FDA 510(k) clearances — page 650
clearances on record, most recent first.
Clearances — page 650
64,901–65,000 of 176,637- K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
- K052903 — PEDIATRIC FEEDING TUBE
- K052916 — USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
- K052978 — GE 1.5T SIGNA HDE MR SYSTEM
- K053040 — PARACEM UNIVERSAL DC
- K042691 — VERTEFIX VERTEBROPLASTY PROCEDURE SET
- K051082 — MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED)
- K051647 — FORTADERM ANTIMICROBIAL WOUND DRESSING
- K052545 — INFINITT G3 PACS
- K052595 — CRC 15ULTRA
- K052698 — MODIFICATION TO: AURORA
- K052709 — POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE
- K052877 — POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
- K052897 — GE DEFINIUM AMX 700, MODEL AMX 700
- K052987 — BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC
- K052995 — ADVANTAGE WORKSTATION 4.3.
- K053018 — POLY SILOXANE IMPRESSION MATERIAL
- K053046 — ILUMA ORTHOCAT/DENTALCAT
- K043007 — BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
- K052280 — FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
- K052406 — UNI-THREAD SPINAL SYSTEM
- K052437 — MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
- K052576 — SBI AUTOFIX
- K052607 — ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
- K052638 — ABBOTT SPINE, INC. SPINNAKER SYSTEM
- K052656 — VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN
- K052910 — POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS
- K052913 — IGNITE BONE VOID FILLER KIT
- K053030 — J. MORITA AZ ULTRASONIC SYSTEM
- K043207 — OZONE GENERATOR
- K050407 — LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60
- K050883 — SAFERSLEEP SYSTEM
- K051061 — KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
- K051205 — STRYKER SPINE AVS ASL PEEK SPACER
- K051274 — INVOS SYSTEM
- K051312 — SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
- K051583 — TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
- K052018 — MILTEX LIGATING CLIP
- K052019 — NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE
- K052182 — SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S.
- K052456 — MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM
- K052483 — SYNTHES (USA) SPHERICAL WASHERS
- K052496 — PRIMECHAIR
- K052504 — GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
- K052505 — CALF IMPLANT, MODEL EC17-X
- K052650 — PIONEER U601 SERIES ASPIRATOR
- K052663 — INO THERAPEUTICS INOBLENDER, MODEL 10004
- K052791 — MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
- K052932 — CRYPTOSPORIDIUM II
- K053024 — SYNGO NEURO DSA CT
- K050271 — KOWA GENESIS-D HAND-HELD RETINAL CAMERA
- K050296 — ECLIPSE TREATMENT PLANNING SYSTEM
- K051914 — GENEROS 80, GENEROS 60
- K051998 — REGIUS MODEL 170 DIRECT DIGITIZER
- K052095 — MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190
- K052137 — ASCENSION MUH
- K052435 — PNEUMRX FAMILY OF BIOPSY NEEDLES AND KITS
- K052494 — NOVABONE-BIOACTIVE SYNTHETIC GRAFT
- K052533 — KIMBA SPINAL IMPLANT
- K052541 — MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM
- K052704 — MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE
- K052736 — ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
- K050571 — ABSOLUTE AMERICA
- K051206 — Y2K2 ENTERNAL TUBE FLUID FILTER
- K051561 — ASAHI ANGIOGRAPHIC CATHETER
- K051799 — DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
- K052195 — EZ-MIO MANUAL DRIVER
- K052213 — NAVIGATION SW HIP 3.1 ON CI
- K052253 — MODIFICATION TO: DRYAC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
- K052268 — VISUCAM PRO NM
- K052507 — TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR
- K052722 — LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS
- K052801 — INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
- K052809 — SAUFLON FLAT COLOURED LENS CASE
- K052880 — DATEX-OHMEDA S/5 INTERFACE MODULE E-INT
- K051804 — ABL80 FLEX ANALYZER
- K052370 — CP BRACKET SYSTEM
- K052470 — F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
- K052756 — DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM
- K052802 — MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
- K052815 — QMS AMIKACIN REAGENTS
- K052827 — MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
- K052883 — CARDIOSERVER
- K052909 — EVENFLO ELAN BREAST PUMP
- K052981 — BIS EEG MONITOR, MODEL BISX4
- K051580 — VP SHEATH
- K051589 — SLIMMANAGER, MODEL SM-X, SM-E
- K051637 — DSNARE, MODEL 00711087
- K052105 — WATER FILLED TEETHER
- K052106 — SIMILE FLOW
- K052379 — MIM 3.5 (CIRCA)
- K052770 — PATHFORMER
- K052775 — SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)
- K052890 — NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
- K052911 — ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM
- K052979 — 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE
- DEN050006 — CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
- K050233 — OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI
- K051276 — HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
- K051476 — UNI-VENT MODEL 73X
Data sourced from openFDA. This site is unofficial and independent of the FDA.