FDA 510(k) clearances — page 1001
clearances on record, most recent first.
Clearances — page 1001
100,001–100,100 of 175,890- K960310 — EPIC INTRODUCER SHEATH
- K950087 — LOT 440
- K950306 — IMTEC BIOBARRIER
- K952186 — HSW GMBH HYSTEROSCOPES & ACCESSORIES
- K952517 — QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
- K952687 — PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM
- K952847 — NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
- K953363 — OXIFLOW DIGITAL RECORDER
- K954282 — ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG
- K954388 — CONMED 2710 CLEARTRACE 2 LT MONITORING ECG ELECTRODE
- K954593 — THE AIRCEL SYSTEM
- K954783 — DRYSLIDE CARTARRHALIS
- K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
- K955293 — FIBERED PLATINUM COIL, .035 TYPE
- K955598 — CLARUS SPINEPEN MODEL 2126
- K955647 — VIDAS ESTRADIOL II (E2II) ASSAY
- K955870 — IMMULITE TOTAL TESTOSTERONE
- K955896 — MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11
- K960104 — BIOCCLUS 4
- K943367 — IL TEST CHOLINESTERASE
- K953274 — GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM
- K953585 — SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER
- K953853 — IAMIN GEL WOUND DRESSING
- K953968 — AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
- K954632 — SIEMENS SC 9000 ETCO2 MODULE
- K954727 — SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION)
- K954872 — CANDELA CRYO-PROBE HOLDER
- K954898 — PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
- K955099 — SORBIE TOTAL ELBOW SYSTEM
- K955103 — 3M NO STING BARRIER FILM
- K955153 — LYPHOCHEK BENZO/TCA CONTROL-SET B
- K955165 — SYNTHETIC SPONGE
- K955500 — FMS ARTHOPROBE
- K955504 — QBC ACCUREAD SYSTEM
- K955527 — GENERAL USE SYNTHETIC SPONGE (STERILE)
- K955769 — ACCESS PROGESTERONE ASSAY
- K943224 — VARIAN MULTILEAF COLLIMATOR
- K945264 — OPTUS OTOSCOPES
- K951246 — PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS
- K952390 — BRAINLAB STEROTATIC HEADRING
- K953564 — MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE
- K953579 — TEE PROBE
- K954161 — JPI INTENSIFYING SCREEN
- K954294 — HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES
- K954934 — CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
- K955186 — SAS SALMONELLA H Z29 ANTISERUM
- K955187 — SAS SALMONELLA H Z4, Z23 ANTISERUM
- K955188 — SAS SALMONELLA H Z6 ANTISERUM
- K955189 — SAS SALMONELLA H Z ANTISERUM
- K955190 — SAS SALMONELLA H Y ANTISERUM
- K955191 — SAS SALMONELLA H X ANTISERUM
- K955192 — SAS SALMONELLA H T ANTISERUM
- K955193 — SAS SALMONELLA H S ANTISERUM
- K955194 — SAS SALMONELLA H R ANTISERUM
- K955198 — SAS SALMONELLA H POLY C ANTISERUM
- K955199 — SAS SALMONELLA H POLY B ANTISERUM
- K955200 — SAS SALMONELLA H POLY A ANTISERUM
- K955201 — SAS SALMONELLA H,M,T, ANTISERUM
- K955202 — SAS SALMONELLA H L,Z40 ANTISERUM
- K955203 — SAS SALMONELLA H L,Z13 ANTISERUM
- K955204 — SAS SALMONELLA H L,W ANTISERUM
- K955205 — SAS SALMONELLA H L,V ANTISERUM
- K955206 — SAS SALMONELLA H K ANTISERUM
- K955207 — SAS SALMONELLA H I ANTISERUM
- K955208 — SAS SALMONELLA H H ANTISERUM
- K955209 — SAS SALMONELLA H G,M ANTISERUM
- K955210 — SAS SALMONELLA H F,G, ANTISERUM
- K955252 — NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4
- K955257 — SS102 DUAL CHANNEL SEP STIMULATOR
- K955260 — NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION
- K955264 — NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2
- K955288 — HEARING AID IMPRESSION MATERIAL
- K955692 — FINETONE FSC,
- K955801 — RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
- K955867 — RESOUND PERSONAL HEARING SYSTEM BT247
- K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT
- K953694 — DEPUY VISION AML HIP PROTHESIS
- K953703 — DEPUY VISION SOLUTION HIP PROSTHESIS
- K954169 — HANAULUX BLUE 30 & 80
- K954714 — AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
- K954848 — HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
- K955364 — SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K955404 — OTV-S5 OES VIDEO SYSTEM
- K955683 — RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY
- K955836 — VALLEYLAB COATED ELECTRODES
- K945215 — MARS DIGITAL BLOOD PRESSURE MONITOR
- K945938 — RESPIRONICS MONARCH MINI MASK
- K952491 — MODEL 7355
- K952859 — ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT
- K953200 — ULTIMA SIZE 0 CEMENTED FEMORAL STEM
- K953202 — P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT
- K953560 — MITEK THREADED ANCHOR (FASTIN)
- K953609 — PRODEK
- K953925 — FINE GRAIN CAST COBALT CHROMIUM HIP STEMS
- K954013 — TRILASE 2940 ERBIUM LASER
- K954207 — GEL MASK
- K954443 — LACTOSORB SUTURE ANCHOR
- K954787 — ILLUMINATOR
- K954835 — HOLGRATH COMBINED SPINAL EPIDURAL NEEDLE SET
- K954909 — PROFIX POSTERIOR-STABILIZED KNEE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.