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
156457–156480 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 1983
STEAM PAK MOIST HEAT
K832803 · IMA
Electro-Med Health Industries, Inc.
Physical Medicine · 33d
Cleared Sep 20, 1983
SESAM TABLE
K832804 · INQ
Electro-Med Health Industries, Inc.
Physical Medicine · 33d
Cleared Sep 20, 1983
SHILEY 3L CARDF PLUS
K832811 · DTP
Shiley, Inc.
Cardiovascular · 33d
Cleared Sep 19, 1983
CATHETER CARE TRAY
K832389 · KOD
Inmed Corp.
Gastroenterology & Urology · 62d
Cleared Sep 19, 1983
UROTRACK PLUS
K832526 · KNX
Vital Metrics, Inc.
Gastroenterology & Urology · 52d
Cleared Sep 16, 1983
AMBULATORY MARK XI DRUG INFUSION DEV-
K830657 · FRN
Windsor Medical, Inc.
General Hospital · 198d
Cleared Sep 16, 1983
EGS MODEL 100-2
K832370
Electro-Med Health Industries, Inc.
Dental · 60d
Cleared Sep 15, 1983
VENTILATOR #1
K830488 · CBK
Ohio Medical Products
Anesthesiology · 212d
Cleared Sep 15, 1983
MICRO-STRUCTURED SURFACE HIP PROSTHESIS
K831708
Osteonics Corp.
Orthopedic · 81d
Cleared Sep 15, 1983
INFUSE-A-PORT
K832788 · LJT
Infusaid Corp.
General Hospital · 27d
Cleared Sep 12, 1983
ACCU-RYNGE PUMP SP-250
K830389 · FRN
Delta Medical Industries
General Hospital · 214d
Cleared Sep 12, 1983
AUTOMATED 8400 BLOOD CELL SEPARATOR
K831004 · LKN
Intl. Business Machines
Gastroenterology & Urology · 167d
Cleared Sep 12, 1983
DENTALON
K831077 · EBG
Kulzer, Inc.
Dental · 161d
Cleared Sep 12, 1983
DENTACOLOR LIGHT CURING CROWN & BRIDGE
K831215 · EBF
Kulzer, Inc.
Dental · 151d
Cleared Sep 12, 1983
LARYNGOSCOPE ATTACHMENT PH2000
K831255 · EQN
Eder Instrument Co, Inc.
Ear, Nose, Throat · 147d
Cleared Sep 12, 1983
BOMED BIOCON
K831421 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 132d
Cleared Sep 12, 1983
BIOFLOW
K831422 · DSB
Bomed Medical Mfr., Ltd.
Cardiovascular · 132d
Cleared Sep 12, 1983
AIR SHIELDS AS-100 MONIORING SYS-AS105
K831430 · DRT
Narco Scientific
Cardiovascular · 132d
Cleared Sep 12, 1983
SINGLE USE SYRINGE #103 PERSONAL MEDIC
K831444 · FRN
Pacesetter Systems
General Hospital · 130d
Cleared Sep 12, 1983
INFUSION SETS #'S 124 & 142 PERSONAL
K831445 · FPA
Pacesetter Systems
General Hospital · 130d
Cleared Sep 12, 1983
DOWNS ADJUSTABLE FLOW GENERATOR
K831503 · BYE
Vital Signs, Inc.
Anesthesiology · 124d
Cleared Sep 12, 1983
BIO-TEK PERCENT OXYGEN MONITOR 74222
K831522 · CCL
Bio-Tek Instruments, Inc.
Anesthesiology · 123d
Cleared Sep 12, 1983
PUMPETTE AS8P-INFUSION PUMP
K831534 · FRN
Travenol Laboratories, S.A.
General Hospital · 123d
Cleared Sep 12, 1983
ANESTHESIA/RESPIRATORY DISCONNECT -
K831650 · BZQ
Plasmedics, Inc.
Anesthesiology · 112d