FDA 510(k) clearances — page 975
clearances on record, most recent first.
Clearances — page 975
97,401–97,500 of 175,890- K963134 — DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
- K955887 — NEWMED ABP-LITE
- K960578 — ELVIS HSV GOLD
- K960860 — GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3
- K961105 — SKIN DOSE MONITOR
- K961261 — DYNATRON 525
- K961525 — ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
- K961594 — BETTER-VENTER
- K961628 — MINI FLEX COIL
- K961969 — HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE
- K961985 — ELECT BLOOD GLUCOSE MONITORIG SYSTEM
- K962237 — THUMPER CARDIOPULMONARY RESUSCITATOR
- K962275 — MAICO MA25 SERIES II WITH SPEECH
- K962300 — CLAMPLESS VALVED CATHETER
- K962361 — TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND
- K962484 — SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)
- K962499 — ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
- K962710 — GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS
- K962711 — GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS
- K962910 — SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY
- K963152 — RIONET HB-55AS
- K963153 — RIONET HB-55S
- K963154 — RIONET HB-54AS
- K955788 — IMNI HOT PACKS
- K960194 — MYELOTEC MYELOSCOPE
- K961053 — SERAQUEST RUBELLA IGG
- K961176 — OMNI COLD GEL PACKS
- K961597 — GATED MIBI 3-D EJECTION FRACTION PROCESSING
- K961991 — ACL 6000 SYSTEM (ACL 6000)
- K962177 — BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT
- K962375 — MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
- K962519 — EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
- K962595 — KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS
- K962618 — GYREX V-EP
- K950025 — SELF PROPELLED ROBOTIC WHEEL (SPRW)
- K960785 — LFS LIPOGEL ASSAY KIT
- K961410 — DURASIL (MODIFICATION)
- K962192 — SUNRISE CURING LAMP
- K962242 — SURESCAN
- K962315 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT
- K962377 — 3D-SPINE
- K962383 — PULPDENT RESILUTE II
- K962401 — GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES
- K962439 — DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)
- K962496 — SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)
- K962616 — SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM
- K962935 — UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE
- K962946 — ORTHO-ONE
- K963093 — SIREMOBIL COMPACT
- K953873 — VARELISA HELICOBACTER PYLORI ANTIBODIES
- K954607 — RETICULOCYTE METHOD
- K955586 — ROBISON & SMITH SURGICAL PACKS
- K955895 — E. HISTOLYTICA TEST
- K960857 — GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR
- K960858 — GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
- K961697 — OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
- K962020 — S-41 & S-41S VIDEO IMAGING SYSTEM
- K962044 — VALLEYLAB COATED ELECTRODES
- K962231 — COBAS CORE IMMUNOCHEMISTRY SYSTEM
- K962272 — SYNTHES MANDIBLE DISTRACTOR
- K962549 — VIDAS CREATINE KINASE MB ASSAY 30-421
- K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD
- K962672 — ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
- K962758 — DSL 9100 IGF-II IRMA
- K962794 — ETEST FOR AZTREONAM
- K962885 — SEALEX EXTRA ROOT CANAL SEALER
- K963165 — ELECSYS CALCHECK HCG
- K935512 — CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE
- K955672 — TROJAN POLYURETHANE CONDOM (MODIFICATION)
- K960003 — STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION
- K960263 — CERVICAL MUCOUS ASPIRATION CATHETER
- K960549 — MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE
- K961702 — KSEA VAPORIZATION ELECTRODES
- K961860 — A4907 LENS CLEANING SHEATH
- K962097 — VENTRICULAR CATHETER SET
- K962106 — SPLINE DENTAL IMPLANT SYSTEMS
- K962115 — CAMBRIDGE HEART HI-RES ECG ELECTRODE
- K962135 — D.O.R.C. MICRODIATHERMY SYSTEM
- K962248 — P.F.C. CERAMIC HIP HEAD
- K962259 — LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
- K962289 — SELECT SHOULDER COCR HUMERAL STEM COMPONENT
- K962306 — FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES
- K962311 — FRESHFROZENCELLS
- K962371 — DERMTOME BLADE
- K962405 — SANICURE DISPOSABLE CURING PROBE
- K962580 — EZ SURE ONESTEP EARLY PREGNANCY TEST
- K962780 — FRESHCELLS, HEP-2
- K962782 — FRESHFROZEN CELLS, HEP-2
- K962975 — PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)
- K963240 — IMMULITE ACTH CONTROL MODULE (LACCM)
- K951128 — MEDILOG STRESSLINK
- K954623 — REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNECTOR)
- K960700 — LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM
- K960933 — BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
- K960971 — OCULIGHT GL
- K962156 — 3304 PULSE OXIMETER
- K962193 — PORTLAND TROCARS
- K962224 — SELECT SHOULDER CONCENTRIC HUMERAL HEAD COMPONENTS
- K962228 — MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT
- K962553 — EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.