FDA 510(k) clearances — page 981
clearances on record, most recent first.
Clearances — page 981
98,001–98,100 of 175,890- K961736 — 17 ANGULATED ABUTMENT
- K961856 — AUTO SUTURE CHEMOSITE TUNNELER
- K961933 — CIRCLE NEPHROSTOMY CATHETER SET
- K962003 — TUAT SPLATTER CONTROL SHIELD SCS-300
- K962065 — 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE
- K962123 — AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM
- K962301 — STERNGOLD G-HARD METAL ALLOY
- K962302 — PEGASUS DENTAL ALLOY
- K962303 — STERNGOLD CF
- K962348 — PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT
- K962365 — XENON LIGHTSOURCE
- K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
- K954982 — KSEA SCALP BLOOD COLLECTION SET
- K960029 — HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT
- K961763 — PULSE*SPRAY INFUSION SYSTEM
- K962308 — EUB-905
- K951541 — IMX RUBELLA IGG
- K952969 — EIDOS 5003 HOLTER SYSTEM
- K960658 — COLLARLESS POLISHED TAPER HIP PROSTHESIS
- K961468 — QUIK-FIL VAPORIZER KEYED FILLER
- K961476 — SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
- K961649 — ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER
- K961650 — NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT
- K961701 — MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE
- K961775 — PROFORE FOUR-LAYER BANDAGE SYSTEM KIT
- K961988 — VALPROIC ACID EIA TEST
- K961997 — USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE
- K962406 — N CRP STANDARD SY
- K962410 — N PROTEIN STANDARD PY
- K946103 — TRUSTEX FLAVOR CONDON IN COLORS
- K951902 — PATHFINDER 700 HOLTER ANALYZER
- K952415 — DUREX, RAMSES, SHEIK
- K954900 — 3M RED DOT ECG LEAD WIRES A
- K955416 — CARDIMAX MODEL FX-2111
- K960725 — MARPP PRESSURE MONITORING SYSTEM
- K961036 — MBI FIBEROPTIC ENDO-ILLUMINATOR
- K961077 — PEP (POSITIVE EXPIRATORY PRESSURE) THERAPY DEVICE
- K961101 — STRYKER CEMENT REMOVAL SYSTEM
- K961118 — MAXIM PF MODELS 033-581/033-590
- K961316 — WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL
- K961673 — R&D RETIC-PG HEMATOLOGY CONTROL
- K961747 — ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)
- K961766 — WOUND HYDROGEL & STERILE WOUND HYDROGEL
- K961799 — NATURAL HIP SYSTEM - DRG HIP STEM
- K961846 — NEEDLE CATHETER
- K961926 — SANPOINT MENSTRUAL TAMPON
- K962182 — BURLEW INFANT HOOD
- K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
- K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
- K954559 — HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
- K960048 — EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP - PLUS
- K960073 — EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP
- K960258 — NATURAL HIP SYSTEM
- K960669 — HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
- K960803 — RX TEXTILES STERILE STOCKINETTE
- K961402 — STS SHIELD WITH MASK
- K961619 — DEPUY ENDURANCE CALCAR HIP PROSTHESIS
- K962355 — FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
- K962512 — BOSTON CONTACT LENS CASE
- K954163 — RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER
- K954772 — QUICKELS QS 200 SYSTEM
- K954773 — QUICKELS QS 100 SYSTEM
- K955045 — OMNI-TRAK PATIENT MONITORING SYSTEM
- K955755 — TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
- K955834 — SYSTEM 6500 ABC ELECTROSURGICAL UNIT
- K961562 — OSTEOMARK
- K961726 — ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
- K961758 — CARASYN HYDROGEL WOUND PRODUCTS
- K962056 — ADVANCED MICRO-OSMOMETER MODEL 3300
- K962373 — N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
- K962421 — SORBCEL ALGINATE/CMC WOUND DRESSING
- K954065 — BIODATA SR1 FAH-HCG ENZYME IMMUNOASSAY KIT
- K954290 — WALLSTENT ENTERAL ENDOPROTHESIS
- K955088 — NEOSONO 2000
- K955799 — COPALIS CMV TOTAL ANTIBODY ASSAY
- K955821 — I.V. ADMINISTRATION SETS
- K960769 — ACUPUNCTURE NEEDLE PACK
- K961133 — SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE
- K961243 — OCUSYSTEM ART ADVANTAGE
- K961296 — WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
- K961340 — NOVA LITE ANCA
- K961362 — AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE
- K961424 — INTRAN 500
- K961507 — WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
- K961555 — ACUFEX TAG BIOABSORBABLE ANCHORS
- K961578 — SUTURE ANCHOR
- K961579 — STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
- K961585 — SURGICAL DYNAMICS POP RIVET
- K961685 — P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)
- K961728 — MIRUSCONE ABUTMENT SYSTEM
- K961737 — CERA ONE ABUTMENT SYSTEM
- K961754 — SAFETY RELEASE MODULE
- K961818 — GENTAMICIN DISK (120MCG)
- K961819 — STREPTOMYCIN DISK (300MCG)
- K961913 — QUANTA LITE ENA 6 ELISA
- K961940 — INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP
- K962183 — BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
- K962523 — N LATEX CRP MONO REAGENT
- K955597 — MEDI-TRACE DEFIB PADS
- K955612 — RD-1200H NORMAL MODE RUBY LASER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.