FDA 510(k) clearances — page 950
clearances on record, most recent first.
Clearances — page 950
94,901–95,000 of 175,890- K970831 — REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
- K970833 — INDOLE SWAB
- K970976 — CARDIOIMMUNE CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
- K970979 — LIQUID CSF(LCR)1, LIQUID CSF(LCR)2
- K970984 — THE ELECSYS CALCHECK PROGESTERONE
- K952683 — APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE
- K954547 — CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER
- K954730 — BENCHMARK TRANSFER TEST
- K961156 — ONCE-A-DAY BOWIE AND DICK TEST PACK.
- K963428 — UMBILICAL CLAMP AND CUTTER
- K964074 — DIOLITE 532
- K964107 — OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR
- K964517 — LINAC SCALPEL FLOORSTAND
- K970010 — FPT NEBULIZER
- K970035 — JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009
- K970290 — EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
- K970434 — NEO-PICC
- K970450 — UPSCAN 120
- K970603 — D SERIES ELECTRODE
- K970924 — REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE
- K970975 — PROSTYLE INTRA
- K962370 — PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE
- K963843 — ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT
- K963887 — PT-PAC PORTABLE HEATING PAD
- K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER
- K963983 — E. CAM PROFILE ATTENUATION CORRECTION
- K964555 — VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)
- K964739 — STERI-OSS TIODIZED SCREW
- K964853 — INTRAVIA CONTAINER, EMPTY
- K965185 — ACRYPAK FOLDER
- K970215 — AUDALLION II HEARING SYSTEM
- K970262 — MULTI-CHANNEL COMPRESSION BTE (SD)
- K970268 — ALEXANDER MANUFACTURING COMPANY PRCHARGEABLE BATTERY
- K970349 — FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667
- K970377 — PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
- K970479 — MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
- K970521 — TRX POWER TILT AND RECLINE SYSTEM
- K970594 — KALGINATE IMPRESSION MATERIAL
- K970722 — EYE TRAY
- K970744 — STYLE EYES OPTICS
- K951944 — NASALFLAIR
- K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA)
- K960840 — C.E. VASCULAR MACHINE
- K961676 — AIRCAST VENAFLOW SYSTEM (MODIFICATION)
- K961782 — BIO-BINKI
- K962687 — GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
- K963051 — ERCP CANNULA
- K963262 — ARTOSCAN M
- K963293 — AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
- K963688 — FOCUS PV BALLOON DILATATION CATHETER
- K964346 — PARAMAX TRIGLYCERID REAGENT
- K964441 — FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSU
- K964971 — CRYOGEN CRYOSURGICAL SYSTEM
- K965214 — COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
- K965239 — PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)
- K970005 — GYREX 2T-PRESTIGE
- K970018 — FAST TRACT TRANSTRACHEAL PROCEDURE KIT
- K970046 — UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)
- K970053 — ULTRATOMERX
- K970130 — HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING
- K970140 — E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH
- K970170 — SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE
- K970244 — SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
- K970537 — REXTON MODEL 48 AND 49PP
- K970541 — AESCULAP MODULAR MONOPOLAR ELECTRODES
- K970565 — MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
- K970737 — B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
- K970762 — DUAL LUMEN EMBOLECTOMY CATHETER
- K970826 — SELECTA-TIP LAPAROSCOPIC SCISSORS
- K971057 — COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
- K964021 — INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)
- K964387 — POINT OF USE II SHARPS-A-GATOR
- K965091 — TEETHMATE F-1
- K970076 — NIPRO DISPOSABLE SOLUTION INFUSION SET
- K970111 — JIAWANG POWDER-FREE VINYL EXAMINATION GLOVES
- K970433 — AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL
- K970440 — EKONIC DENTAL/MEDICAL MASK (MD 610)
- K970625 — POLY-MED
- K970788 — PNEUMO-MATIC INSUFFLATION NEEDLE
- K970815 — CONVERTORS IMPERVIOUS SHOE COVERS
- K960849 — MAGNO ALARM
- K961459 — LEVEL 10 HDI
- K963775 — MODEL 8800 ASPIRATOR
- K964024 — DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM
- K964404 — BACFIX SPINAL FIXATION SYSTEM
- K964891 — ORBSHOT KERATOMETER
- K964915 — MAGNESIUM
- K965129 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
- K965131 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
- K970340 — AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
- K970402 — DOCTORS REVIEW SYSTEM
- K970904 — WIDEX SENSO DIGITAL (CIC)
- K962970 — SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION
- K963203 — BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
- K963325 — SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
- K964359 — AVANTA ORTHOPAEDICS TENDON SPACER
- K965019 — THE C-FIT FEMORAL HIP SYSTEM
- K970019 — MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
- K970036 — FIXATION PIN OR ROD
- K970052 — EXTRACTORRX
Data sourced from openFDA. This site is unofficial and independent of the FDA.