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

Filters: Cleared only ×
176,076 results
78817–78840 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2001
INTERCEPT-URETHRAL MICROCOIL
K011781 · MOS
Surgi-Vision, Inc.
Radiology · 85d
Cleared Aug 31, 2001
DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
K011873 · LNS
Dornier
Gastroenterology & Urology · 77d
Cleared Aug 31, 2001
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011912 · MBI
Axya Medical, Inc.
Orthopedic · 73d
Cleared Aug 31, 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162 · HRS
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
K012292 · CFN
The Binding Site, Ltd.
Immunology · 42d
Cleared Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
K012296 · CFN
The Binding Site, Ltd.
Immunology · 42d
Cleared Aug 31, 2001
COALESCENT SURGICAL U-CLIP
K012317 · FZP
Coalescent Surgical
General & Plastic Surgery · 39d
Cleared Aug 31, 2001
MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
K012476 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 31, 2001
AA-1 SYSTEM
K012530 · HJT
Neurovision, Inc.
Ophthalmic · 25d
Cleared Aug 31, 2001
EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)
K012663 · IZL
Sedecal USA, Inc.
Radiology · 18d
Cleared Aug 30, 2001
JET THERAPY
K002908 · ISA
Jet Therapy
Physical Medicine · 346d
Cleared Aug 30, 2001
SENSI-PREMA NEONATAL ECG ELECTRODES,...
K003804 · DRX
Niko Medical Products
Cardiovascular · 265d
Cleared Aug 30, 2001
EXEL I.V. ADMINISTRATION SET
K010404 · FPA
Exelint Intl. Co.
General Hospital · 199d
Cleared Aug 30, 2001
VECTORVISION CT/FLUORO
K010968 · HAW
Brainlab AG
Neurology · 150d
Cleared Aug 30, 2001
THE UNI-CLIP STAPLE
K011716 · JDR
New Deal, S.A.
Orthopedic · 87d
Cleared Aug 30, 2001
ATRICURE BIPOLAR COAGULATION SYSTEM
K011722 · GEI
AtriCure, Inc.
General & Plastic Surgery · 87d
Cleared Aug 30, 2001
SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000
K011729 · DTC
Dni Nevada, Inc.
Cardiovascular · 87d
Cleared Aug 30, 2001
HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR
K011745 · ITI
Transworld Mobility Distribution, LLC
Physical Medicine · 85d
Cleared Aug 30, 2001
PALOMAR LC 100 DIODE LASER
K011747 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 86d
Cleared Aug 30, 2001
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
K011769 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 84d
Cleared Aug 30, 2001
MICRO TARGETING DRIVE SYSTEM
K011775 · HAW
FHC, Inc.
Neurology · 84d
Cleared Aug 30, 2001
INSIGHT GENESIS
K011983 · HCC
Fasstech
Neurology · 65d
Cleared Aug 30, 2001
ILT SUPPORT CATHETER .014, MODEL C114LW1
K012169 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 49d
Cleared Aug 30, 2001
SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM
K012253 · IYO
Aloka Co., Ltd.
Radiology · 43d