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

Filters: Cleared only ×
175,820 results
145129–145152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 1986
AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-200
K861074 · LGF
Martin Medical
Orthopedic · 7d
Cleared Mar 28, 1986
AMERICAN ORTHOPAEDIC CAST CUTTER, MODEL 0295-202
K861075 · LGF
Martin Medical
Orthopedic · 7d
Cleared Mar 27, 1986
COMPUTER ASSISTED DIABETIC INTRUCTION
K854249 · NDC
Applied Biomedical Computations, Inc.
General Hospital · 156d
Cleared Mar 27, 1986
STERILE LASER RESISTANT SURGICAL FIELD DRAPE
K854266
Lasersafe, Inc.
General & Plastic Surgery · 155d
Cleared Mar 27, 1986
DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER
K854268 · GWQ
Del Mar Avionics
Neurology · 155d
Cleared Mar 27, 1986
MS-189 MUSCLE STIMULATOR
K854801 · IPF
Electro Med Supply, Inc.
Physical Medicine · 115d
Cleared Mar 27, 1986
ICOR CALARIC MEASUREMENT UNIT (CMU)
K854927 · BZL
Icor AB
Anesthesiology · 107d
Cleared Mar 27, 1986
THERMOTRON 918
K860082 · IOA
Medical Microwave Research Corp.
Physical Medicine · 78d
Cleared Mar 27, 1986
MODAC-XXXX INTENSIVE MONITORING OF EEG
K860128 · GYE
Grass-Telefactor Product Group
Neurology · 72d
Cleared Mar 27, 1986
FORCE EVALUATION AND TESTING SYSTEM (FETS)
K860226 · LBB
Hoggan Health Industries, Inc.
Neurology · 64d
Cleared Mar 27, 1986
PULMANEX (TM)
K860693 · BTM
Life Design Systems, Inc.
Anesthesiology · 30d
Cleared Mar 27, 1986
ACE AIM - CPM HAND UNIT
K860714 · JFA
Buckman Co., Inc.
Physical Medicine · 29d
Cleared Mar 27, 1986
ROSENTHAL-FRENCH NEBULIZATION DOSIMETER
K860800 · CCQ
Laboratory For Applied Immunology, Inc.
Anesthesiology · 23d
Cleared Mar 27, 1986
HOYER ONE-TOUCH POWER LIFTER
K860837 · FSA
Ted Hoyer & Co., Inc.
General Hospital · 22d
Cleared Mar 27, 1986
HD CRYSTALINE SUCTION TIP
K860927 · JOL
Hospital Disposables, Inc.
General Hospital · 16d
Cleared Mar 27, 1986
STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG
K861056 · BZA
Intertech/Ohio
Anesthesiology · 8d
Cleared Mar 26, 1986
NORELCO ELECTRONIC DIGITAL BP METER HC3501
K854023 · DXQ
Philips Park
Cardiovascular · 177d
Cleared Mar 26, 1986
CRAIGWELL AID HA300
K854124 · ESD
Craigwell Electronics, Ltd.
Ear, Nose, Throat · 168d
Cleared Mar 26, 1986
OP II VISIBLE LIGHT CURING SYSTEM
K854696 · EBZ
Almore Intl., Inc.
Dental · 125d
Cleared Mar 26, 1986
SCI-PRO, PROPHYLAXIS PASTE
K854828 · EJR
Scientific Pharmaceuticals, Inc.
Dental · 113d
Cleared Mar 26, 1986
PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM
K855125 · DRT
Honeywell, Inc.
Cardiovascular · 93d
Cleared Mar 26, 1986
COFIELD SHOULDER SYSTEM
K855183 · KWS
Richards Medical Co., Inc.
Orthopedic · 90d
Cleared Mar 26, 1986
DENTAL FLOSS CARD
K860324 · JES
Washburn Laboratories
Dental · 56d
Cleared Mar 26, 1986
ACTISORB ACTIVATED CHARCOAL DRESSING
K860486 · FRO
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 44d