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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
166393–166416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1980
BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO
K801950 · KPX
B C Medical , Ltd.
Radiology · 49d
Cleared Oct 03, 1980
U.I. OCTOSON
K802030 · DXK
Ausonics Pty , Ltd.
Cardiovascular · 43d
Cleared Oct 03, 1980
NEWBOURNS INFANT VENTILATOR
K802051 · CBK
Bourns Medical Systems, Inc.
Anesthesiology · 39d
Cleared Oct 03, 1980
SPEMBLY 9000 & 9300
K802063 · GZJ
Spembly Medical , Ltd.
Neurology · 38d
Cleared Oct 03, 1980
BABYBIRD 2 VENTILATOR
K802087 · CBK
Bird Products Corp.
Anesthesiology · 31d
Cleared Oct 03, 1980
EGS #300 BATTERY OPER. PORTA. MUSCLE STI
K802107 · IPF
Electro-Med Health Industries, Inc.
Physical Medicine · 30d
Cleared Oct 03, 1980
ANESTHESIA GAS MACHINE
K802116 · BZC
Puritan Bennett Corp.
Anesthesiology · 29d
Cleared Oct 03, 1980
BEAR 2 ADULT VOL. VENTILATOR
K802118 · CBK
Bourns Medical Systems, Inc.
Anesthesiology · 29d
Cleared Oct 03, 1980
CM-700A AUTO-INFLATE CONTROL MODULE
K802203 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 22d
Cleared Oct 03, 1980
CT-1600 DIGITAL PULSE RATE MONITOR
K802204 · DRT
Industrial & Biomedical Sensors Corp.
Cardiovascular · 22d
Cleared Oct 03, 1980
ECG/RESPIRATION STIMULATOR
K802205 · BZQ
Healthdyne, Inc.
Anesthesiology · 22d
Cleared Oct 03, 1980
CORROSION PROOF SNAP ECG CONNECT WIRES
K802236 · DSA
Custom Cardio Components
Cardiovascular · 18d
Cleared Oct 03, 1980
CORROSION PROOF DUAL PURPOSE ECG WIRES
K802237 · DSA
Custom Cardio Components
Cardiovascular · 18d
Cleared Oct 03, 1980
VESSEL RETRACTOR, #600732
K802244 · DXC
Bentley Laboratories, Inc.
Cardiovascular · 17d
Cleared Oct 03, 1980
HOT CYCLE, A CHEMICAL TYPE HOT PACK
K802252 · IMD
Signal West
Physical Medicine · 17d
Cleared Oct 03, 1980
PRESSURE GAUGE ACCESSORY KIT/DILATATION
K802261 · DWF
Stanco Medical, Inc.
Cardiovascular · 17d
Cleared Oct 03, 1980
PROTECTIVE BAR FOR THE MA-1VENTILATOR
K802270 · CBK
Eastern Anesthesia, Inc.
Anesthesiology · 16d
Cleared Oct 03, 1980
TELEMETRY TRANSMITTER, #TLT-3
K802273 · DRG
Bd Becton Dickinson Vacutainer...
Cardiovascular · 16d
Cleared Oct 03, 1980
SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC
K802281 · CCQ
Sherwood Medical Co.
Anesthesiology · 14d
Cleared Oct 03, 1980
OHIO THORACIC SUCTION REGULATOR
K802285 · KOP
Ohio Medical Products
Dental · 14d
Cleared Oct 03, 1980
MINGOGRAF EEG21
K802292 · GWQ
Siemens Corp.
Neurology · 14d
Cleared Oct 03, 1980
MINGOGRAF EEG10
K802296 · GWQ
Siemens Corp.
Neurology · 14d
Cleared Oct 03, 1980
PEDIATRIC OXYGEN OR AEROSOL MASKS,
K802323 · BYG
Airlife, Inc.
Anesthesiology · 10d
Cleared Oct 03, 1980
DISPOSABLE CONSTRAST DELIVERY SPIKE KIT
K802329 · FPA
Stanco Medical, Inc.
General Hospital · 10d