FDA 510(k) clearances — page 1280
clearances on record, most recent first.
Clearances — page 1280
127,901–128,000 of 175,890- K896380 — IC-2A MRI ADULT/PEDIATRIC VENTILATOR
- K896381 — MVP-10 MRI INFANT VENTILATOR
- K896532 — DENTAL DELIVERY SYSTEM
- K896597 — THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.
- K896612 — DOBBHOFF(R) PAPILLOTOME
- K896629 — NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR
- K896691 — BITE BLOCK
- K896696 — (HEART) NEBULIZER
- K896844 — BABE-EASE NEONATAL CLOTH ECG ELECTRODE
- K900227 — MVP (MULTI-VENDOR PROTOCOL CONVERTOR)
- K884962 — ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA
- K885309 — WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS
- K891784 — BI-O.K.(TM)-BIOLOGICAL/CHEMICAL INDICATOR
- K894549 — DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE
- K895095 — AKS II
- K895189 — ADJUSTABLE SOFT PALATE LIFTER
- K895293 — KEMI LABS - ADHESIVE BANDAGE REMOVER
- K895420 — SUCTION BIOPSY INSTRUMENT
- K895506 — FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER
- K895548 — CONVEEN INTERMITTENT CATHETERS
- K895882 — JMS DIALYZER PRIMING SET
- K895885 — AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING
- K896018 — BIOTEMP
- K896470 — EOS IMPRESSION TRAYS
- K896473 — H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR
- K896501 — TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
- K896517 — ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER
- K896539 — PERMADYNE GARANT LOW VISCOSITY
- K896564 — DENTAL CORE MATERIAL
- K896566 — MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
- K896821 — OLYMPUS URETERO. & CIRCON ACMI URETERO. GUIDE
- K896891 — LEUKOSILK(TM) SURGICAL TAPE
- K900043 — MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER
- K900055 — MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS
- K900098 — MONOPOLAR NEEDLE ELECTRODE
- K900144 — QUARTZ FIBER CATHETERS AND SURGICAL TIPS
- K900279 — OCULINUM INJECTION AMPLIFIER
- K900401 — NAS&P GRASPING FORCEPS & ASSOC. DEVICES
- K900455 — ZEFAZONE SUSCEPTIBILITY POWDER
- K900487 — MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE
- K892380 — DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III
- K894543 — MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
- K895136 — PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
- K895639 — MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR
- K896463 — RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1
- K896466 — SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
- K896477 — NICOLET REAL EAR ANALYZER
- K896478 — LUXAR MODEL LX-20 MINILASE CO2 LASER
- K896650 — AMYLASE REAGENT
- K896686 — AMRESCO CREATININE REAGENT #4316100
- K896697 — PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI
- K896804 — MANIFOLD
- K896900 — ENZYMUN TEST R T3
- K896901 — ENZYMUN TEST R HCG
- K896992 — METAL URETERAL BASKET STONE DISLODGER
- K900215 — COULTER PHOSPHORUS REAGENT
- K900216 — COULTER ALP (ALK PHOS) REAGENT
- K896435 — HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
- K890328 — ADULT RESECTOSCOPE
- K894953 — GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS
- K896546 — HOMEPUMP (DISP. ELASTOMERIC INFUSION DEVICE)
- K896556 — UNIVERSAL POOLE SUCTION TUBE
- K896557 — YANKAUER SUCTION TUBE-FLEXIBLE TYPE
- K896558 — YANKAUER SUCTION TUBE-RIGID TYPE
- K896562 — STOPCOCK
- K896563 — TUBING CONNECTORS
- K896611 — OLYMPIC LIGHT-WARM
- K896669 — WEBER PERMALOCK
- K896856 — MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS
- K896886 — ARTEC RESPOND PULMONARY RESUSCITATOR
- K897064 — LAPAROSCOPIC ACCESS SHEATH SET
- K900007 — R-100-ET MANUAL COLLIMATOR
- K893861 — TMI LW-100 PULSED DOPPLER SYSTEM
- K894956 — CIRCAMED HOLTER VERSION 4
- K896332 — SUPPLEMENT TO ANAEROBIC MIC PANEL
- K896430 — PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI
- K896971 — CARDIAC COOLING JACKET, 8 CM, MODEL CJ-420
- K896972 — CARDIAC COOLING JACKET, 12 CM, MODEL CJ-520
- K896973 — CARDIAC COOLING JACKET, 30% ENLARGED, MODEL CJ-320
- K896974 — CARDIAC COOLING JACKET, 8 CM, MODEL CJ-120
- K896975 — CARDIAC COOLING JACKET, 30% REDUCED, MODEL CJ-220
- K897067 — MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
- K897136 — PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357
- K900062 — U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL
- K900103 — CRONEX QUANTA SR300 INTENSIFYING SCREEN
- K900126 — TT AND HNTT BY HEMOCHRON
- K900318 — CRONEX QUANTA SUPER RAPID SR339 RARE EARTH
- K900344 — CEFIXIME 5 MCG SUSCEPTIBILITY DISK
- K900449 — PHARMACIA B2 MICRO EIA
- K883911 — ELECTRO-ACUSCOPE 85
- K891289 — FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP
- K892390 — FLEXIBLE IMMERSIBLE HYSTEROSCOPE
- K892642 — DADE(R) TDM CONTROL
- K894403 — PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT
- K894844 — BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
- K895629 — MODEL 8100; UPPER EXTREMITY COIL
- K895953 — WRIGHT VENTILOMETER VM-1
- K896183 — KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY
- K896361 — HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE
- K896379 — ACS GOLD SERIES ELASTINITE GUIDE WIRE
Data sourced from openFDA. This site is unofficial and independent of the FDA.