FDA 510(k) clearances — page 406
clearances on record, most recent first.
Clearances — page 406
40,501–40,600 of 175,770- K130109 — ENDOGRAPH DC
- K130140 — INTRA-LOCK OP DENTAL IMPLANT
- K130345 — AQUA LUBE NATURAL LUBRICANT - REGULAR, WARMING
- K130814 — RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
- K130826 — PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER
- K131079 — CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
- K131305 — CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
- K123908 — OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES
- K130144 — ABL90 FLEX
- K130181 — GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
- K130923 — 5F DIGNITY CT TITANIUM PORT
- K131729 — JBAIDS PLAGUE DETECTION KIT
- K131754 — WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
- K131936 — JBAIDS TULAREMIA DETECTION KIT
- K131942 — NMI PICC III CATHETER, NMI HPICC III CATHETER
- K132040 — VIAL CONNECTOR 13MM CLOSED COLLAR
- K132041 — REXTAR X
- K132043 — ARTHREX SPEEDCINCH
- K122458 — VERIZON WIRELESS REMOTE HEALTH MANAGEMENT SYSTEM
- K122532 — DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES
- K124000 — MEDAPPS 2.0 - REMOTE PATIENT MONITORING SYSTEM
- K130302 — SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
- K130621 — BROADMASTER HEALTHCARE SYSTEM
- K130949 — CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS
- K131150 — CURA COMPENSATOR
- K131449 — COALITION SPACER
- K131955 — NEUROBLATE(TM) SYSTEM
- K132008 — 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
- DEN130010 — VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
- K122091 — COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
- K123831 — OPHTACATH KIT
- K130059 — ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
- K130381 — ANGIOJET ULTRA POWER PULSE KIT
- K130855 — PTFE SUPER SHEATH INTRODUCER
- K131182 — MULTIFIX S KNOTLESS FIXATION DEVICE
- K131361 — WARMTOUCH SURGICAL ACCESS BLANKET, WARMTOUCH TORSO BLANKET
- K131710 — MERIT HYDROPHILIC GUIDE WIRE
- K121445 — TETRACHROME REAGENTS AND TETRACXP SYSTEM
- K122659 — VDRIVE W/V-SONO
- K123721 — GMK REVISION EXTENSION
- K123768 — RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM
- K130331 — SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
- K130410 — DENTAL UNIT WITH CHAIR
- K130478 — SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
- K130500 — CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT
- K130623 — BARRX CHANNEL RFA ENDOSCOPIC CATHETER
- K130680 — ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
- K130785 — SEER 1000
- K131117 — ZIRMON SERIES
- K131264 — KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWS
- K131448 — 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION
- K131549 — CHEMOLOCK, CHEMOLOCK PORT
- K131595 — EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
- K131814 — AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
- K131931 — CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST
- K131999 — HBA1C CONTROL, LEVEL 1 AND LEVEL 2
- DEN130032 — XPERT MTB/RIF ASSAY
- K123027 — CAPSTONE(R) SPINAL SYSTEM
- K130001 — CARE SU01A SUCTION ASPIRATOR
- K130158 — M-SCAN
- K130431 — COMPRESSYN BAND
- K130706 — DUOFLEX COIL SUITE (1.5T)
- K130859 — HAMMERTOE CORRECTION SYSTEM
- K131159 — SMARTRELIEF
- K131475 — BARRICADE EMBOLIZATION COIL SYSTEM
- K131498 — IQQA-LIVER MULTIMODALITY SOFTWARE
- K131620 — JONES-FX FRACTURE SYSTEM
- K131812 — SENSIS, SENSIS LITE
- K131974 — HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
- K123714 — EDWARDS EMBOL-X INTRODUCER SHEATH
- K130125 — MTA CEMENTS
- K130305 — LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE
- K130667 — POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL
- K130962 — R&D 5D RETIC HEMATOLOGY CONTROL
- K131263 — XPERGUIDE
- K131343 — REFORM PEDICLE SCREW SYSTEM
- K131542 — NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC
- K131561 — SAM JUNCTIONAL TOURNIQUET
- K131690 — M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
- K131742 — HEM-6131
- K131964 — BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
- K132087 — PERCUNAV SYSTEM
- K123631 — MFP-051
- K123807 — SHARPSCAN
- K130207 — SPACELABS HEALTHCARE CARDIOEXPRESS
- K130648 — FORUM GLAUCOMA WORKPLACE
- K130702 — AIRSONETT AIR-4
- K130740 — NIGHTINGALE MONITORING SYSTEM
- K130862 — CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM
- K130986 — FRAG-LOC SYSTEM
- K131816 — SORIN CONNECT DATA MANAGEMENT SYSTEM
- K131822 — ULTRAEXTEND USWS-900A V2.1 AND V3.1
- K132062 — ESIE APPS SUITE
- K130220 — MR CONDITIONAL PRESSON ELECTRODE
- K130750 — RHYTHMIA MAPPING SYSTEM
- K131191 — 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS
- K131306 — IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE
- K131572 — MICRO AMBULATORY ECG RECORDER
- K123418 — GRAM-NEGATIVE QUICKFISH BC
- K120510 — TRANSCEND
Data sourced from openFDA. This site is unofficial and independent of the FDA.