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
68929–68952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2004
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230
K041383 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 20d
Cleared Jun 10, 2004
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
K032412 · KYB
Staar Surgical Co.
Ophthalmic · 310d
Cleared Jun 10, 2004
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED...
K033477 · MJC
Rochester Medical Corp.
Gastroenterology & Urology · 220d
Cleared Jun 10, 2004
JAX-TCP
K033552 · MQV
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Jun 10, 2004
BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80
K040657 · BTR
Vygon SA
Anesthesiology · 90d
Cleared Jun 10, 2004
AXIOM ARTIS U
K040675 · OWB
Siemens Medical Systems, Inc.
Radiology · 90d
Cleared Jun 10, 2004
EYE SPHERE IMPLANTS
K040689 · HPZ
Oculo Plastik, Inc.
Ophthalmic · 86d
Cleared Jun 10, 2004
21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)
K040697 · LLZ
Totoku Electric Co., Ltd.
Radiology · 85d
Cleared Jun 10, 2004
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND...
K040723 · BZH
Microlife Intellectual Property GmbH
Anesthesiology · 80d
Cleared Jun 10, 2004
R-TEST EVOLUTION 3
K040753 · MLO
Novacor
Cardiovascular · 78d
Cleared Jun 10, 2004
INCUBATOR CAPE
K040794 · MMP
Wrapped IN Comfort
General Hospital · 73d
Cleared Jun 10, 2004
DISPOSABLE OVERTUBE
K040836 · FED
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 10, 2004
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
K040882 · DAP
bioMerieux, Inc.
Hematology · 66d
Cleared Jun 10, 2004
ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000
K040926 · IYN
Hudson Diagnostic Imaging, LLC
Radiology · 63d
Cleared Jun 10, 2004
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
K040941 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 59d
Cleared Jun 10, 2004
CDS HEMATOLOGY CALIBRATOR (CDS CAL)
K041130 · KRZ
Clinical Diagnostic Solutions, Inc.
Hematology · 41d
Cleared Jun 10, 2004
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
K041234 · GKR
Hemocue, Inc.
Hematology · 31d
Cleared Jun 10, 2004
MODIFICATION TO TSRH SPINAL SYSTEM
K041282 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jun 10, 2004
MODIFICATION TO SMARTPIN
K041288 · HTY
Linvatec Biomaterials, Inc.
Orthopedic · 28d
Cleared Jun 10, 2004
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE...
K041296 · JXG
Codman & Shurtleff, Inc.
Neurology · 27d
Cleared Jun 10, 2004
NUMED PTS X SIZING BALLOON CATHETER
K041306 · MJN
NuMED, Inc.
Cardiovascular · 24d
Cleared Jun 10, 2004
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K041315 · IYE
Accuray, Inc.
Radiology · 24d
Cleared Jun 10, 2004
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER
K041418 · CAF
Cardinalhealth
Anesthesiology · 14d
Cleared Jun 10, 2004
SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K041455 · IYO
Sonoscape Company Limited
Radiology · 9d