FDA 510(k) clearances — page 1084
clearances on record, most recent first.
Clearances — page 1084
108,301–108,400 of 175,890- K936016 — QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
- K940840 — ACT CONTROL SET
- K940971 — AMES DCA 2000 HEMOGLOBIN ALC CONTROLS
- K941932 — SPLASH MASK
- K941984 — SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP
- K942356 — MED-EVAC-4 MEDICAL EVACUATION STRETCHER
- K942526 — SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM
- K942691 — LORREX POST OPERATIVE SPONGES
- K942879 — DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH
- K942886 — SIMPULSE SOLO SUCTION IRRIGATOR
- K942896 — CLAMPS AND CLIPS
- K942957 — O-R-EZ TIP CLEANER
- K931651 — NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW
- K932291 — EUTRA GEL FOR WOUND DRESSING
- K932482 — MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010
- K933227 — UNI-FRAME HEAD IMMOBILIZATION SYSTEM
- K933672 — XOMED-TREACE SCOPESHEATH
- K934484 — QUICKVUE IN-LINE ONE-STEP STREP A TEST
- K935300 — VAC-LOK IMMOBILIZATION SYSTEM
- K935411 — MED-TEC, INC. BREAST BOARD, MT-250
- K935412 — MED-TEC, INC. BREAST BOARD, MT-200
- K935951 — KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM
- K936010 — THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
- K936282 — TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)
- K940289 — ABBOTT PRISM ANALYZER
- K940373 — OPHTHALMIC CRYO UNIT
- K940416 — NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
- K940540 — VELO ACE
- K941169 — TEC 2101 (MODEL MT-HPLGD)
- K941264 — RICHARD ROD LENS LARYNGOSCOPE
- K941447 — SIMPLA S4, S5, S7
- K941489 — ACE CLINICAL CHEMISTRY SYSTEM
- K941705 — NERVE FIBER ANALYZER
- K941714 — CHLAMYDIA TRACHOMATIS ANTIGEN TEST
- K941719 — 360 DEG. ROTATING 1/2 BEAM BLOCK
- K941773 — MEDICAM 900 REMOTE
- K942066 — ACS HI-TORQUE EXTRA S'PORT GUIDE WIRE
- K942120 — ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION
- K942282 — MED-TEC BREAST SUPPORT SYSTEM
- K942573 — COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH
- K942749 — HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT
- K942876 — IMPLANTECH DORSAL NASAL IMPLANT
- K913601 — MICROPHOR
- K915444 — DUPEL IONTOPHORESIS DEVICE
- K925038 — PACING LEAD MODEL 1188T
- K930431 — ARTHROSTIM MANIPULATOR
- K936072 — NON-PRESCRIPTION SUNGLASSES
- K936302 — NIDEK MODEL VT-4000, MODIFICATION
- K941495 — RETURN PATH DIATHERMY HANDLE
- K942119 — U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES
- K942513 — SEIKO EYEGLASS FRAME
- K942642 — SURGI-WIPE
- K942783 — NON-PRESCRIPTION SUNGLASSES
- K925800 — RH-806, MODEL TRANSQ
- K925806 — RH-801, MODEL TRANSQ
- K930044 — COMFORT KEYBOARD SYSTEM
- K934167 — IPI DUAL LUMEN PORT
- K934796 — IPI LOW PROFILE IMPORT
- K936229 — AIA-PACK TT3 ASSAY
- K940980 — CHARGED SUPOR(R) FILTER EXTENSION SET
- K941315 — STANBIO Y-GT (LIQUICOLOR) TEST SET
- K941498 — BIOMEK SL WITH BIOMEK SL INCUBATOR
- K941645 — BIOPSY TRAY
- K941850 — IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE
- K941940 — IMMOBILE STERILE AND IMMOBILE A/C STERILE
- K942181 — SOF-SET QR INFUSION SETS, MODELS MMT-115 AND MMT-116
- K942430 — AGALLOY, DISALLOY, EPSILON AND LAMBDA
- K922702 — PROVIDER ANNE INFUSER
- K932056 — DEFEND SELF-SEALING STERILIZATION POUCH
- K933194 — THE SIGNATURE SERIES, IMC IV
- K934500 — METASYS AMALGAM SEPARATOR MST1
- K934589 — KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED
- K935206 — KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION
- K935272 — CAP 400 AT
- K935453 — CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM
- K935784 — PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM
- K935818 — ENDOSCOPE
- K935990 — F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM
- K936166 — CHEMTRAK LIQUID UNASSAYED THERAPEUTIC DRUG CONTROLS
- K940569 — DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET
- K941256 — QUICK CORE II
- K941816 — EMC FLEXIBLE BIOPSY FORCEPS
- K942043 — DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E
- K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY
- K942192 — THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS
- K942492 — ADJUSTABLE BITE CORRECTOR
- K942699 — AIRFRAME SURGICAL DRAPE SUPPORT
- K942779 — DISPOSABLE BACTERIOLOGICAL FILTER
- K942892 — CONMED SELECT-ONE LAPAROSCOPIC ELECTROSURGICAL BLADE
- K924112 — HYDROXYLAPATITE COATED SABER TECH SERIES I & SERIES II
- K925355 — BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST
- K925596 — NON-PRESCRIPTION SUNGLASSES
- K926597 — LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
- K930613 — HOOKING SYSTEM
- K931468 — RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM
- K933196 — THE SIGNATURE SERIES, IC II
- K933881 — DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
- K935167 — OGDEN ANCHOR (MODIFICATION)
- K936143 — ISOCOMFORTER
- K936280 — GALILEO ARTHROSCOPES
Data sourced from openFDA. This site is unofficial and independent of the FDA.