FDA 510(k) clearances — page 1647
clearances on record, most recent first.
Clearances — page 1647
164,601–164,700 of 175,890- K810639 — SERALYZER SYSTEM
- K810651 — ORAL AIRWAYS
- K810652 — TUBING CONNECTORS
- K810658 — RPR CARD TEST SYSTEM
- K810659 — AUTODILUTER III
- K810662 — LEECO LH-QUANT DIAGNOSTIC KIT
- K810664 — ISOLATOR SYSTEM
- K810667 — AMERLEX ESTRIOL RIA KIT
- K810669 — PANTRAK E.K.
- K810673 — ENZYMATIC CHOLESTEROL
- K810674 — GLUCOSE OXIDASE
- K810680 — ENZYMATIC TRIGLYCERIDE
- K810695 — ESTRIOL RADIOIMMUNOASSAY TEST KIT
- K810717 — COAT-A-COUNT T3 UPTAKE KIT
- K810718 — C-PEPTICE REAGENTS
- K810724 — CORNING 178 BLOOD GAS ANALYZER
- K810725 — QUALITROL #65057
- K810727 — AST-UV (PLP-ACTIVATED) DETERMINATION
- K810736 — LUMINESCENCE PHOTOMETER 100 SERIES
- K810738 — GOODE MAGNETIC NASAL SPLINT
- K810741 — LUTEINIZING HORMONE
- K810742 — AQUEOUS TRIOLEIN STANDARDS & KITS
- K810743 — LECITHIN-SPINGOMYELIN STAND. & KITS
- K810745 — DOUBLE LUMEN SUBCLAVIN CATHETER SC-400
- K810753 — AIRWAY PRESSURE MONITOR
- K810754 — LUTENIZING HORMONES
- K810787 — UROLOGIC TUBE HOLDER
- K810791 — PENTAX COLONOSCOPE MODEL FC-34 MA
- K810225 — LITRONIC STIMULATOR
- K810570 — DRESSING CHANGE TRAY-MEDIUM
- K803270 — GANZ CORONARY REPERFUSION CATHETER
- K810113 — TERFUSION FINAL FILTER SET
- K810204 — 17B ESTRADIOL
- K810352 — SWAN-GANZ FLOW-DIRECTED THERMODILUTION
- K810619 — 710 FLUOROMETER/DENSITOMETER
- K810625 — HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-
- K810631 — DPM CALCULATOR
- K810653 — VINYL ICE BAG
- K810654 — STOPPERLESS HOT/COLD RUBBER WATER BOTTLE
- K810661 — CATHDAMP
- K810663 — LEECO FSH-QUANT DIAGNOSTIC KIT
- K810675 — ARROW RADIAL ARTERY CATHETERIZATION SET
- K810696 — PHYSIOLOGIC RECORDER
- K810730 — MODEL SP5107 THERMODILUTION CATHETER
- K810731 — MODEL IM1000 INTEGRATED MONITOR
- K810732 — LINDE MARK II OXYGEN RESERV. TYPE OR-4
- K810750 — PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
- K810763 — OHIO DISPOSABLE TRACHEAL TUBE
- K810027 — DATAMEDIX PECGASYS SYSTEM
- K810050 — VECAFIX*
- K810114 — VASCULAR ACCESS SYSTEM
- K810154 — LIFEPAK 7 ACUTE CARDIAC CARE SYSTEM
- K810475 — HELENA HEMOGLOBIN F CONTROLS
- K810520 — INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL
- K810579 — ADHESIVE I.V. CATHETER DRESSING
- K810623 — BAND-AID KITCHEN ASSORTMENT
- K810633 — WONDER WARMER
- K810649 — INVALID CUSHION
- K810650 — CRUTCH TIPS & GRIPS
- K810676 — CONVAID CRUISER CP4M
- K810681 — MEDI-LANCE
- K810685 — SUTURE REMOVAL KIT
- K810692 — CURITY PERINEAL WARM PACK
- K810693 — CURITY PERINEAL COLD PACK
- K810517 — INSTA-BOND
- K810518 — CAST HIPPED VITALLIUM
- K810530 — PERI-PATCH GLUE MOLD
- K810531 — PERI-PATCH PERITONEAL CATHETER EXTENSION
- K810545 — PCA PERIOCARE PERIODONTAL DRESSING
- K810585 — SARA
- K810587 — EMIT-TFG PRISMA THYROXINE CALIBRATORS
- K810594 — CRYSTALLOY-P
- K810595 — SILUX RESTORATIVE MATERIAL & ENAMEL BOND
- K810600 — CAPD EXCHANGE SET
- K810611 — FULCAST/SUMMIT CASTING ALLOY
- K810644 — HOFFMAN HOOP DEVICE
- K810670 — CCPD CYCLER SET
- K810671 — CCPD 3 LITER DRAINAGE SET
- K810712 — ELECTRONIC SPIROMETER MODEL MFR-8100
- K810784 — FUNGIZONE
- K802478 — CYBER 120 HEMODIALYZER
- K803247 — TRANSCUTANEOUS ELECT. NERVE STIMULATOR
- K810175 — NEO NATAL RESPIRATION FUNCTION BLOCK
- K810187 — AUTO SUTURE PSS SKIN STAPLING INSTRUMENT
- K810188 — AUTO SUTURE GAS POWERED DISP. LDS STAPL
- K810193 — TRIPPI-WELLS DUAL PURPOSE UNIVERSAL TONG
- K810206 — DUAL TYPE ELECTRODE
- K810248 — MSI BONE MARROW BIOPSY NEEDLE W/J TIP
- K810295 — COMPUTER INTERFACE MODULE
- K810315 — ALTERNATE STERILIZ. FOR CELLULOSE ACET
- K810324 — AUTOMATIC HEMOCLIP APPLIER, 527700
- K810331 — DUO-TEL
- K810335 — RESPIRIZER
- K810336 — POLYPECTOMY SNARE
- K810358 — PHOTOTHERAPY LIGHT CHAMBER
- K810367 — KISH URETHRAL ILLUMINATED CATHETER SET
- K810368 — VANCE PERCUTANEOUS MALECOT NEPHROSTOMY
- K810370 — POLLACK CHAIN CYSOURETHROGRAM SET
- K810371 — VANCE URETHAL DILATOR SET
- K810372 — VANCE DEFLECTABLE BIOPSY BRUSH SET
Data sourced from openFDA. This site is unofficial and independent of the FDA.