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
61777–61800 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2006
ZYOPTIX XP EPI SEPARATOR SYSTEM
K062465 · HNO
Bausch & Lomb, Inc.
Ophthalmic · 13d
Cleared Sep 05, 2006
AIRNERGY+STREAM
K052492 · ILY
Natural Energy Solutions AG
Physical Medicine · 358d
Cleared Sep 05, 2006
IMAX 9.5 STERILIZERS
K052532 · FLE
Dental X Srl
General Hospital · 355d
Cleared Sep 05, 2006
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031
K060734 · LKN
Fresenius Medical Care North America
Gastroenterology & Urology · 169d
Cleared Sep 05, 2006
PORTRAIT PSR3
K060948 · GEI
Rhytec Incorporated
General & Plastic Surgery · 152d
Cleared Sep 05, 2006
LAPDOC I
K061224 · HAW
Robodent GmbH
Neurology · 127d
Cleared Sep 05, 2006
PILOT POSTERIOR LUMBAR PLATING SYSTEM
K061364 · MNH
Life Spine
Orthopedic · 112d
Cleared Sep 05, 2006
PULSE OXIMETER, MODEL PM-50
K061442 · DQA
Shenzhen Mindray Bio-Medical...
Anesthesiology · 104d
Cleared Sep 05, 2006
MSD BIPOLAR FORCEPS
K061635 · GEI
Medtronic Sofamor Danek
General & Plastic Surgery · 85d
Cleared Sep 05, 2006
REPROCESSED EXTERNAL FIXATION DEVICE
K061759 · KTT
Ascent Healthcare Solutions
Orthopedic · 75d
Cleared Sep 05, 2006
MULTILINK SPRINT
K061781 · EMA
Ivoclar Vivadent, Inc.
Dental · 71d
Cleared Sep 05, 2006
INVACARE'S TWILIGHT II NASAL MASKS
K061874 · BZD
Invacare Corp.
Anesthesiology · 64d
Cleared Sep 05, 2006
CORONIS 3MP AND MDCG 3120-CB
K061924 · LLZ
Barcoview
Radiology · 60d
Cleared Sep 05, 2006
CORONIS COLOR 3MP AND MDCC 3120-DL
K061927 · LLZ
Barcoview
Radiology · 60d
Cleared Sep 05, 2006
CORONIS COLOR 2MP AND MDCC 2121
K061928 · LLZ
Barcoview
Radiology · 60d
Cleared Sep 05, 2006
MEDTRONIC EXPORT XT CATHETER
K061958 · QEZ
Medtronic Vascular
Cardiovascular · 56d
Cleared Sep 05, 2006
FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040
K061960 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 56d
Cleared Sep 05, 2006
LIFESOUND ESOPHAGEAL STETHOSCOPE
K062020 · BZT
Novamed, LLC
Anesthesiology · 50d
Cleared Sep 05, 2006
RB12 SUCTION RECTAL BIOPSY SYSTEM
K062159 · FCK
Aus Systems Pty , Ltd.
Gastroenterology & Urology · 39d
Cleared Sep 05, 2006
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11,...
K062281 · DZE
Zimmer Dental, Inc.
Dental · 29d
Cleared Sep 05, 2006
CERAMAX
K062504 · EIH
Alphadent Co., Ltd.
Dental · 8d
Cleared Sep 01, 2006
AXYAFLEX POLYESTER SUTURE
K060165 · GAT
Axya Medical, Inc.
General & Plastic Surgery · 221d
Cleared Sep 01, 2006
RETRO SILVER AND XPRESSO SILVER CHRONIC HEMODIALYSIS CATHETERS
K060288 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 207d
Cleared Sep 01, 2006
EXCEL BOND DC, MODEL 28-200100
K060882 · KLE
J. Morita USA, Inc.
Dental · 154d