FDA 510(k) clearances — page 525
clearances on record, most recent first.
Clearances — page 525
52,401–52,500 of 176,542- K092499 — LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET)
- K092522 — ACU007S
- K092591 — ORTHOPANTOMOGRAPH OP30
- K092607 — AJUST ADJUSTABLE SINGLE INCISION SLING
- K092702 — MICRUS MICROCATHETER, MODEL COURIER 270
- K092730 — COSMEDENT BRUSHABLE COMPOSITE
- K092868 — CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
- K092993 — ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
- K093303 — SCOUTPRO 7F LONG CATHETERS
- K093451 — OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP
- K093462 — SONIX ULTRASOUND SCANNER
- K093488 — ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
- K093512 — ENCOR BREAST BIOPSY SYSTEM
- K083273 — MICRODOT XTRA
- K090682 — EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00
- K091263 — ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)
- K091657 — IMMUNOSCAN CCPLUS
- K092395 — OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
- K092420 — KRD1 PEDICLE SCREW SYSTEM
- K092429 — ENDOGATOR
- K092503 — RADAR VASCULAR COMPRESSION DEVICES
- K092670 — BIODRIVE MICRO SCREW SYSTEM
- K092797 — ACUTE AND CHRONIC CATHETER REPAIR KIT
- K093399 — PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520
- K083757 — BPZ02 MULTIPURPOSE SOLUTION
- K090888 — NEWPORT HT70 FAMILY OF VENTILATORS
- K090915 — STERILE WATER FOR INHALATION FLEX BAG, USP
- K091714 — ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579
- K091874 — INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656
- K091924 — VPS CATHETER
- K092040 — PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240
- K080459 — CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS
- K091031 — PIONEER SURGICAL NANOSS BVF-E
- K091157 — GLUCO LAB AUTO CODING, MODEL IGM-0022
- K091813 — INTREPID SPINAL SYSTEM
- K091973 — METASUL TAPER LINERS, METASUL FEMORAL HEADS
- K092239 — ROSA SURGICAL DEVICE, MODEL ROSA 1.1
- K092271 — GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
- K092374 — OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN
- K092401 — SINEXUS SINUS STENT GEN 2, MODEL 1999-25
- K092556 — SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS
- K092568 — SPARTAN S3 FACET SYSTEM
- K092609 — SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP)
- K092659 — SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25
- K092737 — EASYRA MG REAGENT, MODEL 10220
- K092877 — INDISCAL ASPIRATION DEVICE AND ACCESSORIES
- K093256 — SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018
- K093291 — VARIAN INTERSTITIAL TITANIUM NEEDLES
- K093337 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
- K093389 — CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK
- K093423 — LUNGPOINT PROCEDURE PLANNING
- K091382 — KRYPTONITE BONE CEMENT
- K091664 — GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C
- K091815 — SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
- K092146 — XTEND ANTERIOR CERVICAL PLATE SYSTEM
- K092163 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
- K092168 — ELECSYS HCG+B CALCHECK 5
- K092549 — OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P
- K090532 — T.E.A.R. TECH3
- K090730 — AKITA JET
- K091061 — IMPLICITGUIDE SURGICAL SUTURE SYSTEM
- K091176 — PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441
- K091686 — LEFORTE NEUROSYSTEM BONE SCREW
- K091724 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
- K091730 — BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
- K091754 — LUNETTE MENSTRUAL CUP, MODELS 1 AND 2
- K091865 — SPORT-ELEC BODY CONTROL SYSTEM
- K092113 — STA - FREE PS CALIBRATOR
- K092619 — ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER
- K093032 — TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
- K093089 — MAGNUM NAIL
- K093286 — POWERCROSS .018 OTW PTA DILATION CATHETER
- K091752 — VIZTEK WL
- K092246 — NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505
- K092501 — LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL
- K092597 — CENTROS CHRONIC HEMODIALYSIS CATHETER SET
- K092826 — ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
- K093169 — SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)
- K093253 — AMID STAPLER
- K093402 — AUTOSUTURE EEA ORVIL
- K093408 — V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
- K093410 — AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY
- K090739 — BARD SACROCOLPOPEXY GRAFT
- K091272 — BESMED JET NEBULIZER BOTTLE SET
- K092434 — STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM
- K092487 — HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
- K092741 — COLOR LCD MONITOR, MODEL RADIFORCE MX241W
- K092858 — SAFERSONIC SONOGRAPHY COVER
- K092888 — ELECSYS TOXO IGG CALCHECK 5
- K092899 — OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4
- K092997 — ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
- K093068 — FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US
- K093236 — ETHICON ENDO-SURGERYOPTICAL DILATOR
- K091725 — PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549)
- K092464 — SPINEOLOGY FACET SCREW
- K092735 — GREENLIGHT XPS LASER SYSTEM
- K093224 — DENSICHECK PLUS
- K090578 — SHIMADZU COLLIMATOR R-30H
- K090605 — CLAMPFIX
- K091241 — MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.