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
65209–65232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 2005
SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS
K052042 · IYN
Sonoscape Company Limited
Radiology · 12d
Cleared Aug 09, 2005
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
K052053 · DIF
Bio-Rad
Toxicology · 11d
Cleared Aug 09, 2005
DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K052113 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 5d
Cleared Aug 08, 2005
MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005
K050655 · HRS
Kapp Surgical Instrument, Inc.
Orthopedic · 147d
Cleared Aug 08, 2005
MONDEAL CONTOUR HO SYSTEM
K050657 · HRS
Kapp Surgical Instrument, Inc.
Orthopedic · 147d
Cleared Aug 08, 2005
CRP DIAGNOSTIC ASSAY
K050836 · DCK
Sentinel Ch. Srl
Chemistry · 129d
Cleared Aug 08, 2005
DIRECT LDL CHOLESTEROL, MODEL L530-60H
K051121 · MRR
Teco Diagnostics
Chemistry · 98d
Cleared Aug 08, 2005
VASCULAR SOLUTIONS PRONTO SHORT EXTRACTION CATHETER
K051193 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 90d
Cleared Aug 08, 2005
IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100...
K051199 · GKZ
Sysmex America, Inc.
Hematology · 90d
Cleared Aug 08, 2005
HEMOGLOBIN A1C REAGENT SET
K051200 · LCP
Teco Diagnostics
Toxicology · 90d
Cleared Aug 08, 2005
SLIVASURE
K051409 · LED
Scandinavian Formulas, Inc.
Pathology · 69d
Cleared Aug 08, 2005
ESTELITE FLOW QUICK
K051808 · EBF
Tokuyama Dental Corporation
Dental · 34d
Cleared Aug 08, 2005
DIVER C.E. CATHETER
K051917 · QEZ
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 24d
Cleared Aug 08, 2005
CLEVER CHECK TD-3215/DR. T TD-3216 BLOOD GLUCOSE AND BLOOD PRESSURE...
K051936 · NBW
Taidoc Technology Corporation
Chemistry · 21d
Cleared Aug 05, 2005
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
K040627 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 514d
Cleared Aug 05, 2005
PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
K043388 · FTM
Pegasus Biologics, Inc.
General & Plastic Surgery · 239d
Cleared Aug 05, 2005
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM
K043547 · KWA
Biomet, Inc.
Orthopedic · 225d
Cleared Aug 05, 2005
METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P,...
K051042 · LIT
Angiometrx, Inc.
Cardiovascular · 102d
Cleared Aug 05, 2005
VERIFYNOW-P2Y12 ASSAY
K051231 · JOZ
Accumetrics, Inc.
Hematology · 84d
Cleared Aug 05, 2005
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
K051322 · BTL
Smiths Medical International , Ltd.
Anesthesiology · 77d
Cleared Aug 05, 2005
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
K051385 · KWI
Biomet, Inc.
Orthopedic · 70d
Cleared Aug 05, 2005
UGYTEX SUAL KNIT MESH
K051503 · OTP
Sofradim Production
Obstetrics & Gynecology · 59d
Cleared Aug 05, 2005
TRICOT BLOOD PRESSURE CUFF
K051539 · DXQ
Ya Horng Electronic Co., Ltd.
Cardiovascular · 56d
Cleared Aug 05, 2005
AVL HINGE KNEE SYSTEM
K051570 · KRO
Biomet, Inc.
Orthopedic · 52d