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
54121–54144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 2009
CARDIOVIEW32 REVIEW MODULE
K083749 · LOS
Qrs Diagnostic, LLC
Cardiovascular · 83d
Cleared Mar 10, 2009
FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL...
K090395 · FLL
Taidoc Technology Corporation
General Hospital · 21d
Cleared Mar 10, 2009
NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
K090502 · FOZ
U.S. Safety Syringes Co., Inc.
General Hospital · 13d
Cleared Mar 10, 2009
ZQUIET MOUTHPIECE
K090503 · LRK
Sleeping Well, LLC
Dental · 13d
Cleared Mar 09, 2009
ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
K081081 · MKJ
Zoll Medical Corporation, World Wide...
Cardiovascular · 327d
Cleared Mar 09, 2009
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
K082478 · BZG
Welch Allyn, Inc.
Anesthesiology · 193d
Cleared Mar 09, 2009
PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION...
K082964 · LNH
Prism Clinical Imaging, Inc.
Radiology · 157d
Cleared CT Mar 09, 2009
N-600X WITH SPD, OXIMAX N-600X
K083325 · DQA
Covidien
Anesthesiology · 117d
Cleared Mar 09, 2009
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
K083339 · CIC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 117d
Cleared Mar 09, 2009
PATHFAST HSCRP
K083412 · DCN
Mitsubishi Kagaku Iatron
Chemistry · 111d
Cleared Mar 09, 2009
CARDIUS 3 X-ACT
K083649 · KPS
Digirad Corp.
Radiology · 90d
Cleared Mar 09, 2009
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX...
K083796 · EJI
Miltex, Inc.
Dental · 77d
Cleared Mar 09, 2009
CLEARVUE PRONE BREAST TREATMENT TABLE
K090349 · IYE
Orbital Therapy, LLC
Radiology · 26d
Cleared Mar 09, 2009
SILS STITCH ENDOSCOPIC SUTURING DEVICE
K090419 · OCW
Covidien Lp, Formerly Registered AS...
Gastroenterology & Urology · 19d
Cleared Mar 06, 2009
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
K081063 · NGZ
Trek Diagnostic Systems, Inc.
Microbiology · 326d
Cleared Mar 06, 2009
CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
K081330 · BTL
O-Two Medical Technologies, Inc.
Anesthesiology · 298d
Cleared Mar 06, 2009
SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
K082528 · DQD
Noble Anesthesia-Air, Inc.
Cardiovascular · 185d
Cleared Mar 06, 2009
EVOX ELECTRO DIAGNOSTIC DEVICE
K082614 · GWF
Laborie Medical Technologies, Inc.
Neurology · 178d
Cleared Mar 06, 2009
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER,...
K082924 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 156d
Cleared Mar 06, 2009
TC ENDO PORT
K083218 · GCJ
Transcardiac Therapeutics, Inc.
General & Plastic Surgery · 126d
Cleared Mar 06, 2009
DUKAL SURGICAL DRAPE
K083320 · KKX
Dukal Corp.
General Hospital · 114d
Cleared Mar 06, 2009
DENOVISMED DENTAL IMPLANT SYSTEMS
K083543 · DZE
Denovis Medical, LLC
Dental · 98d
Cleared Mar 06, 2009
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C
K083558 · LZO
Medacta International S.A.
Orthopedic · 94d
Cleared Mar 06, 2009
KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE
K083609 · MBI
Kfx Medical
Orthopedic · 88d