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
73321–73344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2003
SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
K030409 · FGE
Cordis Corp.
Gastroenterology & Urology · 31d
Cleared Mar 10, 2003
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
K030420 · JAK
GE Medical Systems
Radiology · 28d
Cleared Mar 10, 2003
AMERICAN CATHETER, MODEL W3
K030538 · EZD
Catheter, LLC
Gastroenterology & Urology · 18d
Cleared Mar 07, 2003
IM2001 PULSE OXIMETER
K012706 · DQA
Imagyn Medical Technologies, Inc.
Anesthesiology · 570d
Cleared Mar 07, 2003
PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
K022167 · CAC
Pall Corp.
Anesthesiology · 247d
Cleared Mar 07, 2003
TRUEZONE PEAK FLOW METER
K023097 · BZH
Monaghan Medical Corp.
Anesthesiology · 170d
Cleared Mar 07, 2003
XYLOS XCELL ANTIMICROBIAL DRESSING
K024054 · MGQ
Xylos Corporation
General & Plastic Surgery · 88d
Cleared Mar 07, 2003
PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00
K024061 · GEX
Peregrine Surgical , Ltd.
General & Plastic Surgery · 88d
Cleared Mar 07, 2003
REPROCESSED COMPRESSION SLEEVES
K024074 · JOW
Alliance Medical Corp.
Cardiovascular · 87d
Cleared Mar 07, 2003
NAUTICA MICRO CATHETER, MODEL 105-5094-153
K024122 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 81d
Cleared Mar 07, 2003
AIGIS-INLAY
K024139 · EJT
Sb Lucius, Inc.
Dental · 81d
Cleared Mar 07, 2003
AIGIS-PT
K024144 · EJT
Sb Lucius, Inc.
Dental · 81d
Cleared Mar 07, 2003
AIGIS-XO
K024145 · EJT
Sb Lucius, Inc.
Dental · 81d
Cleared Mar 07, 2003
VIATORR ENDOPROSTHESIS
K024178 · JCT
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 79d
Cleared Mar 07, 2003
AUDIOSCREENER OAE+ABR
K024205 · EWO
Everest Biomedical Instruments Co.
Ear, Nose, Throat · 77d
Cleared Mar 07, 2003
ATAC PAK ALBUMIN REAGENT
K030006 · CIX
Elan Diagnostics
Chemistry · 64d
Cleared Mar 07, 2003
ATAC PAK PHOSPHORUS REAGENT
K030015 · CEO
Elan Diagnostics
Chemistry · 64d
Cleared Mar 07, 2003
NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK...
K030164 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 50d
Cleared Mar 07, 2003
CAUTERY TIP CLEANER, MODEL-TC-100
K030339 · GEI
Aspen Surgical Products, Inc.
General & Plastic Surgery · 35d
Cleared Mar 07, 2003
MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
K030460 · PAG
Brennen Medical, Inc.
Gastroenterology & Urology · 23d
Cleared Mar 07, 2003
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000)
K030551 · GEI
Arthrocare Corp.
General & Plastic Surgery · 14d
Cleared Mar 06, 2003
SURGICAL PATIENT WARMER, MODEL PW820 JHU
K022609 · ILY
Fisher &Paykel Healthcare , Ltd.
Physical Medicine · 212d
Cleared Mar 06, 2003
SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511
K022855 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 191d
Cleared Mar 06, 2003
URS-1B (BLOOD TEST)
K023297 · JIO
Teco Diagnostics
Chemistry · 155d