FDA 510(k) clearances — page 1030
clearances on record, most recent first.
Clearances — page 1030
102,901–103,000 of 175,890- K945525 — ANSPACH SUTURE ANCHOR
- K945843 — SAFETY PLUS
- K946054 — DIPLOMAX
- K946150 — CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)
- K946274 — COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
- K946347 — ABSORBABLE ACETABULAR SCREW
- K950575 — BIO-VENT IMPLANT
- K950576 — BIO-VENT X IMPLANT
- K950577 — SWEDE-VENT IMPLANT
- K950578 — SCREW-VENT IMPLANT
- K950579 — MICRO-VENT IMPLANT
- K950875 — OGDEN ANCHOR
- K950933 — HOLLISTER HYDROCOLLOID WOUND DRESSINGS
- K951090 — INTRODUCER
- K951134 — CEDIA VITAMIN B12 (NO BOIL) ASSAY
- K951162 — PHENO-CEN GERMICIDAL DETERGENT
- K951538 — BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT
- K951642 — GOLD CD ULTRA MINI CANAL - MODULE
- K951655 — DURACON RECESSED PATELLA
- K951714 — CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER
- K951721 — APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE
- K951813 — CARIES DETECTOR
- K951861 — STERICARE WOUND CARE GEL
- K951905 — SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSABLE
- K951930 — CEMENTRALIZER DISTAL STEM CENTRALIZER
- K952038 — CLEAN-CUFF
- K952401 — ABELSON CRICOTHYROTOMY CANNULA
- K952643 — RIGHT-ON ADHESIVE BOUDING SYSTEM
- K952689 — BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
- K952723 — DEVMED REUSEABLE TROCAR SYSTEM
- K952814 — ETHICON ARTHROSCOPIC KNOT PUSHER
- K942930 — CAPCARD
- K943226 — BUFFALO FILTER REPLACEMENT FILTER #BSPF030
- K943765 — SHARPS AWAY
- K945934 — URESIL(R) GUIDEWIRE
- K945942 — AUTO SYRINGE(R) AS50 INFUSION PUMP
- K946289 — DEVONS POINT LOK NEEDLE PROTECTION DEVICE
- K950833 — DEPUY SET SCREW
- K951829 — COLD LIGHT SOURCE LOS 150
- K952578 — WELCH ALLY OTOSCOPE
- K952678 — STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT
- K942989 — OCR II & OCM II
- K943227 — BUFFALO FILTER REPLACEMENT FILTER #BSUCF03
- K944052 — RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR
- K944260 — ECG ELECTRODE
- K944451 — PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)
- K944787 — INTEGRATED MOVEMENT ANALYZER
- K945479 — MEDI-TRACE(R) 500 ECG ELECTRODE
- K946322 — POLYGRAM SOFTWARE
- K950485 — GRAPHIC CONTROLS PROTRACE ECG ELECTRODE
- K951812 — MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS
- K951879 — TICARCILLIN/CLAVULANIC ACID 2
- K952351 — PRECISE DENTURE BASE RESIN
- K952428 — POROUS MEDIA DBF23-R REUSABLE RESPIRATORY FILTER
- K931417 — STERILE EQUIPMENT COVERS
- K941612 — F-230 POROUS FEMORAL HIP STEM (CEMENTLESS)
- K943494 — HSG CATHETER SET FOR HYSTERSALPINGOGRAPHY
- K943856 — FIXATION PINS/WIRES
- K945628 — CLEAR ADVANTAGE II
- K946189 — INTROPORT(TM) CATHETER MODEL #1000(ICT)
- K946236 — PROFIX CONFORMING PLUS TIBIAL INSERT
- K946380 — NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA (HEREINAFTER REFERRED TO AS ASPIRATION-V)
- K950711 — T-350 THERAPEUTIC COOLING MACHINE
- K951118 — 3M MAXI-DRIVER II ELECTRIC SYSTEM
- K951524 — THORACENTESIS CATHETER
- K951673 — ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
- K951716 — AMS 650 MALLERABLE PENIEL PROSTHESIS
- K951759 — GSI 65 COMPUTERIZED AUDIOMETER
- K951805 — PIPER, MODEL NUMBER UDS-PIPERB
- K951806 — OPGAL INTRAOPERATIVE VASCULAR ANGIOGRAPHY SYSTEM (IVA-2000)
- K951808 — MED-TEC REDI-FOAM
- K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR
- K952357 — THE HILL ADJUSTABLE PODIATRY MODEL
- K952408 — ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
- K952450 — WIDE DYNAMIC RANGE COMPRESSION WITH ACTIVE TONE CONTROL
- K952451 — CLASS D LINEAR WITH ACTIVE TONE CONTROL
- K952452 — OUTPUT COMPRESSION LIMITER WITH ACTIVE TONE CONTROL
- K952477 — STAT PROFILE ULTRA BLOOD GAS CONTROLS
- K952537 — THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D.
- K952641 — QUICKIE TSR
- K952701 — MED-TRON SPECT IMAGING TABLE
- K932350 — ORTHOPEDIC SCREW FIXATION
- K932352 — ORTHOPEDIC BONE PLATE
- K943986 — LINK ENDO MODEL REVISION CUP
- K951533 — EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
- K951736 — LOCK-UP
- K951993 — UBI MAGIWEL FERRITIN QUANTITATIVE
- K952161 — BIPOLAR COAGULATION INSTRUMENT
- K952182 — OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES
- K952261 — HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%
- K952367 — CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE
- K952425 — OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT
- K952432 — SYMBIOSIS BIPOLAR FORCEPS
- K932922 — PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR
- K935788 — BICORE SMARTCATH INTRATRACHEAL CATHETER
- K943806 — HARPOON SUTURE ANCHORS
- K945985 — PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400
- K950488 — GRAPHIC CONTROLS BIOTAC ECO ELECTRODE
- K950489 — GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE
- K950816 — ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.