FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
37129–37152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 2014
CT MIDLINE
K141151 · LJS
Medcomp (Medical Components, Inc.)
General Hospital · 64d
Cleared Jul 08, 2014
AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW
K141228 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 57d
Cleared Jul 08, 2014
WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
K141273 · MRZ
Welldoc, Inc.
General Hospital · 53d
Cleared Jul 08, 2014
ARTHREX FRACTURE PLATES AND SCREWS
K141478 · HRS
Arthrex, Inc.
Orthopedic · 34d
Cleared Jul 08, 2014
ARROW VPS STYLET PLUS AND CG+ ARROW PICC POWERED BY ARROW VPS STYLET PLUS
K141618 · OBJ
Arrow International, Inc (Subsidiary...
Cardiovascular · 21d
Cleared Jul 07, 2014
DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
K131601 · PGY
Qubyx Limited
Radiology · 399d
Cleared Jul 07, 2014
ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE,...
K132214 · NHA
Hager& Meisinger GmbH
Dental · 356d
Cleared Jul 07, 2014
GRAB 'N GO PLUS, GRAB 'N GO DIGITAL
K132778 · ECX
Praxair Healthcare Services
Anesthesiology · 305d
Cleared Jul 07, 2014
ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
K133299 · KDI
Fresenius Medical Care, North America...
Gastroenterology & Urology · 255d
Cleared Jul 07, 2014
SYNGO, CT DUAL ENERGY
K133648 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 222d
Cleared Jul 07, 2014
VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
K133784 · ODP
Zimmer Trabecular Metal Technology
Orthopedic · 207d
Cleared Jul 07, 2014
RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT: STANDARD, LONG AND XL
K140324 · MBI
Depuy Mitek, A Johnson and Johnson...
Orthopedic · 147d
Cleared Jul 07, 2014
PULSE OXIMETER
K140785 · DQA
Nonin Medical, Inc.
Anesthesiology · 98d
Cleared Jul 07, 2014
VECTORFLOW
K141051 · MSD
Arrow International, Inc.
Gastroenterology & Urology · 74d
Cleared Jul 07, 2014
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL...
K141432 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 38d
Cleared Jul 03, 2014
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
K131923 · GZI
Techlink International
Neurology · 372d
Cleared Jul 03, 2014
INFANT INCUBATOR
K132543 · FMZ
Bistos Co., Ltd.
General Hospital · 324d
Cleared Jul 03, 2014
Z5C
K132881 · DZE
Z-Systems AG
Dental · 293d
Cleared Jul 03, 2014
COBRA FUNDUS CAMERA
K132987 · HKI
C.S.O. S.R.L.
Ophthalmic · 282d
Cleared Jul 03, 2014
MICROPUNCTURE INTRODUCER SET
K133114 · DYB
Cook Incorporated
Cardiovascular · 276d
Cleared Jul 03, 2014
H&H EMERGENCY CRICOTHYROTOMY KIT
K133528 · JOH
H & H Medical Corporation
Anesthesiology · 230d
Cleared Jul 03, 2014
POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK
K133689 · LZA
Pt. Medisafe Technologies
General Hospital · 213d
Cleared Jul 03, 2014
ARTHROSURFACE KISSLOC KNOTLESS SUTURE SYSTEM
K133835 · HTN
Arthrosurface, Inc.
Orthopedic · 197d
Cleared Jul 03, 2014
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
K140141 · NBW
Ceragem Medisys, Inc.
Chemistry · 162d