FDA 510(k) clearances — page 475
clearances on record, most recent first.
Clearances — page 475
47,401–47,500 of 176,542- K111974 — ION HEALTH USB INSTA-SCAN THERMOMETER
- K102120 — NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202
- K102330 — AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
- K103448 — BRIVO XR385
- K103699 — EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
- K110486 — ACCUSOM
- K110580 — NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
- K110627 — NEXSITE 9FR DUAL LUMEN CRITICAL CARE CENTRAL VENOUS CATHETER
- K110758 — NITRILE POWDER FREE EXAMINATION GLOVES
- K111053 — SENTRYSUITE PRODUCT LINE
- K111300 — SENSTOUCH NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE (GREEN, ORANGE, VIOLET AND WHITE)
- K111347 — ISROBOT MONA LISA
- K111383 — ZIRPRIME
- K111599 — VITEK 2 AST-ST LINEZOLID
- K111739 — KIDS ROCK 3 CHAIR
- K112034 — TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
- K112103 — INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
- K102516 — LUCINA MODEL MELODI
- K103028 — EEVATM PETRI DISH
- K110348 — UNIVERSAL CLAMP SPINAL FIXATION SYSTEM
- K110663 — PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
- K110719 — ORIGIN ZIRCONIA
- K111108 — PASCAL STREAMLINE 577 (WITH ACCESSORIES)
- K111127 — ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
- K111282 — DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES
- K111338 — WILDCAT CATHETER
- K111632 — INFILL GRAFT DELIVERY SYSTEM
- K111715 — EMBRYOSCOPE
- K111852 — ANODIZED HEALING COLLAR
- K111991 — NIO COLOR 2MP
- K101533 — EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
- K102078 — RADIOLOGICAL IMAGE PROCESSING SYSTEM
- K103619 — SYNTHETIC EXAM GLOVE POWDER FREE COATED WITH ALLOGEL (GREEN/ BLUE / WHITE / MAGENTA / CLEAR - NON COLORED)
- K110137 — ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN
- K110856 — RALCO
- K111158 — LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K111201 — C7 XR IMAGING SYSTEM
- K111437 — SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
- K111963 — BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
- K112180 — I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)
- K100015 — VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34
- K101307 — BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
- K102188 — CYBOW READER, MODELS 300 & 720
- K103657 — SAPPHIRE
- K110293 — OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER
- K110388 — COLLACARE DENTAL
- K110543 — CRESCENT (R) SPINAL SYSTEM TITANIUM
- K111044 — SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPED OBTURATOR; LOW PROFILE DRILL GUIDDE
- K111265 — METASURG SUBTALAR IMPLANT
- K111760 — NAVIAID(TM) BGC DEVICE
- K111047 — CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
- K111199 — INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS
- K111333 — ANTLIA III WOUND TREATMENT SYSTEM
- K111540 — SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM
- K111590 — ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR
- K111779 — Y-KNOT ALL-SUTURE ANCHOR MODEL HF13
- K112059 — T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
- K100967 — PERIMETER C SPINAL SYSTEM
- K101517 — SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
- K110027 — SURGICAL FACE MASK; SURGICAL FACE MASK
- K110204 — BRAINLAB TRAUMA
- K110468 — FREEWAY COMFORT BITE GUARD
- K110813 — HEADWAY 27 MICROCATHETER
- K110959 — ORTHOPEDIATRICS BLADE PLATE SYSTEM
- K111319 — IBIS EXPLORER AND MARKUP SOFTWARE
- K111762 — ST AIA-PACK DHEA-S CALIBRATOR SET
- K111931 — GLIASITE RTS
- K111945 — IMPAX NEXT GENERATION
- K112054 — INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V
- K112135 — ECG-6 SERIES ELECTROCARDIOGRAPH
- K110005 — SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
- K110245 — UNITED UTF STEM
- K110410 — MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
- K111043 — ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
- K111122 — AESCULAP SIBD XP SPINAL SYSTEM
- K111372 — TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID (TM) DUAL LUMEN CATHETER, PALINDROME (TM)...
- K111387 — LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
- K111478 — STRYKER SPINE POWER ADAPTOR (ACCESSORY INSTRUMENT)
- K111677 — MICROSCAN(R) MICROSTREP PLUS(R)
- K111911 — CORIN OPTIMOM MODULAR HEAD
- K101934 — DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000
- K102760 — ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001
- K103796 — TELEMEDCARE HEALTH MONITOR
- K110350 — KNEEHAB XP
- K110707 — CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
- K110735 — TANDA MAX OTC SYSTEM
- K111095 — BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025
- K111195 — VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
- K111376 — CONSTRUX EXTERNAL FIXATION DEVICE
- K111527 — MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
- K111705 — EKOSONIC ENDOVASCULAR SYSTEM
- K112072 — ATRICURE CRYO MODULE SYSTEM
- K102158 — SIGMA STERILIZATION POUCH & ROLL
- K102489 — VANTAGE TITAN 3T
- K103733 — UNITED U2 XPE TOTAL KNEE SYSTEM
- K103802 — TRUSIGNAL R SPO2 PEDITIP SENSOR (3 models)
- K110679 — DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
- K110801 — WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
- K110858 — LO-BAK TRAX
- K110991 — MESA SPINAL SYSTEM (KEYSTONE RODS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.