FDA 510(k) clearances — page 1285
clearances on record, most recent first.
Clearances — page 1285
128,401–128,500 of 175,890- K895932 — PSG(TM) EDM(TM) INFUSION CATHETER
- K895935 — ICOR CMU Q PLUS
- K895961 — MODEL MC6500 ELECTROCARDIOGRAPH
- K896023 — OHMEDA 9000 SYRINGE PUMP
- K896065 — WALLACH CC/BRUSH
- K896076 — L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R)
- K896452 — KINEMAX TIBIAL STEM EXTENSION
- K896605 — KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG)
- K896606 — JACKSON FINE NEEDLE ASPIRATION SYSTEM
- K896615 — CINE CAMERA CONTROL MODEL PK2037
- K897120 — EQUIP COVERS, STERILE
- K890500 — ELT OR ERGONOMIC LIFT TRAINER
- K893622 — PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.
- K894226 — SILASTIC SOFT SHEETING
- K894722 — RENNER-PLAN
- K895417 — ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
- K895774 — GYN-PROBE
- K895874 — OPTILASE YAG MODEL 1000
- K896019 — MODIFIED DISP. CHIBA-TYPE NEEDLE DESIGNATED ASPI.
- K896192 — MEDISONIC PNEU-NEB
- K896311 — OPTEX BLOOD GAS MONITORING SYSTEM
- K896674 — AMSCO QUANTUM LIGHT
- K896904 — B.A.C. 3000 CHAIR/STANDER
- K896983 — SUNBRONZE SB24C/65 ULTRA
- K892779 — PATIENT EXAMINATION GLOVES
- K893254 — DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZER
- K894121 — PATIENT EXAMINATION GLOVES
- K895505 — KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
- K895660 — ANSELL DENTA GLOVES
- K895679 — CEFMATZOLE 30 MCG SENSI DISC
- K895760 — ELECTRICAL MUSCLE STIMULATOR--PGS 2000 TENS DEVICE
- K895797 — IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE
- K895860 — MEDI-PACK
- K895878 — OLYMPUS VALVULOTOME W/DETACHABLE TIP
- K896202 — MATRIX(TM)-96
- K896262 — TITANIUM LIGATING CLIPS
- K896416 — DYONICS SHOULDER PORTAL SYSTEM
- K896447 — AUTOSCEPTOR
- K896522 — DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY
- K896526 — LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
- K896553 — MEDX CERVICAL EXTENSION TEST & REHAB MACHINE
- K896604 — MAL LATEX EXAMINATION GLOVES
- K896640 — MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT
- K896692 — AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
- K896770 — ARTHRODISTRACTOR
- K896860 — OPUS CARBAMAZEPINE TEST SYSTEM
- K896868 — OPUS PHENYTOIN TEST SYSTEM
- K896947 — CHIROPRACTIC MASSAGE PILLOW
- K897025 — ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
- K897060 — CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
- K890349 — SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN
- K891986 — MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
- K894608 — MODEL 4000 EVOKED POTENTIAL MEASUREMENT SYSTEM
- K894949 — SQA
- K895864 — MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP
- K895917 — CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI
- K896105 — EVOLUTION HIP SYSTEM
- K896479 — ORTHO* RUBELLA-G ANTIBODY ELISA TEST
- K896643 — HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015
- K896962 — TINY HALOGEN EXAM LIGHT
- K885221 — MULTILUMEN CENTRAL VENOUS CATHETER
- K896058 — GRASPING FORCEPS
- K893461 — LATEX EXAMINATION GLOVES
- K894423 — ACC.U.DIAL
- K895012 — E-Z-EM VACUUM ASPIRATION SYRINGE
- K895139 — CLINISTAT HDL CHOLESTEROL REAGENT TEST
- K895290 — CHEMO-SPIKE RECONSTITUTION DEVICE
- K895291 — IV DISPESNSING SPIKE
- K895426 — AMBULATORY INFUSION PUMP
- K895465 — AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
- K895516 — CAVITY DRAINAGE CATHETERIZATION SET, CS-01600
- K895689 — LIFEPORT VASCULAR ACCESS PORT
- K895755 — MIKRO-LAVAGE-1
- K895756 — MIKRO-AQUAPURATOR
- K895802 — NON CONSTRAINED TOTAL SHOULDER SYSTEM
- K895865 — SERENE WRAP
- K895883 — BECKMAN MA MICROALBUMIN REAGENT KIT
- K895884 — BANDAGE REMOVAL STRIP
- K895943 — NORMAL AND ABNORMAL CONTROL SERA
- K896003 — LATEX EXAMINATION GLOVES
- K896006 — DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
- K896008 — MODEL 6500 MERCURY ARC LIGHT SOURCE
- K896111 — FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB
- K896145 — ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY
- K896191 — SUNTANNING BED, INC. T12 UVA TANNING LAMPS
- K896390 — WILSON-COOK ESOPHAGEAL PROSTHESIS
- K896584 — ARTHROSCOPIC TUBING SHEATH
- K896589 — MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP
- K896593 — BECTON DICKINSON RATE INFUSER II SYSTEM
- K896641 — MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT
- K896774 — STREAMLINE VASCULAR ACCESS DEVICE
- K896792 — SURGICAL SKIN MARKER
- K896801 — LAP SPONGE
- K896802 — MAGNET PAD
- K896803 — CLOSED WOUND RESERVOIR
- K896831 — ALISUN SUNTANNING BED
- K895814 — MICROTEK PISTON & WIRE PROSTHESES
- K895815 — MICROTEK TOTAL OSSICULAR PROTHESIS
- K895876 — RAMVAC DENTAL VACUUM SYSTEM
- K895877 — RAMCLEAN DENTAL VACUUM LINE CLEANER
Data sourced from openFDA. This site is unofficial and independent of the FDA.