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
64369–64392 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 2005
CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
K051757 · CJY
Diagnostic Chemicals , Ltd.
Chemistry · 134d
Cleared Nov 10, 2005
NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P
K052186 · DQA
Nellcor Puritan Bennett, Inc.
Anesthesiology · 91d
Cleared Nov 10, 2005
SOLANAS POSTERIOR STABILIZATION SYSTEM
K052201 · KWP
Alphatec Spine, Inc.
Orthopedic · 90d
Cleared Nov 10, 2005
ANGIOJET XPEEDIOR 120 CATHETER
K052256 · QEZ
Possis Medical, Inc.
Cardiovascular · 84d
Cleared Nov 10, 2005
ACUSON CYPRESS ULTRASOUND SYSTEM
K052331 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Nov 10, 2005
NIPRO HYPODERMIC NEEDLE
K052474 · FMI
Nipro Medical Corp.
General Hospital · 62d
Cleared Nov 10, 2005
EXTERNAL FIXATION
K052605 · KTT
Gexfix USA, Inc.
Orthopedic · 50d
Cleared Nov 10, 2005
TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
K052636 · LYZ
Teh Loong Corp.
General Hospital · 45d
Cleared Nov 10, 2005
ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55...
K052703 · LPL
Alden Optical Labs., Inc.
Ophthalmic · 43d
Cleared Nov 10, 2005
STELLA CERVICAL PLATE
K052763 · KWQ
Scient'X
Orthopedic · 41d
Cleared Nov 10, 2005
WRISTOX MODEL 3100 PULSE OXIMETER
K052829 · DQA
Nonin Medical, Inc.
Anesthesiology · 36d
Cleared Nov 10, 2005
CG FUTURE ANNULOPLASTY BAND
K052860 · KRH
Medtronic Heart Valves
Cardiovascular · 30d
Cleared Nov 10, 2005
JOSTRA HLM TUBING SET
K053025 · DWE
Maquet Cardiopulmonary, AG
Cardiovascular · 14d
Cleared Nov 10, 2005
KOWA NONMYD 7, KOWA NONMYD A-D
K053026 · HKI
Kowa Co. , Ltd.
Ophthalmic · 14d
Cleared Nov 09, 2005
GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR
K050550 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 251d
Cleared Nov 09, 2005
AQUADEX SYSTEM
K050609 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 244d
Cleared Nov 09, 2005
PROCEDUR-10
K052075 · FMF
Avanca Medical Devices, Inc.
General Hospital · 100d
Cleared Nov 09, 2005
TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET
K052148 · JIT
Reference Diagnostics, Inc.
Chemistry · 93d
Cleared Nov 09, 2005
SMIT SLEEVE
K052228 · JAQ
Nucletron Corporation
Radiology · 85d
Cleared Nov 09, 2005
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
K052314 · HIB
Dynarex Corp.
Obstetrics & Gynecology · 76d
Cleared Nov 09, 2005
B. BRAUN MODIFIED BICARBONATE DIALYSATE
K052393 · KPO
B.Braun Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Nov 09, 2005
CLINI-LASE SYSTEM, MODELS CL-BASE, CL-2000, CL-1200, CL-500, CL-300, CL-275,...
K052647 · ILY
American Spine Center, Ltd.
Physical Medicine · 44d
Cleared Nov 09, 2005
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K052838 · GGM
Bio-Rad
Chemistry · 33d
Cleared Nov 09, 2005
PEDIATRIC FEEDING TUBE
K052903 · KNT
Promedic, Inc.
Gastroenterology & Urology · 26d