FDA 510(k) clearances — page 399
clearances on record, most recent first.
Clearances — page 399
39,801–39,900 of 175,770- K132494 — VISCOELASTIC INJECTOR
- K132673 — 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER
- K132727 — GEM FLOW COUPLER DEVICE AND SYSTEM
- K132751 — MULTICHEM S PLUS / S PLUS (ASSAYED)
- K132990 — OCCLUSION BALLOON CATHETER
- K133128 — IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION
- K130198 — NEO DENTA ZIRCONIA
- K130528 — BIOPLEX 2200 APLS IGM
- K131630 — PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
- K132013 — SWIFT AIR
- K132181 — GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
- K122437 — NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
- K122848 — LENSTEC LC INJECTION SYSTEM
- K130213 — QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE
- K130504 — ASA ORAL APPLIANCES
- K130684 — PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
- K131214 — CRANIAL MAP NEURO
- K131663 — ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
- K131859 — MULTIFUNCTIONAL SERIES
- K131947 — PROVOX VEGA PUNCTURE SET
- K131982 — REMSTAR AUTO A-FLEX HT
- K132096 — RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR
- K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
- K132947 — DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
- K123049 — SAPPHIRE INFUSION PUMP
- K124041 — NBM-200MP
- K130378 — RESPIGUIDE DELIVERY SYSTEM
- K130601 — BIOROOT RCS
- K130719 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
- K130942 — LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF
- K130958 — TRUE SPINAL FIXATION SYSTEM
- K131013 — FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
- K131167 — UNIVATION
- K131459 — AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
- K131775 — UNIVERSAL NEURO 3 SYSTEM
- K131872 — INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
- K131994 — SOMNOLYZER 24X7
- K132127 — TRANSCEND AUTO
- K132251 — APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)
- K132272 — GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
- K132430 — STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER
- K132438 — IMAGENET 5 PC SOFTWARE SYSTEM
- K132468 — MRSA/SA ELITE MGB, ELITE MGB SOFTWARE
- K132612 — HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE
- K132636 — DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM
- K132942 — SITE-RITE VISION II ULTRASOUND SYSTEM
- K122949 — MEDLINE SUCTION COAGULATOR
- K130254 — PROW FUSION
- K130294 — BRAEMAR CARDIOKEY HOLTER RECORDER
- K130644 — PEDIATRIC FOLDING WHEELCHAIR
- K130686 — NASAL COMFORT FREEDOM
- K131022 — OVATION 10/12 HIP STEM
- K131047 — FINGERTIP PULSE OXIMETER
- K131231 — AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
- K131405 — IFUSE IMPLANT SYSTEM
- K131640 — SMOOTH OR THREADED METALLIC BONE FASTENER
- K132160 — VANTAGE TITAN 3T
- K132236 — .DECIMAL PROTON APERTURE
- K132461 — A.I.M. SUTURE ANCHOR
- K132664 — ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
- K130231 — NON-CONTACT INFRARED THERMOMETER
- K131234 — LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
- K131991 — ENDOCHOICE HOT BIOPSY FORCEPS
- K131993 — MULTICHEM U
- K130123 — BASIC AND DOMINANT FLEX SUCTION PUMPS
- K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR)
- K130858 — REVERSE MEDICAL MICROCATHETER
- K130881 — ACUSON S2000 AND S3000
- K131023 — THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
- K131337 — BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA
- K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
- K131437 — MODIFIED CONCENTRIC MICROCATHETER
- K131502 — SEATTLE - PAP
- K131534 — KATANA ZIRCONIA
- K131677 — PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
- K131807 — HIGH ENERGY LINEAR ACCELERATOR
- K131908 — 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
- K132145 — MTM(R) CLEAR ALIGNER
- K132161 — OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS
- K132235 — IMDX C.DIFFICILE FOR ABBOTT M2000
- K132405 — PPA/BT-RB STETHOSCOPE
- K132560 — PCP-USB STETHOSCOPE
- K132619 — CLASSIC INTERMITTENT CATHETER
- K132885 — TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
- K130728 — POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
- K131178 — IDYS LIF CAGES
- K131365 — T2 TIBIAL NAILING SYSTEM
- K131422 — PEERSCOPE SYSTEM
- K131636 — POLARUS CONNECT
- K131662 — IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
- K131684 — BIOLOX(R) DELTA CERAMIC HEADS
- K131739 — NXSTAGE CONNECTED HEALTH SYSTEM
- K131779 — VITEK 2 AST-ST TIGECYCLINE
- K131797 — 3B LASER NEEDLE
- K132139 — DELTEX MEDICAL CARDIOQ-EDM+
- K132303 — IMPLANET SPINE SYSTEM
- K132412 — INERTIA MIS PEDICLE SCREW SYSTEM
- K132482 — BARRICADE EMBOLIZATION COIL SYSTEM
- K123205 — ESOPHAGEAL TTS STENT
- K130379 — ROLLINS 7 OXYGEN MASK
Data sourced from openFDA. This site is unofficial and independent of the FDA.