FDA 510(k) clearances — page 729
clearances on record, most recent first.
Clearances — page 729
72,801–72,900 of 175,825- K021622 — HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
- K022277 — OSTEOMED CRANIAL FLAP FIXATION SYSTEM
- K023794 — CONSTRAINED LINER
- K030027 — GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%
- K030094 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
- K030153 — ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
- K030198 — HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
- K030205 — CONSENSUS UNIPOLAR HEAD, COCR
- K030382 — SELITHERM, MODEL C100
- K030390 — SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
- K030572 — HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE
- K030619 — ODI 7.0MM CANNULATED SCREW SYSTEM
- K030677 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE
- K030740 — MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
- K030918 — SUPEROPEN 0.35T, MODEL NSM-P035
- K030936 — RITA CLIPS FOR INFUSION PUMPS
- K023381 — VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
- K023505 — VBL SERUM TROPONIN I TEST, MODEL 1001
- K023833 — GISH ARTERIAL FILTER WITH GBS COATING
- K024006 — G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
- K024371 — CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
- K030007 — ITI DENTAL IMPLANT SYSTEM
- K030053 — JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810
- K030154 — IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
- K030616 — CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5
- K030653 — SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS
- K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
- K012677 — REPROCESSED PULSE OXIMETER SENSORS
- K022446 — MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
- K022965 — BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
- K023210 — SEEDLINKS, MODELS 70301, 70302, 70303
- K023257 — ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX
- K023565 — OXICHECK
- K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
- K024347 — EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
- K030016 — TEOAE25
- K030073 — VERMED A10021 RESTING EKG TAB ELECTRODE
- K030162 — LAWRENCE CSERION, MODEL CS-1
- K030325 — POWDERFREE LATEX EXAMINATION GLOVES WITH BUBBLEGUM
- K030351 — STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
- K030386 — POWDER FREE SYNTHETIC NITRILE NEOPRENE EXAMINATION GLOVES, SIZES SMALL,MEDIUM, LARGE, AND X-LARGE
- K030571 — ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER
- K030625 — SPINAL CONCEPTS INC. PATHFINDER
- K030635 — THE OBSIDIAN PACS SYSTEM
- K030648 — VECTORSURGE 5 MODEL 470
- K030674 — MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD
- K030688 — ECHELON MICRO CATHETER, MODEL 105-5092-150
- K030825 — MPM-NET
- K030856 — ER800 SERIES ECG EVENT RECORDER
- K030874 — GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM
- K030878 — ACCOUSONIC, MODEL AS-270
- K020189 — EXEL BUTTERFLY SCALP VEIN SET
- K023556 — FLU OIA A/B TEST KIT
- K024334 — QUANTA LITE H.PYLORI IGA ELISA
- K030212 — MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K030363 — ORG@NIZER, MODEL VERSION 3.0
- K030770 — OTI SCAN WITH TRANSDUCERS
- K030859 — NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN
- K023513 — LOGOS JUNIOR DENTAL CHAIR AND UNIT
- K023819 — FIBERFILL SGP
- K023998 — THERIRIDGE BLOCK, BONE GRAFT SUBSTITUTE
- K024240 — BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
- K024261 — DENTAL PROTECTOR
- K024356 — CLEARFIL SILANE KIT
- K030018 — MHS 7000
- K030201 — MODIFICATION TO EXPORT ASPIRATION CATHETER
- K030273 — GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE
- K030312 — PORTA IMPLANT
- K030689 — SPI ELEMENT DENTAL IMPLANT O 3.5 MM
- K030705 — CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL
- K030763 — DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM
- K030789 — AMSCO CENTURY STEAM STERILIZER
- K020271 — LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100
- K023658 — STERILIZATION CASES AND TRAYS
- K023753 — VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E
- K023754 — VINYL EXAMINATION GLOVES, POWDER-FREE WITH VITAMIN E
- K023969 — REACTIVE SKIN DECONTAMINATION LOTION
- K024324 — LATEX CONDOM AND LATEX CONDOM LUBRICATED WITH NONOXYNOL-9
- K024327 — SETPOINT ENDOVASCULAR TEMPERATURE PROBE
- K024358 — 20.1 MONOCHROME LCD MONITOR, RADIFORCE G21
- K030134 — LATEX EXAMINATION GLOVES POWDER FREE WITH NEOPRENE LINED, SIZES XSMALL, SMALL, MEDIUM, LARGE, XLARGE
- K030284 — POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)
- K030317 — MODEL 1300GE-64: PEDIATRIC POSITIONER
- K030577 — PROVEN MODULAR TIBIAL TRAY
- K030601 — VERTE-STACK SPINAL SYSTEM
- K030645 — BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
- K030658 — STANDARD THERMOMETER
- K030665 — BONE WIRE
- K030666 — MULTICARE PLATINUM SYSTEM AND ACCESSORIES
- K022949 — SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
- K023218 — MODIFICATION TO PLEXOLONG SETS
- K024301 — LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
- K024310 — NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
- K024349 — AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER
- K030194 — XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT
- K030238 — BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
- K030567 — MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM
- K030611 — MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
- K020102 — IQTEQ SPIROMETER
- K021033 — STIMUPLEX-DIG-RC NERVE STIMULATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.