FDA 510(k) clearances — page 951
clearances on record, most recent first.
Clearances — page 951
95,001–95,100 of 175,890- K970089 — INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER
- K970161 — HEDGES CORNEAL WETTING PAK
- K970356 — IRRIGATION/ASPIRATION POLYPECTOMY
- K970538 — VICTORY EYEWEAR CO
- K970994 — CORE AND COIL ASSEMBLY GUIDEWIRE
- K954301 — ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
- K962343 — TOXO IGG ELISA TEST
- K963587 — WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION)
- K964257 — IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
- K964841 — ELECSYS PROGESTERONE ASSAY
- K964844 — CONMED: STAT 2 AND STAT 2 PUMPETTE EXTENSION SETS AND MASTERFLOW AND MASTERFLOW PUMPETTE PRIMARY SETS
- K965186 — AXSYM B12
- K965189 — SPINNAKER
- K970068 — JELENKO NO.1 (CODE NAME RD-0601)
- K970120 — BILE ACIDS REAGENT SET
- K970539 — CHIRON DIAGNOSTICS ACS:180TU P
- K970597 — CULTURE-PAK COLLECTION AND TRANSPORT SYSTEM WITH CLINICAL TRANSPORT MEDIA (CARY-BLAIR OPTION)
- K962010 — EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
- K962376 — KREATIV KURING LIGHT SYSTEM
- K963057 — FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER
- K964003 — METAGEN ALL POLY ACETABULAR CUP SYSTEM
- K964167 — DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY)
- K964522 — ELLIPSE 4
- K964690 — LIBERTY VALVE
- K965120 — ALLCLENZ WOUND CLEANSER
- K965174 — TRUFILL PVA PARTICLES
- K965181 — CES INFUSION CATHETER
- K970134 — THERMAPREP PLUS OVEN
- K970202 — DEPUY ACE AIM TITANIUM TIBIAL NAIL
- K970232 — FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
- K970247 — SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
- K970293 — FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
- K970518 — ALGOPLAQUE HYDROCOLLOID DRESSING
- K970633 — TUSTEX FLAVORED CONDOMS
- K970640 — PHILIPS EASY DIAGNOST
- K970693 — ACRYDERM GEL WOUND DRESSING
- K970721 — DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM
- K962565 — POWERED WHEELCHAIR
- K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
- K963813 — SURE CORE BIOPSY KIT
- K964336 — CMS ACCUPROBE 610, 620, 630, 640, 650, 660, 670, 680
- K964877 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT
- K964954 — SUPERLIGHT
- K965121 — CANNULA
- K965132 — HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES
- K970020 — SIMAR, INC. SURGICAL DRESSING
- K932221 — NEUROLOGICAL OR CRANI TRAYS (PACKS)
- K951728 — SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
- K952558 — AARON VAC 2
- K952910 — THE SWIRLER NEBULIZER
- K953902 — GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM
- K953996 — NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS
- K955461 — TRANSTRACHEAL CATHETER (ACC. RAVUSSIN).
- K960766 — MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
- K960842 — LATEX EXAM GLOVE WITH HYPOALLERGENIC LABELING (POWDERED)
- K961151 — SPINAL NEEDLES
- K961152 — TUOHY EPIDURAL NEEDLES
- K962141 — VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
- K963347 — REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
- K963348 — WALLACH INTEGRATION UNIT
- K963507 — EXTRA TENS (RI-2500) NEO TENS (RI-2000E)
- K963706 — PHILIPS SONO DIAGNOST 800
- K963976 — IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT
- K963994 — NARKOMED GS ANESTHESIA SYSTEM
- K964047 — CRYOSIL SILICONE GEL SHEETING
- K964195 — CHASE TWO STAGE VENOUS RETURN CATHETER
- K964198 — CAHSE AORTIC ROOT CANNULA
- K964199 — CHASE CORONARY SINUS PERFUSION CANNULA
- K964224 — STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE
- K964737 — HYDROPREP GEL
- K965085 — ENZYMUN-TEST PSA
- K965093 — OMNITECH RESECTOSCOPE ROLLER ELECTRODE
- K965125 — DAKOTA SMITH, NICOLE MILLER SUNGLASSES
- K965163 — CUTTERSIL COMFORT
- K965165 — CUTTERSIL COMFORT HARDENER
- K965190 — SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
- K965238 — T1 CONTROL HIGH SPEED DENTAL HANDPIECE
- K970041 — ASCEND BALLOON DAILATION CATHETER
- K970489 — COMEG ENDOSCOPY GRASPING FORCEPS
- K970615 — PROMED 55-G SOFT DAILY WEAR CONTACT LENS
- K962408 — NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT
- K962628 — MOSS MIAMI SPINAL SYSTEM
- K963268 — GENESIS RMP
- K963446 — KENDALL DUAL LUMEN CATHETER
- K964524 — ILT ARGON HP
- K964745 — AMSINO URINARY DRAINAGE BAG
- K964870 — RSV ANTIGEN CONTROL SLIDES
- K964872 — VZV ANTIGEN CONTROL SLIDES
- K964875 — CMV ANTIGEN CONTROL SLIDES
- K964889 — ELECSYS TESTOSTERONE ASSAY
- K964934 — THROMBONOSTIKA F1.2
- K964946 — SYSMEX CA-1000/SYSMEX CA-5000
- K965076 — MDA HEPARIN ANTI-X ASSAY
- K965087 — COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)
- K965142 — VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)
- K965251 — MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
- K970017 — NIDEK CYBERSCAN
- K970151 — INTERCEPTRE LAPAROSCOPIC INSTRUMENTS
- K970279 — RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)
- K970359 — COMBIPROT EMERGENCY ENFUSION DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.