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
68977–69000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 07, 2004
FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
K040048 · FDA
Fujinon, Inc.
Gastroenterology & Urology · 147d
Cleared Jun 07, 2004
VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR...
K040333 · FXX
Valumax Intl., Inc.
General Hospital · 117d
Cleared Jun 07, 2004
VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2
K040638 · GEI
Vnus Medical Technologies, Inc.
General & Plastic Surgery · 89d
Cleared Jun 07, 2004
21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A)
K040695 · LLZ
Totoku Electric Co., Ltd.
Radiology · 82d
Cleared Jun 07, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
K040767 · LBS
Beckman Coulter, Inc.
Chemistry · 74d
Cleared Jun 07, 2004
ECAT HRRT
K040933 · KPS
Cti Pet Systems, Inc.
Radiology · 59d
Cleared Jun 07, 2004
IRRIGATION TUBING SET 2.2M AND 3.8M
K041124 · EBW
W&H Dentalwerk Burmoos
Dental · 39d
Cleared Jun 07, 2004
QUANTIX OR VESSEL STABILIZER DEVICE
K041180 · DPW
Cardiosonix, Ltd.
Cardiovascular · 32d
Cleared Jun 07, 2004
PASCO MIC AND MIC/ID PANELS
K041214 · JWY
Pasco Laboratories, Inc.
Microbiology · 28d
Cleared Jun 07, 2004
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 28d
Cleared Jun 07, 2004
FEMORAL HOOK
K041261 · MBI
Arthrotek, Inc.
Orthopedic · 27d
Cleared Jun 07, 2004
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
K041281 · DSP
Datascope Corp.
Cardiovascular · 25d
Cleared Jun 07, 2004
SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
K041319 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Jun 07, 2004
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K041385 · EAP
Schick Technologies, Inc.
Radiology · 13d
Cleared Jun 04, 2004
INVACARE 3G TARSYS
K033819 · ITI
Invacare Corp.
Physical Medicine · 178d
Cleared Jun 04, 2004
PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10
K033985 · FTM
Pm Devices, Inc.
General & Plastic Surgery · 164d
Cleared Jun 04, 2004
MODIFICATION TO UNITY NETWORK ID
K040559 · MWI
Ge Medical Systems Information...
Cardiovascular · 93d
Cleared Jun 04, 2004
INNERVUE DIAGNOSTIC SCOPE SYSTEM
K040604 · GCJ
Arthrotek, Inc.
General & Plastic Surgery · 88d
Cleared Jun 04, 2004
VERSA-DIAL HUMERAL HEAD
K040610 · KWS
Biomet Manufacturing, Inc.
Orthopedic · 88d
Cleared Jun 04, 2004
MODULAR RADIAL HEAD REPLACEMENT DEVICE
K040611 · KWI
Biomet, Inc.
Orthopedic · 88d
Cleared Jun 04, 2004
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
K040613 · MEH
Exactech, Inc.
Orthopedic · 87d
Cleared Jun 04, 2004
SENSILASE PAD 3000
K040654 · DPW
Optical Sensors, Inc.
Cardiovascular · 84d
Cleared Jun 04, 2004
BIODERM SCIENCES WOUND DRESSING
K040683 · FRO
Bioderm Sciences, Inc.
General & Plastic Surgery · 80d
Cleared Jun 04, 2004
LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)
K040699 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 79d