FDA 510(k) clearances — page 1334
clearances on record, most recent first.
Clearances — page 1334
133,301–133,400 of 175,890- K890030 — NEW LOW LEVEL DRUG MIXTURE CONTROL
- K890041 — V-TREND TARGET IM TEST
- K882609 — MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM
- K883905 — ARROW PNEUMOTHORAX KIT, AK-01500
- K884434 — VORTECH'S MEDICAL IMAGING GATEWAY
- K884464 — SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR
- K884472 — AIR-ELECTRONIC AIR CLEANER (FILTER)
- K884540 — ETV, ELECTRONIC VISION AID
- K884615 — ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK
- K884653 — RACESTYPTINE
- K884752 — KETAC-GLAZE
- K885217 — DISCARD DENTAL EXPLORER
- K885218 — DISCARD DENTAL MIRROR
- K885219 — DENTAL DRESSING PLIERS
- K884410 — OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM
- K884483 — CRUCIOMETER
- K884500 — ALTA NON-REAMED TIBIAL ROD
- K884502 — USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
- K884583 — BTE HEARING AID SIEMENS MODEL 284PP-ASP
- K884670 — EXEL 1800 AND 1800E CT SCANNER
- K884671 — EXEL 2400 AND 2400 ELITE CT SCANNERS
- K885346 — NON-STERILE VINYL GLOVES
- K881323 — CURIETRON 192 LOW DOSE RATE
- K882824 — TAKEDA MEDICAL AUTO. DIGITAL BLOOD PRES. MONITOR
- K882825 — TAKEDA MEDICAL AUTO. DIG. BLOOD PRES. METER W/PRIN
- K883069 — MINIMON 7134B PATIENT MONITOR
- K883109 — MINIMON 7136B PATIENT MONITOR
- K883214 — THORACIC SUPPORT SYSTEM
- K883402 — EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER)
- K883440 — E550 ELECTROCARDIOGRAPH
- K883743 — MEDTRONIC MODEL 4058 PACING LEAD
- K884135 — DM100 (DISTAL MONITOR - 100)
- K884158 — THE SYSTEM, SARA DIGICAP PLUS OHMEDA MINX OXIMETER
- K884398 — OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
- K884440 — TECNOL VARIABLE TENSION BANDAGE
- K884484 — MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL
- K884490 — INTRODUCER SAFETY SYRINGE
- K884520 — SERVO VENTILATOR 900E
- K884539 — HOLTER 24-HOUR ECG PLAYBACK, MODEL 150
- K884663 — IMPULSE EPIDURAL ELECTRODE
- K884678 — ESP 3-PHASE X-RAY GENERATORS
- K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
- K884708 — FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT
- K884730 — SHILEY PERC TRACHEOSTOMY SYSTEM
- K884769 — MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
- K884948 — MODEL 3587A RESUME EPIDURAL LEAD
- K884973 — FR6000 FLOWMETER
- K885022 — MAGNESIUM TEST ITEM NUMBER: SR1019
- K885033 — MODEL 3487A PISCES EPIDURAL LEAD
- K885314 — HPD STERILE HUMIDIFYING CHAMBER
- K881314 — PROMO-RIST C.P.M.
- K882344 — ELECTR-TRANSBLOTTER
- K882633 — ENSONIQ SOUND SELECTOR, BTE DIGITAL PROG. HRNG AID
- K883373 — STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT
- K883544 — LYME FAST TEST
- K883727 — BUCKET PROSTHESIS PORP
- K883750 — VENTRALITH I
- K884421 — PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT
- K884516 — FITC MURINE MONOCLONAL ANTI-RSV IGG
- K884616 — FIRSTDAY EARLY PREGNANCY TESTING KIT II
- K884632 — ACUSON I5100 ULTRASOUND TRANSDUCER
- K884756 — CLINISTAT GLUCOSE REAGENT TEST
- K884880 — PREGNAGEN(TM)
- K884900 — SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER
- K884911 — CORTRONIC SCR1000
- K884986 — CALCIUM TEST ITEM NUMBER: SR1009
- K884987 — UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
- K884988 — GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
- K885049 — RS-CUP ACETABULAR PROSTHESIS
- K885100 — MCCONNELL REAMER GUIDE
- K885199 — #500 SERIES FORCEPS W/CUT/COAGULATE SWITCHES
- K885200 — 600 & 900 SERIES ELECTRODES & 755 & 756 HANDLE
- K885215 — LINCOLN MILLS HIP HOLDER
- K885252 — MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001
- K890042 — MICROSCOPE SLIDES PRECOATED
- K881771 — SENSOCOR(TM) DIASYS
- K884065 — CATH LAB MONITORING CATHETER
- K884083 — TORAY VASCULAR PROSTHESIS
- K884401 — SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT
- K884408 — NAMIC DUAL BACKCHECK VALVE
- K884451 — DOPCORD PPG
- K884493 — HEAD HOLDING DEVICE/SLEEP APNEA
- K884647 — USCI ADJUSTABLE TIP GUIDE WIRE
- K884685 — ROCKET FETAL BLOOD SAMPLING TRAY
- K884781 — OPTI-POINT
- K884992 — FUKUDA DENSHI MODEL FX-1201
- K885088 — THAYER FLEXIBLE CONDENSATE COLLECTION SYSTEM
- K885101 — MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
- K885171 — MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
- K884189 — KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC)
- K884254 — CIRCON ACMI BICAP III THERAPEUTIC SYSTEM
- K884375 — TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
- K884376 — ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
- K884382 — AMYLASE TEST (AMYL) ITEM NUMBER: 65653
- K884531 — BETA 90/50 MOBILE IMAGING TABLE
- K884581 — RELIANT OXYGEN CONCENTRATOR
- K884705 — ALBUMIN TEST (ALB) ITEM #65650
- K884706 — CHLORIDE TEST (CL) ITEM #65659
- K884923 — MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM)
- K885067 — 4060 HA PARTICLES
Data sourced from openFDA. This site is unofficial and independent of the FDA.