Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
144409–144432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1986
THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS
K861751 · KNN
Special Health Systems, Ltd.
Physical Medicine · 17d
Cleared May 23, 1986
KINESETHETIC SEATING SYSTEM/WHEELCHAIR
K861754 · KNN
Special Health Systems, Ltd.
Physical Medicine · 17d
Cleared May 23, 1986
SHS CUSHION/WHEELCHAIR
K861755 · KNN
Special Health Systems, Ltd.
Physical Medicine · 17d
Cleared May 23, 1986
MEDCARE SUTURE REMOVAL KIT
K861804
Medcomp Technologies, Inc.
General & Plastic Surgery · 14d
Cleared May 23, 1986
MEDCARE FORCEPS (THUMB, TISSUE)
K861805 · GEN
Medcomp Technologies, Inc.
General & Plastic Surgery · 14d
Cleared May 23, 1986
MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
K861806 · KDA
Medcomp Technologies, Inc.
General & Plastic Surgery · 14d
Cleared May 23, 1986
MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)
K861807 · HRQ
Medcomp Technologies, Inc.
General & Plastic Surgery · 14d
Cleared May 21, 1986
MICROSELECTION INTERSTITIAL REMOTE AFTERLOAD SYS
K853912 · JAQ
Nucletron-Oldelft Corp.
Radiology · 243d
Cleared May 21, 1986
THE M100 AIR/OXYGEN MIXER
K860373 · BZR
Newport Medical Instruments, Inc.
Anesthesiology · 107d
Cleared May 21, 1986
PTR MK II VENTILATOR
K860692 · BYT
Bear Medical Systems, Inc.
Anesthesiology · 85d
Cleared May 21, 1986
CHECK-UP PLAQUE FIGHTING GUM
K860843 · EJR
Minnetonka, Inc.
Dental · 76d
Cleared May 21, 1986
STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL
K860920 · DTR
Shiley, Inc.
Cardiovascular · 71d
Cleared May 21, 1986
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
K860980 · DSI
Spacelabs, Inc.
Cardiovascular · 71d
Cleared May 21, 1986
RMI CAROTID BY-PASS SHUNT
K860988 · DWF
Research Medical, Inc.
Cardiovascular · 65d
Cleared May 21, 1986
CARDIOPULMONARY CANNULA TUBING
K861096 · DWF
Bio Medicus, Inc.
Cardiovascular · 58d
Cleared May 21, 1986
HYPERBARIC PENETRATION EXTENSION SET
K861315 · CBF
Cutter Laboratories, Inc.
Anesthesiology · 43d
Cleared May 21, 1986
LAERDAL POCKET MASK
K861401 · CBP
Laerdal Medical Corp.
Anesthesiology · 36d
Cleared May 21, 1986
THERAPAX HT 150T
K861431 · JAD
Old Delft Corp. of America
Radiology · 35d
Cleared May 21, 1986
INFANT MONITOR
K861484 · BZQ
Healthdyne, Inc.
Anesthesiology · 29d
Cleared May 21, 1986
REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT
K861546 · EBF
Macrochem Corp.
Dental · 26d
Cleared May 21, 1986
ZEST MARK II (STANDARD & MINI)
K861561 · EGG
Zest Anchors, Inc.
Dental · 26d
Cleared May 21, 1986
CO2 LASER BRONCHOSCOPE SYSTEM
K861583 · LLO
Richard Wolf Medical Instruments Corp.
Anesthesiology · 22d
Cleared May 21, 1986
P-50 LIGHT CURED RESIN BONDED CERAMIC
K861740 · EBF
3M Company
Dental · 15d
Cleared May 21, 1986
LASER SKIN MARKER AND MASK WHITE LOTION
K861772 · FZZ
Pacific Poly Crafts
General & Plastic Surgery · 14d