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
144289–144312 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1986
ES 180-DCM MUSCLE STIMULATOR
K860619 · IPF
Promatek
Physical Medicine · 100d
Cleared May 30, 1986
ENHANCE
K861041 · LYC
Packaging Technologies, Inc.
Dental · 73d
Cleared May 30, 1986
CURAMED 402 DIATHERMY UNIT
K861247 · IMJ
Henley Intl.
Physical Medicine · 58d
Cleared May 30, 1986
CURAPULS 419 DIATHERMY UNIT
K861248 · IMJ
Henley Intl.
Physical Medicine · 58d
Cleared May 30, 1986
OHMEDA POSI-PULSE SUCTION UNIT
K861261 · GCX
Ohmeda Medical
General Hospital · 56d
Cleared May 30, 1986
STOCKERT-SHILEY AORTIC ROOT CANNULAE
K861310 · DWF
Shiley, Inc.
Cardiovascular · 52d
Cleared May 30, 1986
RMI POROUS VENT PLUG
K861322 · DWF
Research Medical, Inc.
Cardiovascular · 52d
Cleared May 30, 1986
NEUTRALON SURGICAL GLOVES
K861441 · KGO
Surgikos, Inc.
General Hospital · 43d
Cleared May 30, 1986
MODEL DT-102 DATA TELEPHONE TRANSMITTER
K861455 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 42d
Cleared May 30, 1986
SURGICAL PACKS, KITS AND TRAYS
K861530 · FSM
Medical Concepts Development, Inc.
General & Plastic Surgery · 36d
Cleared May 30, 1986
TYPE 6500 HEARING AID ANALYZER
K861571 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 32d
Cleared May 30, 1986
ACS WHOLEY HI-TORQUE GUIDE WIRE
K861765 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 23d
Cleared May 30, 1986
CABOT VIDEOSCOPE
K861859 · HRX
Cabot Medical Corp.
Orthopedic · 16d
Cleared May 30, 1986
CRANIO BLADES AND WIRE PASS DRILL
K861876 · GFA
New England Surgical Instrument Corp.
General & Plastic Surgery · 15d
Cleared May 30, 1986
BYRON WORD BARTHOLIAN GLAND CATHETER
K861877 · GBA
Byron Medical
General & Plastic Surgery · 15d
Cleared May 30, 1986
SURGICAL HEAD SUPPORT
K861915 · CCX
Treace Medical, Inc.
Anesthesiology · 11d
Cleared May 30, 1986
STERILE DISPOSABLE SUCTION TUBE CATHETER
K861923
Pilling Co.
Anesthesiology · 11d
Cleared May 30, 1986
PCI CUSTOM DESIGN SERIES
K861943 · IQC
Poston & Cole Intl.
Physical Medicine · 10d
Cleared May 30, 1986
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
K861971 · LXB
Xomed, Inc.
Ear, Nose, Throat · 9d
Cleared May 29, 1986
EASY EYES TM LENS CARRYING CASE
K860677 · HPX
Applied Laboratories, Inc.
Ophthalmic · 93d
Cleared May 29, 1986
CNS 4/8 AND CT 48.1 SOFTWARE
K860829 · GWS
Cns, Inc.
Neurology · 85d
Cleared May 29, 1986
STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III
K860906 · JJY
American Dade
Toxicology · 80d
Cleared May 29, 1986
PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
K861048 · GGP
Sigma Chemical Co.
Hematology · 71d
Cleared May 29, 1986
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
K861049 · GGP
Sigma Chemical Co.
Hematology · 71d