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
68569–68592 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 23, 2004
MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
K041727 · OBJ
Boston Scientific Scimed, Inc.
Cardiovascular · 28d
Cleared Jul 23, 2004
PTS PANELS CHOL+GLU TEST PANEL
K041750 · NBW
Polymer Technology Systems, Inc.
Chemistry · 24d
Cleared Jul 23, 2004
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE
K041790 · MHX
Datex-Ohmeda
Cardiovascular · 21d
Cleared Jul 23, 2004
GE LOGIQ 7 ULTRASOUND BT04
K041813 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 17d
Cleared Jul 23, 2004
NORIAN SRS FAST SET PUTTY
K041842 · MQV
Synthes (Usa)
Orthopedic · 15d
Cleared Jul 23, 2004
TRIO MONITOR
K041907 · MWI
Datascope Corp.
Cardiovascular · 8d
Cleared Jul 23, 2004
M2376A DEVICELINK SYSTEM
K041942 · MWI
Phillips Medical Systems
Cardiovascular · 4d
Cleared Jul 22, 2004
PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
K040565 · GXD
Physician Industries, Inc.
Neurology · 141d
Cleared Jul 22, 2004
OPTISOURCE, MODEL 1032P
K040766 · KXK
International Brachytherapy S.A.
Radiology · 119d
Cleared Jul 22, 2004
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
K040923 · JLS
Ibl GmbH
Chemistry · 105d
Cleared Jul 22, 2004
PATXFER RT
K040931 · LLZ
Brainlab AG
Radiology · 104d
Cleared Jul 22, 2004
TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE
K040978 · MNW
Tanita Corp. of America
Gastroenterology & Urology · 98d
Cleared Jul 22, 2004
AMBU DISPOSABLE PRESSURE MANOMETER
K040991 · CAP
Ambu, Inc.
Anesthesiology · 97d
Cleared Jul 22, 2004
LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY
K041085 · JWH
Depuy, Inc.
Orthopedic · 87d
Cleared Jul 22, 2004
MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS
K041150 · LRG
Dade Behring, Inc.
Microbiology · 80d
Cleared Jul 22, 2004
KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES
K041151 · DQY
Kerberos Proximal Solutions, Inc.
Cardiovascular · 80d
Cleared Jul 22, 2004
3DSCOPE
K041213 · OXO
Direx Systems Corp.
Radiology · 73d
Cleared Jul 22, 2004
GETTIG UNIVERSAL VIAL ACCESS PIN
K041232 · LHI
Gettig Pharmaceutical Instrument Co.
General Hospital · 73d
Cleared Jul 22, 2004
PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES
K041345 · FOZ
Medix, Inc.
General Hospital · 63d
Cleared Jul 22, 2004
SAS INFLUENZA B TEST
K041439 · PSZ
Sa Scientific, Inc.
Microbiology · 51d
Cleared Jul 22, 2004
SAS INFLUENZA A TEST
K041441 · PSZ
Sa Scientific, Inc.
Microbiology · 51d
Cleared Jul 22, 2004
SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023
K041453 · DWQ
Smith & Nephew, Inc.
Cardiovascular · 51d
Cleared Jul 22, 2004
COOK SIDEARM CORE TISSUE BIOPSY DEVICE
K041544 · KNW
Urological, Inc.
Gastroenterology & Urology · 43d
Cleared Jul 22, 2004
PEEK CEMENT RESTRICTOR X-BOX
K041583 · JDK
Innovasis, Inc.
Orthopedic · 41d