FDA 510(k) clearances — page 1244
clearances on record, most recent first.
Clearances — page 1244
124,301–124,400 of 175,890- K904035 — REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
- K904092 — LANCER ORIGINAL, SIERRA, GENERAL PURPOSE
- K904097 — PHOTAC-BOND APLICAP
- K904128 — PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
- K904228 — OSSEODENT DENTAL ATTACHMENTS (NON-ANGLED)
- K904301 — DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD
- K904753 — DIOLASE
- K904768 — KODATROL I AND II CONTROL AND DILUENT SET
- K901598 — FASTIDIOUS MIC PANEL
- K901659 — TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
- K902214 — BIOPSY NEEDLE TRANSPONDER SYSTEM
- K902614 — ELVI 828 DIGICLOT MULTISCAN
- K903221 — LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN
- K904121 — VIALON OBTURATOR
- K904341 — APTT REAGENT
- K904936 — PATIENT EXAMINATION GLOVES
- K902099 — WILSON-COOK VARICES TAMPONADE BALLOON CUFF
- K902981 — G.E. FLUOROCON 300 IMAGING SYSTEM
- K903139 — BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743)
- K903159 — VALVE CONTROLLER FOR MICROMACRO COMPOUNDER
- K903613 — HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)
- K903623 — MODEL600 UTERINE ACTIVITY MONITOR
- K903625 — DOPPLER NEEDLE AND FLOW MONITOR
- K903701 — XPRESS
- K903813 — URETERAL BALLOON DILATATION CATHETER
- K903821 — PSC-1 W/OTHER NUMERICAL
- K904067 — LASERSAT CO2
- K904093 — BUCCAL TUBE, BUCCAL ATTACHMENT
- K904320 — STERILE SURGEONS GLOVES (ULTRA-TOUCH-LATEX)
- K904714 — CIBA CORNING ACS PROLACTIN IMMUNOASSAY
- K904818 — XCALIBER
- K904913 — HANDI-TRAK WHEELCHAIR SNOW CHAINS
- K902983 — SIEMEN'S SIREMOBILE II C-ARM
- K903441 — MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
- K903560 — CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS
- K903582 — ECHOMARK PTA ULTRASONICALLY LOCATED BALLOON CATH.
- K904033 — REFLOTRON POTASSIUM TEST TABS
- K904307 — DUPONT SALICYLATE CALIBRATOR
- K904387 — BIOCLONES ELEGANCE LH ELISA KIT
- K904623 — RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235
- K904815 — QMS TM- PHENYTOIN
- K896729 — NELATON-, FEMALE - OR TIEMANN CATHETER
- K900720 — MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)
- K901015 — WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC
- K901064 — MONOHAEM (FECAL OCCULT BLOOD TEST)
- K901587 — TSRH SACRAL L-CONNECTOR
- K902119 — SAFEBRIS STERILE CIRCUMCISION KIT
- K902397 — MODULOCK POSTERIOR SPINAL FIXATION
- K902654 — CDI (TM) SYSTEM 100 MONITORING SYSTEM
- K902771 — ARTERIAL BLOOD SAMPLING KIT
- K903056 — BACTTRAP
- K903149 — CHANLLENGE 1010 PATIENT KEY PROGRAM STATION
- K903487 — SOLARSHIELDS ENCORE
- K903555 — ELECTROTRACE DISPOSABLE AG/AGCL EKG MON. ELEC.
- K903646 — GASTROGRAPH
- K903878 — MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
- K904091 — TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO
- K904197 — CHILDRENS SUNGLASSES
- K904225 — KWIKMIX
- K904334 — PERCUTANEOUS INTRAVENOUS CATHETER REPAIR KIT
- K904413 — CEDIA(TM) PHENOBARBITAL ASSAY
- K904483 — ELEGANCE PROLACTIN ELISA
- K904803 — CAP-EVAC ADAPTER
- K904817 — MAGNUM
- K904862 — HANDI-TRACTION
- K895435 — FRESENIUS AS 104 CELL SEPARATOR
- K896732 — UNOMETER 500
- K900371 — MENTOR MODIFIED MALLEABLE PENILE PROSTHESES
- K902700 — HEVEASHIELD EXAMINATION GLOVES
- K902956 — LATEX EXAMINATION GLOVES
- K903238 — AFGA VIDEO IMAGER, VARIOUS MODELS
- K903382 — ALLERGY CONTROL COVERS
- K903532 — UNNA-SLEEVE(TM)
- K903649 — BRADLEY TENACULUM HOLDER
- K903763 — COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K904089 — PERMA MESH
- K904094 — C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE
- K904160 — CYTOSMEAR BRUSH
- K904278 — HOLDER, DENTAL BUR, ALUMINUM
- K904479 — SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015
- K904503 — SERACON CR REFERENCE
- K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008
- K904675 — QBC SYSTEM MCHC
- K904733 — QUALICHECK 3
- K902741 — VASCUMED EZ Y-CONNECTOR
- K902837 — AMICON DIAFILTER 30 HEMOCONCENTRATOR
- K902958 — TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
- K904141 — TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III
- K904163 — CLINICAL BLOOD GAS MIXTURES
- K904204 — THROMBELASTOGRAPH
- K904289 — PERTAC UNIVERSAL BOND
- K904437 — ARGENCO 19
- K904497 — CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST
- K904635 — MICROZYME THC ENZYME IMMUNOASSAY TEST KIT
- K904673 — OTICAON BTE MODEL E34P
- K900094 — PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
- K900217 — BARD MICROBORE ANTI-SIPHON NITRO SET
- K901705 — CUSTOMED CYSTO PACK II
- K901923 — INVOTEC POLY-MESH MANDIBULAR TRAY
- K902191 — CUSTOMED LAP PACK II
Data sourced from openFDA. This site is unofficial and independent of the FDA.