FDA 510(k) clearances — page 1419
clearances on record, most recent first.
Clearances — page 1419
141,801–141,900 of 175,890- K864206 — REVEAL COLOUR STREP A ZL16
- K864385 — LUXTEC LIGHT SOURCES
- K864612 — DART PHENOBARBITAL ASSAY SYSTEM
- K864635 — FOUR TANK DISSOLUTION MODULE
- K864742 — UREA NITROGEN(BUN), COLORIMETRIC METHOD
- K864743 — BIURET (COLORIMETRIC), TOTAL PROTEIN
- K864744 — CREATINE PHOSPHOKINASE (CK)
- K864863 — DYNALUME(TM) REMOVAWELL STRIPS (NO. 011-010-7403)
- K864905 — ALKALINE PHOSPHATASE
- K865075 — H-H SUBGALEAL TROCAR
- K865102 — IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
- K860036 — EDP-20 PACEMAKER
- K862085 — ARKIVE (TM)
- K863154 — HEATED JET HUMIDIFIER MODEL AMS-1020
- K863410 — PATIENT VALVE WITH AIR ENTRAINMENT
- K863801 — TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR
- K863959 — OHMEDA 6000 MULTI-GAS MONITOR
- K864009 — MINGOGRAF 410
- K864218 — PROCON
- K864233 — BARD HARVARD MINI-INFUSER 950 PUMP
- K864431 — PEDIATRIC BELLOWS
- K864472 — PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK
- K864536 — OHMEDA 5500 AIRWAY PRESSURE MONITOR
- K864547 — BIRD 6500 AIR COMPRESSOR
- K864670 — BOARD, ARM (WITH COVER)
- K864688 — ARNOLD-KING PRESSURE DRESSING
- K864829 — MODEL NS-3CC NEURO-STIM PERIPHERAL NERVE STIMULAT
- K864830 — TEFLON-COATED HYPODERMIC NEEDLES/REGIONAL BLOCK
- K864897 — DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
- K864919 — SCANLAN (TM) VEIN/GRAFT HOLDER
- K864920 — SCANLAN (TM) INSTRUMENT TRAY
- K865016 — BLOOD LANCET
- K865022 — SURGICAL GARMENTS
- K865023 — COVER, SHOE OPERATING ROOM
- K865024 — ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER
- K865033 — BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER
- K865100 — TISSUE-EQUIVALENT BREAST SIMULATOR
- K870048 — ADDITIONAL MODEL TO CANON UNIVERSAL STAND
- K861202 — TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS
- K862865 — MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE
- K862866 — MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE
- K863947 — SONOLAYER-L, SAL-77B
- K863999 — VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042
- K864267 — SEP-PAK CARTRIDGES (LIQUID CHROMATOGRAPHY)
- K864277 — UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS
- K864285 — TERUMO OVATION SPECTROPHOTOMETER
- K864312 — IC MICROASSAY
- K864323 — CYTOLOGY BRUSHES
- K864336 — PACHYMETER SYSTEM V
- K864373 — CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
- K864546 — MAXI-TAN DEVICE
- K864680 — MOBIL 02
- K864741 — CRESOLPHTHALEIN COMPLEXONE, CALCIUM
- K864850 — WAKO(TM) AUTOKIT GPT
- K864865 — SPECULUM, VAGINAL, METAL FIBEROPTIC
- K864894 — EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
- K864966 — ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
- K864974 — GENERAL PURPOSE CENTRIFUGE
- K865014 — LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
- K864553 — EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
- K864607 — EASY-TEST QUINIDINE ITEM NO. 67---/95
- K864675 — MODEL FORCE 4B ELECTROSURGICAL GENERATOR
- K864785 — AMOENA BREAST FORMS
- K864786 — PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
- K864816 — CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE
- K864851 — MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR
- K861514 — VNA OPTICAL CORRELATOR
- K862286 — ARTHROPHONOMETER
- K862315 — FYODOROV COLLAGEN CORNEAL SHIELD
- K862916 — EZ-SCREEN: CANNABINOID
- K863610 — THE OB-GYN CONCEPTS VAGINAL ASPIRATOR
- K863918 — MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.
- K864321 — MICRO-VENT
- K864346 — REMBRANDT PORCELAIN TINTING KIT
- K864527 — DUOCEPH
- K864554 — EASY-TEST PRIMIDONE ITEM NO. 67---/95
- K864677 — TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP
- K864925 — EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
- K864926 — EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
- K861188 — SPERM CAPACITATION MEDIUM
- K861241 — ANGIOTOPO CATHETER
- K862051 — MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
- K862055 — CANWEST OVU-BLUE
- K863153 — MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH
- K863369 — MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES
- K863535 — LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.
- K863536 — MEDTRONIC MODEL 5013
- K863684 — URESIL SUBCLAVIAN CATHETER
- K863705 — COMPUTER CONTROLLED EXTENSION (CCX)
- K863855 — ACCUSAT
- K863904 — DISPOSABLE ECG MONITORING ELECTRODE
- K863914 — MODIFICATION TO DYNASCOPE SERIES MONITORS
- K863916 — CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM
- K863917 — CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.
- K863936 — DUFFY BOLUS INJECTOR
- K864062 — PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)
- K864153 — PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290
- K864330 — SHEAR FORCE GAUGE
- K864331 — TRI-LOCK LONG STEM MODULAR NECK
- K864352 — MODIFIED PEEL-AWAY INTRODUCER SET LINE
Data sourced from openFDA. This site is unofficial and independent of the FDA.