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
142537–142560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 27, 1986
MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA
K863883 · CCK
Salter Labs
Anesthesiology · 21d
Cleared Oct 27, 1986
THE MMG 5 IN 1 CONNECTOR
K863912 · BYX
Medical Marketing Group
Anesthesiology · 19d
Cleared Oct 27, 1986
MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH
K864042 · ITY
Absolute X-Ray Corp.
Radiology · 11d
Cleared Oct 24, 1986
SUNGLASSES (NON-PRESCRIPTION)
K860953 · HQY
Roseburg SA
Ophthalmic · 225d
Cleared Oct 24, 1986
MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG
K862408 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 121d
Cleared Oct 24, 1986
PENN 3-RING HANDLE
K862729 · FFL
Penn Medical Devices, Inc.
Gastroenterology & Urology · 98d
Cleared Oct 24, 1986
MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE
K862863 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 87d
Cleared Oct 24, 1986
MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY
K862864 · GEX
Directed Energy, Inc.
General & Plastic Surgery · 87d
Cleared Oct 24, 1986
FLEXIBLE VISUALIZATION CATHETER
K862872 · FEI
American Edwards Laboratories
Gastroenterology & Urology · 86d
Cleared Oct 24, 1986
PERFECT ONE
K862930 · EJH
North American Alloys, Inc.
Dental · 81d
Cleared Oct 24, 1986
ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT
K862969 · LJM
Biohytech International, Inc.
Immunology · 79d
Cleared Oct 24, 1986
4-WIRE (CARSON) STONE EXTRACTOR
K863081 · FFL
Cook Urological, Inc.
Gastroenterology & Urology · 73d
Cleared Oct 24, 1986
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET
K863120 · KOB
Cook Urological, Inc.
Gastroenterology & Urology · 71d
Cleared Oct 24, 1986
MODEL 1350 URODYNAMIC WAVEFORM PROCESSOR
K863167 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 67d
Cleared Oct 24, 1986
MODEL 1101M & 1151M UROLAB MICRO URODYNAMIC RECORD
K863168 · FAP
Life-Tech Intl., Inc.
Gastroenterology & Urology · 67d
Cleared Oct 24, 1986
ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY
K863183 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 66d
Cleared Oct 24, 1986
UNITRON MODEL UL21 HEARING AID
K863225 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 64d
Cleared Oct 24, 1986
DIRECT BILIRUBIN PROCEDURE
K863265 · CIG
Data Medical Associates, Inc.
Toxicology · 60d
Cleared Oct 24, 1986
VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS
K863386 · KOB
Angiomed U.S., Inc.
Gastroenterology & Urology · 51d
Cleared Oct 24, 1986
BLOOD SPECIMEN COLLECTION DEVICES
K863491 · JKA
Medelec Intl. Corp.
Chemistry · 46d
Cleared Oct 24, 1986
'TENSAID'
K863567 · GZJ
Electro Therapeutic Devices, Inc.
Neurology · 42d
Cleared Oct 24, 1986
'MYOSTIM EX'
K863568 · GZJ
Electro Therapeutic Devices, Inc.
Neurology · 42d
Cleared Oct 24, 1986
COATED SUTURE NEEDLE
K863595 · GAB
Sharpoint, Inc.
General & Plastic Surgery · 39d
Cleared Oct 24, 1986
ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)
K863617 · JGS
Hi Chem, Inc.
Chemistry · 38d