FDA 510(k) clearances — page 956
clearances on record, most recent first.
Clearances — page 956
95,501–95,600 of 175,890- K964769 — VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
- K964953 — IN-TAC BONE ANCHOR SYSTEM
- K962717 — 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
- K963004 — BIONECT CREAM
- K963100 — TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP
- K963101 — B-P HEMISPHERICAL ACETABULAR COMPONENT
- K963115 — TROCAR CANNULA
- K963326 — BREATHE FIT
- K963683 — TRU-PULSE LASER (MODIFIED)
- K963700 — METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM
- K963808 — CHOICE POWERED WHEELCHAIR
- K964783 — EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT
- K964846 — IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
- K965069 — ANSPACH SUTURE ANCHOR
- K965162 — LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.
- K970365 — PASSY-MUIR O2 ADAPTER; PMA2000
- K935706 — EPI 2
- K945290 — 8500A PULSE OXIMETER
- K955183 — SAFE KNIGHTS
- K955543 — ULTRASOUND SYSTEM MODEL UF-3500
- K960817 — HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2)
- K963727 — HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
- K963945 — STERI-OSS GOLD ATTACHMENT SYSTEM
- K964009 — IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS
- K964369 — TRACH CARE SET WITH MICROBAN
- K964461 — ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST
- K964462 — ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
- K964536 — ONE-STEP DIPSTICK PREGNANCY TEST
- K964544 — OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
- K964561 — ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA
- K964657 — SUPER K-AMP, EZ-COMPRESSION, TRIM-PRO, HF-PRO, ENVIRO-PRO, COMPRESSION-PRO, COMPRESSION 3000, HF 3000, OCTIVA, REFLEX HF
- K964678 — PHASED ARRAY NECK COIL
- K964697 — AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION
- K964740 — THE NOMOS MINICRANE
- K964753 — MATRIX 3000 FLEXIBLE SPINE COIL
- K964803 — UNIVISION ECHOCARDIOLOGY SYSTEM
- K964840 — BEAM BLOCK TRAYS
- K964854 — MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
- K964858 — BEMIS TWO GALLON CHEMOTHERAPY CONTAINER
- K970248 — CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
- K941397 — ANTI-VIMENTIN PRIMARY ANTIBODY
- K941516 — VENTANNA ANTI-DESMIN PRIMARY ANTIBODY
- K946279 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
- K961321 — GAMMA GUIDANCE SYSTEM
- K961552 — CVP POLYURETHANE CATHETER
- K961974 — FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE
- K962084 — OMNICAN SYRINGE
- K962576 — SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K962828 — EVERT-IT
- K962835 — HEARTPORT ENDOVENOUS DRAINAGE CANNULA
- K963730 — PROTEC (1024)
- K963804 — PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
- K963830 — SHARPS CONTAINER MODEL# SC001
- K963831 — SHEATHES (NON-LATEX)
- K963866 — AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)
- K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
- K964004 — GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
- K964010 — IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
- K964174 — MINERAL TRIOXIDE AGGREGATE (MTA)
- K964260 — IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG
- K964372 — CARDIAC T TROPONIN T RAPID ASSAY
- K964520 — PARASCAN SCANNING DEVICE
- K964523 — RECOVER INFANT HEEL WARMER (5100)
- K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER
- K964626 — EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE
- K964628 — NITRILE POWDER-FREE EXAMINATION GLOVES
- K964629 — VINYL PATIENT EXAMINATION GLOVES
- K964630 — GLUCOMETER ELITE BLOOD GLUCOSE METER
- K964647 — NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
- K964656 — TEFGEN GUIDED TISSUE MEMBRANE
- K964747 — SOMATOM PLUS 4 CT SCANNER
- K964810 — DERMADAM
- K964812 — NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET
- K964859 — SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
- K964862 — TROPONIN-I TEST SYSTEM
- K964931 — WHITE CORE
- K964944 — ROUND DENTAL BUR
- K964981 — TEMPFIL C&B
- K965026 — PFINGST PRESSURE PASTE
- K965202 — VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
- K965213 — STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
- K970054 — TANDEMRX
- K970147 — ELECSYS CALCHECK PROLACTIN
- K970148 — ELECSYS CALCHECK ESTRADIOL
- K970254 — SEIRIN PYONEX ACUPUNCTURE NEEDLES
- K970260 — SEIRIN JR ACUPUNCTURE NEEDLES
- K962246 — RIGID FIBER OPTIC LAPAROSCOPE
- K962718 — FEMEXAM TESTCARD
- K962737 — AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN)
- K963023 — ULTRASOUND GASTROSCOPE GF TYPE UM30P
- K964148 — PATIENT EXAMINATION GLOVES; CHLORINATED POWDERFREE NITRILE EXAMINATION GLOVES
- K964315 — REMEL STAPH LATEX KIT
- K964487 — IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964489 — CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964490 — AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964491 — NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964492 — CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964495 — CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K964672 — SUTURE APPLICATOR
- K964701 — MITRAFLEX PIGMENTED WOUND DRESSING
Data sourced from openFDA. This site is unofficial and independent of the FDA.