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
55849–55872 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 2008
REPROCESSED EXTERNAL FIXATION DEVICE
K081586 · KTT
Sterilmed, Inc.
Orthopedic · 74d
Cleared Aug 18, 2008
OVERSTITCH ENDOSCOPIC SUTURE SYSTEM
K081853 · OCW
Apollo Endosurgery, Inc.
General & Plastic Surgery · 49d
Cleared Aug 15, 2008
MASS CASUALTY VENTILATOR, MODEL MCV100
K080063 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 218d
Cleared Aug 15, 2008
INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105
K080136 · JOJ
Steritec Products, Inc.
General Hospital · 206d
Cleared Aug 15, 2008
TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX
K080189 · DXQ
Trimline Medical Products Corp.
Cardiovascular · 203d
Cleared Aug 15, 2008
MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
K080530 · GEX
Cutera, Inc.
General & Plastic Surgery · 171d
Cleared Aug 15, 2008
HIPLOC COMPRESSION HIP SCREW
K080685 · JDO
Biomet Manufacturing, Inc.
Orthopedic · 157d
Cleared Aug 15, 2008
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K081038 · KWQ
Medtronic Sofamor Danek
Orthopedic · 126d
Cleared Aug 15, 2008
RESCUE EXTERNAL IMPLANT SYSTEM
K081302 · DZE
Megagen Implant Co., Ltd.
Dental · 99d
Cleared Aug 15, 2008
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A...
K081365 · MXC
St Jude Medical
Cardiovascular · 92d
Cleared Aug 15, 2008
C-INSIGHT
K081672 · LLZ
Mazor Surgical Technologies , Ltd.
Radiology · 63d
Cleared Aug 15, 2008
VERISTA IMAGING ISOCAM II GAMMA CAMERA
K081757 · IYX
Verista Imaging, Inc.
Radiology · 56d
Cleared Aug 15, 2008
ANEROID SPHYGMOMANOMETER, MODEL KT-A01
K081951 · DXQ
Wenzhou Kindcare Import & Export Co.,...
Cardiovascular · 37d
Cleared Aug 15, 2008
MODIFICATION TO MERCI RETRIEVER
K082034 · NRY
Concentric Medical, Inc.
Neurology · 29d
Cleared Aug 15, 2008
HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
K082075 · DRE
Hansen Medical, Inc.
Cardiovascular · 23d
Cleared Aug 15, 2008
AP 34 MULTI-THERAPY INFUSION PUMP
K082182 · FRN
Q-Core, Ltd.
General Hospital · 14d
Cleared Aug 15, 2008
GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2
K082185 · IYO
Ge Medical Systems Ultrasound and...
Radiology · 14d
Cleared Aug 14, 2008
UNASSIGNED
K080544 · FPA
Medcomp
General Hospital · 169d
Cleared Aug 14, 2008
BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
K081213 · GKZ
Bd Biosciences
Hematology · 106d
Cleared Aug 14, 2008
FLOWCARE TLG REAGENT
K081526 · GKZ
Beckman Coulter, Inc.
Hematology · 73d
Cleared Aug 14, 2008
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K081535 · LYZ
Rich Mountain Medical Products, Inc.
General Hospital · 73d
Cleared Aug 14, 2008
MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K081944 · MCW
Cardio Systems, Inc.
Cardiovascular · 37d
Cleared Aug 14, 2008
WATCH-PAT 200S-2 (WP200S-2)
K081982 · MNR
Itamar Medical
Anesthesiology · 34d
Cleared Aug 13, 2008
TRAUSON BONE PLATE
K073432 · HRS
Trauson (Jiangsu) Medical Instrument...
Orthopedic · 251d