FDA 510(k) clearances — page 408
clearances on record, most recent first.
Clearances — page 408
40,701–40,800 of 175,770- K122424 — ISUS IMPLANT SUPRASTRUCTURES
- K123234 — ERMIS STERILIZATION CONTAINER SYSTEM
- K123471 — ETII SA FIXTURE SYSTEM
- K130211 — AIRVIEW BOWIE DICK; TEST PACK, INDICATOR SHEETS
- K130404 — TIBURON SURGICAL DRAPE
- K130473 — NITRILE POWDER FREE EXAMINATION GLOVE (ABLU)
- K131078 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
- K131123 — CLICKFINE AUTOPROTECT PEN NEEDLE
- K131125 — CLICKFINE PEN NEEDLE
- K131283 — PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES
- K131511 — DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR
- K131599 — QUICK VUE INFLUENZA
- K131606 — SOFIA INFLUENZA A+B FIA
- K131666 — ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
- K131671 — MECTALIF
- K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
- K123074 — IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
- K123171 — ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
- K123177 — STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM
- K123256 — HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
- K123641 — CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
- K123983 — FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERS
- K124035 — 2008K@HOME HEMODIALYSIS MACHINE
- K130376 — DYNASTY ACETABULAR SYSTEM WITH CERAMIC
- K130442 — NEWTOM VGI AND NEWTOM 5G
- K130553 — ABSOCLEAR
- K130656 — IFUSION
- K130805 — MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
- K131081 — CYBER TM FAMILY
- K131090 — 2MP COLOR LCD MONITOR, RADIFORCE MX215
- K131106 — DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,
- K131474 — ARTHREX DISTAL RADIUS PLATE SYSTEM
- K131480 — EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
- K131573 — CP150 ELECTROCARDIOGRAPH
- K131575 — EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT
- K131670 — LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
- K131786 — AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
- K122652 — ARTHROCARE TURBINATOR WAND
- K123803 — REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM
- K130256 — MDK MULTI-APPLICATIONS PLATFORM
- K130350 — PROCELLERA
- K130919 — SENSUS
- K130920 — CORRECT PLUS 1
- K130935 — DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
- K131002 — VIDA PTV DILATATON CATHETER
- K131035 — Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM
- K131238 — AFFIX SPINOUS PROCESS PLATE SYSTEM
- K131372 — MOBIS II
- K131401 — BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
- K122202 — ELLEX 2RT
- K124030 — COOK HOLMIUM LASER FIBER
- K130300 — HEATER-COOLER UNIT HCU 40
- K130353 — PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
- K130408 — ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENT
- K131705 — ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
- K131743 — CIRONA DVT FOOT GARMENT
- K122917 — CODA BALLOON CATHETER
- K123275 — IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM
- K123354 — REVITIVE IX
- K123427 — NIRVANA D PERSONAL LUBRICANT (TBD)
- K123559 — SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM
- K123598 — SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
- K123627 — ET SMARTFIT ABUTMENT
- K130002 — SURECALL LABOR MONITOR
- K130638 — ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
- K130724 — CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
- K130808 — STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
- K131509 — ZOE FLUID STATUS MONITOR
- K131568 — SUDO PATH
- K131619 — QUICKVUE INFLUENZA A+B
- K121920 — LASERBRUSH
- K123404 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)
- K130094 — FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
- K130438 — AXLE INTERSPINOUS FUSION SYSTEM
- K130790 — LYRIC2
- K131100 — STREAMLINE TL SPINAL SYSTEM
- K131141 — EARPROBE
- K131589 — KEELER SLIT LAMP H-SERIES
- K131654 — STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER
- K131683 — HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
- K122653 — MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
- K122983 — KSEA BIPOLAR ELECTRODE
- K122997 — 23GA CURVED ILLUMINATING LASER PROBE
- K123266 — BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GN
- K123288 — HEMOCONCENTRATOR
- K130549 — INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
- K130584 — MONITOR B40
- K131556 — DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
- K121481 — INFINI RADIOFREQUENCY SYSTEM
- K121628 — EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
- K122503 — PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
- K130008 — DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING
- K130487 — FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE
- K130850 — PRIMI AND SECONDI SUPPORT CATHETERS
- K131005 — EBA2 FEMORAL NAILING SYSTEM
- K131181 — OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
- K131314 — DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
- K131373 — SHANGRING
- K131489 — TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION
- K123842 — LAWMAX DILATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.