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

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176,076 results
56713–56736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 2008
OLYMPUS XCHF TYPE B180Y1
K080586 · FBN
Olympus Medical Systems Corporation
Gastroenterology & Urology · 64d
Cleared May 06, 2008
AOS PROXIMAL HUMERAL PLATE
K080590 · KTW
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 64d
Cleared May 06, 2008
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
K080712 · MSY
Serim Research Corp.
Gastroenterology & Urology · 54d
Cleared May 06, 2008
SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100
K080764 · ODC
Max Endoscopy, Inc.
Gastroenterology & Urology · 49d
Cleared May 06, 2008
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
K080980 · MEH
Exactech, Inc.
Orthopedic · 29d
Cleared May 06, 2008
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
K081007 · KWA
Zimmer, Inc.
Orthopedic · 28d
Cleared May 05, 2008
FINGERTIP PULSE OXIMETER, MODEL CMS-50C
K073454 · DQA
Contec Medical System Co., Ltd.
Anesthesiology · 147d
Cleared May 05, 2008
CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL...
K080509 · OCL
Medtronic, Inc.
Cardiovascular · 70d
Cleared May 05, 2008
SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
K080605 · DSA
Curbell Electronics, Inc.
Cardiovascular · 62d
Cleared May 05, 2008
AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH...
K080898 · GDW
Tyco Healthcare Group LP
General & Plastic Surgery · 35d
Cleared May 05, 2008
ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
K081031 · FZP
Aesculap, Inc.
General & Plastic Surgery · 24d
Cleared May 05, 2008
BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
K081066 · IWG
Medi-Physics, Inc., Dba GE Healthcare
Radiology · 20d
Cleared May 05, 2008
SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL...
K081181 · GEX
Cynosure, Inc.
General & Plastic Surgery · 10d
Cleared May 04, 2008
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
K073377 · GKP
Instrumentation Laboratory CO
Hematology · 153d
Cleared May 02, 2008
MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER
K071642 · DQA
Mediaid, Inc.
Anesthesiology · 319d
Cleared May 02, 2008
ANT ANGIOGRAPHIC SYRINGES, MODEL(S)...
K072696 · DXT
Shenzhen Ant Hi-Tech Industrial Co.,...
Cardiovascular · 221d
Cleared May 02, 2008
POWDERED VINYL PATIENT EXAMINATION GLOVES
K073192 · LYZ
Shijiazhuang Prosperous Plastic Co.,...
General Hospital · 171d
Cleared May 02, 2008
CAIS STAPLE
K073281 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 163d
Cleared May 02, 2008
OEC 9900 ELITE
K073543 · OWB
Ge Oec Medical Systems
Radiology · 137d
Cleared May 02, 2008
OSFERION
K080065 · MQV
Olympus Terumo Biomaterials Corporation
Orthopedic · 113d
Cleared May 02, 2008
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
K080093 · GEI
Gyrus Acmi, Inc.
Obstetrics & Gynecology · 109d
Cleared May 02, 2008
ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
K080118 · GEX
Zeltiq Aesthetics
General & Plastic Surgery · 106d
Cleared May 02, 2008
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
K080158 · FZW
Lb Medical LLC
General & Plastic Surgery · 100d
Cleared May 02, 2008
AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
K080383 · FRO
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 80d