FDA 510(k) clearances — page 522
clearances on record, most recent first.
Clearances — page 522
52,101–52,200 of 175,825- K092666 — INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
- K083157 — HS AMICA
- K083378 — SYNERGY
- K090117 — AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET
- K090353 — PERIMETER INTERBODY FUSION DEVICE
- K091014 — JOURNEY BCS KNEE SYSTEM
- K091637 — CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
- K092020 — AADVA ZR COLORING LIQUID
- K092278 — GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4
- K092851 — MODEL GDCH-2000
- K083840 — MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
- K090387 — KAINOS+
- K090557 — GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
- K091218 — DBX DEMINERALIZED BONE MATRIX PUTTY
- K091228 — SPINEWAND SURGICAL DEVICE
- K091246 — ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M)
- K091697 — SPIDER SURGICAL INSTRUMENTS, MODELS 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015
- K091828 — SHEATHESISO ULTRASOUND TRANSDUCER COVER
- K091919 — DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST
- K091920 — ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL
- K091947 — S8 ASPEN WITH H4I PLUS
- K091981 — LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
- K091998 — ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
- K092715 — IROOT BP PLUS
- K092756 — GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM
- K082648 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K083597 — SONOWAND INVITE
- K083868 — ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
- K090183 — HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
- K090193 — CONDUCTOR CORONARY GUIDEWIRE
- K090652 — ALPHA DUO LAP INSUFFLATOR
- K090757 — BIOMET MODULAR FEMORAL REVISION SYSTEM
- K091213 — FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN
- K091214 — FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER
- K091280 — FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT
- K091411 — KNEEALIGN SYSTEM
- K091601 — ELECYS ANTI-CCP CALCHECK
- K091735 — DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT
- K091825 — HI-TORQUE PROGRESS GUIDE WIRE FAMILY
- K091826 — ELEGANT
- K091904 — NOBELPROCERA ZI ABUTMENT
- K091946 — VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX
- K092012 — PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
- K092193 — SPINAL USA INTERBODY CAGES
- K092247 — SYNTHES LOCKING HAND PLATES
- K092248 — SPI CUSTOMIZABLE GINGIVA FORMER
- K092415 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K092621 — PASCAL STREAMLINE PHOTOCOAGULATOR
- K092624 — FIREBIRD SPINAL FIXATION SYSTEM
- K092626 — MODIFICATION TO: EXPEDIUM SPINE SYSTEM
- K092629 — SNM FIRMGRIP
- K092631 — MANTIS REDUX SPINAL SYSTEM
- K092633 — OSOM INFLUENZA A&B TEST , MODEL PN190
- K092646 — SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW
- K092683 — DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
- K090932 — NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE - 200CM, MODEL MRD-1000; 80 CM, MODEL MRD-2000
- K091964 — CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
- K092059 — RP CUTTING NEEDLE
- K092132 — XIO RTP SYSTEM
- K092610 — MODIFICATION TO BEACON STABILIZATION SYSTEM
- K092637 — PACSCAN PLUS, MODELS 300P AND 300AP
- K090339 — BELIMED STEAM STERILIZER TOP 5000, SERIES 8, MODELS: 6-0-12 VS1 AND VS2
- K090989 — ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES
- K091060 — VESOCCLUDE LIGATING CLIP
- K091800 — LIPOEZE LASER ASSISTED ASPIRATION CANNULA
- K091818 — LAURIMED SPINAL INJECTION SYSTEM
- K091930 — ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB
- K091972 — MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-01
- K092038 — APTUS K-WIRE SYSTEM
- K092671 — VARIAX ELBOW SYSTEM LINE EXTENSION
- K092680 — DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN
- K091239 — ASTRA TECH IMPLANT SYSTEM
- K091343 — MRI NEURO DRAPE
- K091572 — DISPOSABLE SPO2 SENSOR M1134A
- K091756 — NOBELPROCERA TI ABUTMENT
- K091980 — ACL TOP 700 LAS
- K092083 — EXTEND FRAME SYSTEM, MODEL 1009633
- K092143 — EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
- K092495 — HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315
- K092742 — NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
- K090718 — BELLUS SHADING KIT
- K090752 — PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
- K090863 — PERSONAL WHEEZOMETER
- K091220 — HEALTHANYWHERE SYSTEM
- K091553 — BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE
- K091647 — INJECTAFIL
- K091853 — WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
- K091870 — TORNIER, PITON FIXATION IMPLANT SYSTEM
- K091883 — T2 SPINAL SYSTEM
- K091942 — POWDER-FREE, VINYL PATIENT EXAMINATION GLOVES
- K092051 — THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
- K092130 — RASCAL WE GO 250 POWERED WHEELCHAIR
- K092154 — HEARTWAY POWER MOBILITY SCOOTER, S9
- K092155 — HEARTWAY POWER MOBILITY SCOOTER, S8
- K092327 — MICRO-TOUCH NITRA FREE
- K092758 — X-CUBE
- K082118 — XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
- K090216 — COLLAGEN DENTAL MEMBRANE IV
- K090429 — NUNC IVF CENTERWELL AND ICSI DISHES
- K090449 — MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT
Data sourced from openFDA. This site is unofficial and independent of the FDA.