FDA 510(k) clearances — page 1460
clearances on record, most recent first.
Clearances — page 1460
145,901–146,000 of 175,890- K860029 — LDH (OPTIMIZED) REAGENT
- K860052 — QWIK-CALL
- K860109 — ENZYMATIC UREA NITROGEN REAGENT SET
- K860134 — EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
- K860140 — STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
- K860154 — BUN (ENZYMATIC BERTHELOT) REAGENT SET
- K860159 — THUMPER (VIBRATOR/MASSAGER)
- K860227 — POWERED TRACTION EQUIPMENT
- K860301 — RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE
- K852955 — HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD
- K853027 — TECHNICON H*1 SYSTEM (MPXI)
- K853030 — TECHNICON H*1 SYSTEM (HDW)
- K853390 — INFANT BODY TEST
- K853409 — SCREENMATE
- K853434 — ERGO-PNEUMOTEST
- K853484 — INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT
- K854569 — HEMOR-ICE
- K854577 — PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)
- K854666 — CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
- K855068 — SPIROMETER, MODEL TS-500 PART #SLZ7534
- K855144 — TOURIQUET KIT WITH SNARE
- K855205 — MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM
- K860056 — BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)
- K860060 — RX02 PLUS OXYGEN CONCENTRATOR
- K860063 — ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM
- K860152 — MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY
- K860230 — CAPD TRANSFER SET SPIKE 5C4363
- K860241 — JMS AV FISTULA NEEDLE
- K860282 — RPMI 1640 W/GLUTAMINE W/HEPES
- K860292 — CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000
- K860293 — CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS
- K860302 — PYR DISCS
- K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY
- K853841 — HARMO SONIC
- K854227 — FASCILULATED NAIL
- K854312 — ASSERACHROM IX:AG
- K854361 — CO2 LASER LAPAROSCOPE SYSTEM
- K854384 — ASSERACHROM FPA KIT
- K854466 — BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER
- K854488 — ORTHO HSV ANTIGEN ELISA TEST
- K854505 — CARDIMAX FX-406U
- K854508 — STORZ DAISY
- K854539 — UROSTAT
- K854547 — MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE
- K854548 — MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES
- K854549 — MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU
- K854587 — STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE
- K854588 — INSTA-GLAZE
- K854593 — NORFOLK MEDICAL PERITONEAL-ACCESS PORT
- K854754 — PATIENTMATE TM
- K854818 — SUNGLASSES
- K854832 — EVEREST & JENNING SERIES 5000 MODULAR BED
- K854839 — CYTOMEGELISA M TEST KIT
- K854851 — WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
- K854852 — WELLCOGEN BACTERIAL ANTIGEN KIT
- K854854 — SYSTEMS OF SIGHT LOW VISION EYEWARE
- K854867 — EVEREST & JENNINGS TRADITION-STANDARD BED L109684&
- K854873 — INTRAOCULAR PRESSURE REDUCER
- K854879 — SUNGLASSES
- K854937 — CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM
- K854949 — MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
- K854983 — OPTRONICS CONTRAST ACUITY TESTER
- K854994 — BARTELL SMALL INCISION LENS GLIDE
- K855018 — DURAHESIVE WAFER WITH FLANGE
- K855224 — ACROMED NESTED BONE PLATE
- K855251 — MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS
- K860001 — BARRAQUER-KRUMEICH REFRACTIVE SET
- K860201 — PARENTERAL ADMINISTRATION SET
- K854252 — TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER
- K854077 — MIX EVAC II
- K852525 — SATALEC PIEZOTEC
- K852648 — STARPORT MODEL H3300AA
- K852862 — CORNEO-GAGE TWO
- K853885 — MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA
- K854151 — HOMECARE CLINICS INFRAHEAT #230
- K854594 — PHOENIX U.V.A. SUNTAN BEDS
- K854633 — JACKSON RARE EARTH MAGNETIC ATTACHMENT
- K854707 — SUNTAINNING BOOTH
- K854855 — PROOF ALGINATE IMPRESSION MATERIAL
- K854878 — H40 BASE METAL ALLOY
- K854882 — PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT
- K854932 — ECUMOL ULTRAVIOLET FACE TANNING UNITS
- K854940 — TIPS AND PADS, CANE,CRUTCH AND WALKER
- K854957 — AUSTENAL DENTAL COMPOSITE RESIN
- K855005 — FIBER MESH
- K855030 — CHAMPY BONE PLATES & BONE SCREWS
- K855063 — UNIVERSAL PATIENT CHAIR UNI 2000X
- K855069 — SPIROMETER TS-400 SLZ 7547
- K855070 — SPIROMETER MODEL TS-200 SLZ 7541
- K860117 — KRYPTOSOL (SUN LAMP)
- K860193 — PORTALCAST
- K860203 — TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR
- K860254 — HEALTHDYNE'S EVENT RECORDER SYSTEM
- K854328 — MEDEX X-RAY TABLE
- K854509 — TRAVELPAK MODEL AC-102
- K854615 — MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
- K854675 — DSL ANDROSTENEDIONE RIA (DSL #4200)
- K854805 — ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM
- K854952 — CIRRUS NEBULIZER-DELUXE KIT
- K854958 — HCG RIA TEST SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.