FDA 510(k) clearances — page 825
clearances on record, most recent first.
Clearances — page 825
82,401–82,500 of 175,890- K000647 — DATEX-OHMEDA NETWORK AND CENTRAL
- K001242 — ISOLETTE INFANT INCUBATOR, MODEL C2HS
- K001265 — WELCH ALLYN INSTRUMENT INTERFACE MODULE
- K001275 — RETCAM II
- K001583 — ISLAND BIOSURGICAL BNS KIT #3
- K001729 — FOCUS
- K001747 — MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K001906 — ELECSYS INSULIN CALSET
- K002003 — HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING
- K993674 — POCKET ULTRASONIC PACHYMETER
- K994413 — BRAINSCAN
- K001401 — AMT THERAPEUTIC TABLE, MODEL 748AMT
- K001421 — ONTRAK TESTCUP 501, MODEL 3016633
- K001502 — AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
- K001516 — PASCO MIC AND MIC/ID PANELS
- K001524 — FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
- K001587 — 19 GA PLASTIC REINFORCED EPIDURAL CATHETER
- K001794 — EBI ANTERIOR CERVICAL PLATE SYSTEM
- K001804 — NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
- K001886 — APEX FIXATION PINS
- K001891 — MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C
- K993248 — AMPLATZER SIZING BALLOON
- K000837 — PUMA DENTAL CHAIR AND UNIT
- K000902 — KLINIDRAPE REINFORCED SURGICAL GOWNS
- K001194 — STERICHEK TOTAL CHLORINE REAGENT STRIPS
- K001217 — INSIDE VIEW
- K001231 — THE KALIX IMPLANT
- K001234 — BIOINSULATED SILICONE PUNCTUM PLUG
- K001255 — CD HORIZON SPINAL SYSTEM
- K001324 — SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)
- K001623 — SCULPTURE FLOW
- K001831 — NEEDLELESS TRANSFER DEVICE
- K001837 — NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
- K001861 — SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K001863 — SYNTHETIC POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
- K990144 — INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM
- K000124 — SENSATION -VACUUM ASSIST DEVICES
- K001214 — OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
- K001356 — ONTRAK TESTCUP PRO-5, MODEL 1986678
- K001625 — PRONOVA NONABSORBABLE SUTURE, USP
- K001812 — PEDIATRIC REFERENCE DATA
- K001902 — BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
- K994409 — INSTANT-VIEW OPIATES/MORPHINE URINE DIP STRIP TEST
- K000062 — CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
- K001063 — SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
- K001111 — PANORET, MODEL 1000A
- K001143 — RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
- K001156 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
- K001166 — ULTRA V THERAPEUTIC ULTRASOUND
- K001167 — OPI BAND
- K001228 — EXTERNAL FIXATION ANCHOR PIN
- K001251 — SNIPER, MODEL OR-3872XX SERIES
- K001320 — SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
- K001371 — CARDEON ASCENDING BALLOON CANNULA (ABC)
- K001494 — MODIFICATION TO PROMPT L-POP
- K001707 — DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
- K001778 — POROCOAT PRODIGY HIP PROSTHESIS
- K001822 — THE V-BAG
- K001910 — IM-9C MICROINJECTORS
- K001911 — IM-9A MICROINJECTORS
- K001912 — IM-9B MICROINJECTORS
- K994032 — FLUORO-TEX CARDIOVASCULAR PATCH
- K001129 — PROLONG, MODELS PL50, PL100, PL150
- K001334 — HITACHI AIRIS II
- K001596 — LIFERX
- K001756 — LUNAR REPORT GENERATOR II
- K001772 — LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
- K001789 — SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K001894 — MODIFICATION TO E-SCAN
- K993527 — LOOP ELECTRODE, BALL ELECTRODE
- K994265 — MEDISANA DIGITAL TENS
- K994266 — FDTENS 2010
- K000901 — KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
- K001110 — CRYSTAL-EEG MODEL 15
- K001117 — COMFORT STIM
- K001137 — AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
- K001165 — POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K001218 — CORRECT PLUS
- K001337 — DANIELS SHARPSMART REUSABLE SHARPS CONTAINER
- K001383 — SUPREMCAST V
- K001418 — ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
- K001430 — RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
- K001432 — DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE
- K001469 — R&D PROJECT DW269#25
- K001518 — GRADIA
- K001715 — POWDERED PATIENT EXAMINATION GLOVES, LATEX
- K001758 — DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)
- K001770 — BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A
- K001845 — MALLINCKRODT, GOODKNIGHT 418S
- K981089 — TISSOMAT AND SPRAY SET
- K983667 — IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
- K994404 — INSTANT-VIEW MORPHINE URINE CASSETTE TEST
- K000586 — BIOSCANNER TRIGLYCERIDES TEST STRIPS
- K001135 — 6F & 7F INTRODUCING CATHETERS (MODIFICATION)
- K001235 — OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
- K001848 — OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
- K993741 — EZ LDL CHOLESTEROL TEST SYSTEM
- K000860 — FUTURA SAFETY SYRINGE
- K000952 — HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
- K001059 — NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
Data sourced from openFDA. This site is unofficial and independent of the FDA.