAL INDICATOR
- K103142 — SPACELABS MULTI-PARAMETER MODULE
- K103477 — PERMOBIL M300 / M400
- K103679 — AXIS PACS, HMS PACS
- K103750 — NUVASIVE TRAVERSE PLATE SYSTEM
- K110295 — INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
- K101850 — SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
- K102825 — BLOOD PRESSURE CUFF
- K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
- K103488 — CONCORDE BULLET CAGE SYSTEM
- K103613 — INPECTRA STO2 SPOT CHECK
- K103741 — SURGISURE TISSUE REMOVAL SYSTEM
- K103748 — LAGUNA PEDICLE SCREW SYSTEM
- K110065 — SPAULDING IQ ELECTROCARDIOGRAPH
- K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
- K091010 — TROKAMED MORCELLATOR
- K092275 — RANDOX ECSTASY (MDMA) ASSAY
- K101569 — V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
- K101876 — DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010
- K102172 — MSA HIP SYSTEM
- K103167 — STELLAR 150
- K103647 — THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
- K102397 — KYPHON XPEDE BONE CEMENT
- K103120 — CORIN BIOLOX DELTA FEMORAL HEADS
- K103399 — GENERAL DENISTRY MOTOR
- K103660 — LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
- K103840 — CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE
- K110047 — VERTICOR K-WIRE SYSTEM
- K110362 — VANGUARD ASYMMETRICAL PATELLAR COMPONENT
- K092755 — STERRAAD 100NX EXPRESS CYCLE TEST PACK
- K093884 — ROCHE FLUDI METHAMPHETAMINE
- K100799 — FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
- K100954 — ADAPT, MODEL AX-03SN
- K102223 — CHALLENGE-EVER
- K102375 — LUCIA
- K102482 — FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM
- K102532 — HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
- K102947 — NON-CONTACT INFRARED THERMOMETER
- K103004 — SNORE GUARD
- K103185 — TOSHIBA 1.5T EXTRA LARGE KNEE COIL
Data sourced from openFDA. This site is unofficial and independent of the FDA.