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
55153–55176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 2008
MYRAY SKYVIEW
K081088 · MUH
Cefla S.C.
Radiology · 204d
Cleared Nov 06, 2008
OLYMPUS CHF TYPE V
K081456 · FBN
Olympus Medical Systems Corporation
Gastroenterology & Urology · 167d
Cleared Nov 06, 2008
OSV II
K081773 · JXG
Integra Neurosciences Implants S.A.
Neurology · 136d
Cleared Nov 06, 2008
ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
K081979 · MQV
Apatech , Ltd.
Orthopedic · 118d
Cleared Nov 06, 2008
DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
K082261 · KPR
Dxrad Solutions , Ltd.
Radiology · 90d
Cleared Nov 06, 2008
INFINITT CARDIOLOGY PACS
K082706 · LLZ
Infinitt Co., Ltd.
Radiology · 51d
Cleared Nov 06, 2008
HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL
K082987 · MOS
Invivo
Radiology · 30d
Cleared Nov 06, 2008
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM &...
K083033 · MQV
Orthovita, Inc.
Orthopedic · 27d
Cleared Nov 06, 2008
AGILIS NXT STEERABLE INTRODUCER
K083083 · DYB
St Jude Medical
Cardiovascular · 21d
Cleared Nov 05, 2008
COMPONENT NEUROMONITORING SYSTEM
K080217 · OMA
Moberg Research, Inc.
Neurology · 281d
Cleared Nov 05, 2008
BODY CONTROL SYSTEM FAMILY, BODY CONTROL DUO AND CT5
K081026 · NGX
Sport-Elec S.A.
Physical Medicine · 209d
Cleared Nov 05, 2008
MODIFICATION TO 4CIS VANE SPINE SYSTEM
K081145 · MNI
Solco Biomedical Co., Ltd.
Orthopedic · 197d
Cleared Nov 05, 2008
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
K081858 · HKI
Clarity Medical Systems
Ophthalmic · 127d
Cleared Nov 05, 2008
LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
K082101 · GEX
Sandstone Medical Technologies, LLC
General & Plastic Surgery · 103d
Cleared Nov 05, 2008
INDEPENDENCE SPACER
K082252 · OVD
Globus Medical, Inc.
Orthopedic · 89d
Cleared Nov 05, 2008
DARCO SMALL SCREW
K082320 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 84d
Cleared Nov 05, 2008
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
K082720 · EOQ
Olympus Medical Systems Corporation
Ear, Nose, Throat · 49d
Cleared Nov 05, 2008
ARTHROCARE ARTHROWANDS
K082980 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Nov 04, 2008
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT
K080294 · NAK
Astoria-Pacific, Inc.
Chemistry · 274d
Cleared Nov 04, 2008
DISCOVERY MR450
K083147 · LNH
Ge Medical Systems, LLC
Radiology · 11d
Cleared Nov 03, 2008
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
K082050 · LOL
DiaSorin, Inc.
Microbiology · 108d
Cleared Nov 03, 2008
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA...
K082078 · HRS
Zimmer, Inc.
Orthopedic · 103d
Cleared Nov 03, 2008
OSTEORAPTOR SUTURE ANCHOR
K082215 · JDR
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 89d
Cleared Nov 03, 2008
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER
K082646 · DQY
Usci Ireland
Cardiovascular · 53d