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
64993–65016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2005
O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT
K042915 · NUC
O'My Products Incorporated
Obstetrics & Gynecology · 314d
Cleared Aug 31, 2005
MS 4/5 HEMATOLOGY ANALYZER
K050421 · GKZ
Melet Schloesing Laboratories USA
Hematology · 194d
Cleared Aug 31, 2005
TRIABSORB COMPOSITE SCREW
K050468 · HWC
Advanced Biomaterials
Orthopedic · 189d
Cleared Aug 31, 2005
REGENSIS PERICARDIAL PATCH
K051405 · DXZ
Cormatrix Cardiovascular, Inc.
Cardiovascular · 92d
Cleared Aug 31, 2005
LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021
K051473 · INI
Lerado China Limited
Physical Medicine · 89d
Cleared Aug 31, 2005
CANADY PLASMA PROBES
K052035 · GEI
Canady Technology, LLC
General & Plastic Surgery · 34d
Cleared Aug 31, 2005
OPTI-AMP DC-POWERED
K052060 · GWL
Intelligent Hearing Systems
Neurology · 33d
Cleared Aug 31, 2005
ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER
K052086 · PHX
Encore Medical, Inc.
Orthopedic · 29d
Cleared Aug 31, 2005
TSRH SPINAL SYSTEM
K052144 · NKB
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Aug 31, 2005
RELIEVA SINUS BALLOON INFLATION DEVICE
K052198 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 19d
Cleared Aug 31, 2005
DRYSTAR MODEL 5500
K052251 · LMC
Agfa Corporation
Radiology · 13d
Cleared Aug 30, 2005
PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K051301 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 103d
Cleared Aug 30, 2005
TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM
K051380 · MBH
Howmedica Osteonics Corp.
Orthopedic · 95d
Cleared Aug 30, 2005
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K051421 · NEU
Medical Device Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Aug 30, 2005
A-DEC SELF-CONTAINED WATER SYSTEM
K051657 · EIA
A-Dec, Inc.
Dental · 70d
Cleared Aug 30, 2005
CAREVENT CA AND DRA
K051889 · BTL
O-Two Medical Technologies, Inc.
Anesthesiology · 49d
Cleared Aug 30, 2005
ORS MODEL 6000 ENDOSCOPE HOLDER
K051979 · OCT
O.R. Solutions, Inc.
Gastroenterology & Urology · 40d
Cleared Aug 30, 2005
LUMENIS 1000 INTEGRATED SLIT LAMP
K052129 · GEX
Lumenis, Inc.
General & Plastic Surgery · 25d
Cleared Aug 29, 2005
POLYTECH PULMONARY FUNCTION FILTER
K042758 · BZG
Polytechnic Resources, Inc.
Anesthesiology · 329d
Cleared Aug 29, 2005
U1 HIP SYSTEM - BIPOLAR
K050269 · KWY
United Orthopedic Corp.
Orthopedic · 206d
Cleared Aug 29, 2005
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
K050558 · DTK
C.R. Bard, Inc.
Cardiovascular · 179d
Cleared Aug 29, 2005
PVC AND SILICONE MANUAL RESUSCITATORS
K051177 · BTM
David Medical Products Co.,Ltd
Anesthesiology · 115d
Cleared Aug 29, 2005
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
K051413 · HGX
Avent America, Inc.
Obstetrics & Gynecology · 90d
Cleared Aug 29, 2005
UROPLASTY RIGID ENDOSCOPIC NEEDLE
K051905 · FBK
Uroplasty, Inc.
Gastroenterology & Urology · 46d