FDA 510(k) clearances — page 1286
clearances on record, most recent first.
Clearances — page 1286
128,501–128,600 of 176,637- K900115 — VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B
- K900237 — MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID
- K900238 — MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID
- K900588 — ACU-BAND ACCUPRESSURE WRIST BAND
- K900738 — BOOSTER MOTORIZED THREE WHEELED VEHICLE
- K897156 — HYDRASORB(TM)
- K900108 — 3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12
- K900244 — 3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8
- K900476 — WOODLYN SLIT LAMP MODEL HR-1
- K900477 — WOODLYN CLASSIC SLIT LAMP MODEL SMM
- K900478 — WOODLYN FULL APERTURE TRIAL LENS SET
- K895301 — EMS 8100
- K895654 — SORBEX(TM) SOFT SPONGE
- K895690 — ULTRA (THERAPEUTIC ULTRASOUND DEVICE)
- K895983 — MULTISTIM PLUS
- K896727 — 4 SURE URINARY DRAIN BAG
- K896728 — 4 SURE URINARY LEG BAG
- K896814 — TOI-LIFT
- K896836 — EXCEL STIM
- K896908 — EXCEL STIM II
- K900290 — SKYTRON MODEL 1100 AND MODEL 142
- K900581 — DANNIFLEX CPM 880(TM)
- K900600 — TRI-SCOOT FRONT WHEEL DRIVE POWERED SCOOTER
- K893545 — IVEX MODEL NO. BP 3000 BREASTPUMP
- K894734 — RHINOTHERM ULTRA 2
- K895018 — SURGICAL GLOVES
- K895335 — CRONEX COMPACT MAMMOGRAPHY CASSETTE
- K895768 — EXEL SAFELET CATHETER
- K895769 — EXEL HUBER NEEDLE
- K895771 — EXEL SPINAL NEEDLES
- K895772 — EXEL INDWELLING CATHETER
- K895890 — AUTOPEN
- K895951 — CHOLESTEROL TEST KIT
- K896095 — IMAGES-ON-CALL TELERADIOLOGY SYSTEM
- K896160 — WILLIAMS PENILE ANESTHETIC RETAINER
- K896170 — REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
- K896227 — COBAS READY URIC ACID REAGENT
- K896228 — COBAS READY CARDIO PROFILE REAGENT STRIP
- K896229 — COBAS READY PROFILE 1 REAGENT STRIP
- K896230 — COBAS READY TOTAL PROTEIN REAGENT
- K896231 — COBAS READY TRIGLYCERIDE REAGENT
- K896233 — COBAS READY LIVER PROFILE REAGENT STRIP
- K896234 — COBAS READY STAT PROFILE REAGENT STRIP
- K896237 — COBAS READY ALT REAGENT
- K896238 — COBAS READY AST REAGENT
- K896239 — COBAS READY CHOLESTEROL REAGENT
- K896240 — COBAS READY CK REAGENT
- K896241 — COBAS READY LDH REAGENT
- K896265 — QUIDEL GROUP B STREP TEST
- K896440 — KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT
- K896521 — MODIFIED PARAMAX URIC ACID REAGENT
- K896567 — CANTATA EMG/EVOKED RESPONSE SYSTEM
- K896587 — MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT
- K896613 — FLAT VASCULAR PROBE
- K896623 — SAFECON CONDOMS - PINK COLOR
- K896666 — P460, DG32 ELECTROENCEPHALOGRAPH
- K896725 — 4 SURE UROLOGICAL CATHETER
- K896762 — SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY
- K896784 — DISPOSABLE URODYNAMIC CATHETER SET
- K896797 — SUCTION CATHETER KIT
- K896845 — RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
- K896935 — CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE
- K896949 — MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS
- K897065 — PORT INFUSION SET (PIS) INFUSION SET (IS)
- K897099 — MODEL 2800 ND:YAG OPHTHALMIC LASER
- K900063 — MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)
- K900070 — MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM
- K900131 — BIO FLOTE(R)
- K900161 — A-SCAN ROLL-AROUND STAND
- K900162 — DGH A-SAN PROBE HOLDER
- K900280 — CENTRIPREP 100
- K900448 — CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN
- K896455 — VITACHOICE WOUND DRESSING
- K896542 — ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM))
- K896543 — ULTRAMARK 7 ULTRASOUND SYSTEM
- K896549 — STORZ FIBEROPTIC ENDO-ILLUMINATORS
- K896579 — GOOSEN URINARY DRAINAGE SYSTEM
- K896580 — UNI-POLAR HEAD
- K896636 — RMI ANTEPLEGIA CANNULA
- K897034 — K-SPONGE
- K897045 — BOWIE-DICK TEST CARD CATALOG NUMBER 008018
- K897179 — ORBITER(TM) TREADMILL
- K897192 — TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
- K900307 — KARE CHAIR I
- K900330 — QUICKIE P300 WHEELCHAIR
- K900355 — MARK VII THERMOREGULATION ASSIST SYSTEM
- K900417 — WHEELCHAIR LIFT (WHEELCHAIR ELEVATOR)
- K900439 — SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC
- K900565 — INVACARE POWER 9000 SERIES WHEELCHAIR
- K893736 — HOT BRUSH
- K895066 — MONOGRAM IV
- K895283 — PROSTHETIC RESTORATION DEVICE
- K896602 — FD5000 DENTAL CHAIR
- K896653 — SEPARATING MEDIUM (POLYVINYL ALCOHOL)
- K896654 — DRYING AGENT
- K896655 — 9.6% HYDROFLUORIC ACID GEL
- K896656 — ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH
- K896657 — ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA
- K896658 — DENTIN DISCLOSING GEL AND GEL REMOVER
- K896659 — SILANE
Data sourced from openFDA. This site is unofficial and independent of the FDA.