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
78913–78936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K012347 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 23, 2001
MODIFICATION TO VASCULAR CLOSURE DEVICE
K012362 · GDW
Std Mfg., Inc.
General & Plastic Surgery · 29d
Cleared Aug 23, 2001
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374 · GBM
Astra Tech, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 23, 2001
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
K012538 · DWF
Medtronic Vascular
Cardiovascular · 16d
Cleared Aug 23, 2001
GE LOGIQ A100 MP, MODEL 2272413
K012560 · IYO
General Electric Co.
Radiology · 15d
Cleared Aug 23, 2001
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE...
K012567 · MID
Corgenix, Inc.
Immunology · 14d
Cleared Aug 22, 2001
SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1
K001853 · FMI
Medtech Systems, Inc.
General Hospital · 429d
Cleared Aug 22, 2001
LIGHTLAS 532 PHOTOCOAGULATOR
K010372 · HQF
Lightmed Corp.
Ophthalmic · 196d
Cleared Aug 22, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010418 · LTT
Dade Behring, Inc.
Microbiology · 191d
Cleared Aug 22, 2001
CRYOPLAN SYSTEM
K011073 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 135d
Cleared Aug 22, 2001
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
K011604 · LNI
Ge Medical Systems, Inc.
Radiology · 90d
Cleared Aug 22, 2001
LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS
K011749 · LYY
Sempermed USA, Inc.
General Hospital · 83d
Cleared Aug 22, 2001
MONARCH INFLATION SYRINGE
K011811 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 72d
Cleared Aug 22, 2001
BRIDGE FX
K011817 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 72d
Cleared Aug 22, 2001
RADIOGRAPHIC MARKERS
K011856 · NEU
Encore Orthopedics, Inc.
General & Plastic Surgery · 70d
Cleared Aug 22, 2001
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
K011941 · FRO
The Kendall Company
General & Plastic Surgery · 62d
Cleared Aug 22, 2001
ORTHO DEVELOPMENT ORION-I EMF SYSTEM
K012129 · GEI
Ortho Development Corp.
General & Plastic Surgery · 44d
Cleared Aug 22, 2001
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
K012224 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 67d
Cleared Aug 22, 2001
JEL-20
K012303 · EJS
J.F. Jelenko & Co., Inc.
Dental · 33d
Cleared Aug 22, 2001
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
K012305 · KWQ
Sulzer Spine-Tech
Orthopedic · 30d
Cleared Aug 22, 2001
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Aug 22, 2001
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES
K012533 · DQA
Osi Medical, Inc.
Anesthesiology · 16d
Cleared Aug 22, 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · DZE
Straumann USA
Dental · 5d
Cleared Aug 21, 2001
KSEA DION-GRACIA SET
K010785 · DXC
KARL STORZ Endoscopy-America, Inc.
Cardiovascular · 159d