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
36697–36720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 25, 2014
MEDELA THOPAZ+
K141553 · BTA
Medela AG
General & Plastic Surgery · 75d
Cleared Aug 25, 2014
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS
K142036 · FPA
B.Braun Medical, Inc.
General Hospital · 28d
Cleared Aug 25, 2014
CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
K142044 · LCM
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 28d
Cleared Aug 22, 2014
LUBRIGYN CREAM
K132772 · NUC
Uniderm Farmaceutici Srl
Obstetrics & Gynecology · 351d
Cleared Aug 22, 2014
NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART...
K133592 · DZE
Neodent USA, Inc.
Dental · 273d
Cleared Aug 22, 2014
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
K133921 · ETD
Preceptis Medical
Ear, Nose, Throat · 242d
Cleared Aug 22, 2014
VYNTUS/ SENTRYSUITE PRODUCT LINE
K133925 · BZC
Carefusion Germany 234 GmbH
Anesthesiology · 242d
Cleared Aug 22, 2014
PERSONAL KINETIGRAPH (PKG) SYSTEM
K140086 · GYD
Gkc Manufacturing Pty, Ltd.
Neurology · 220d
Cleared Aug 22, 2014
EPX-4440HD DIGITAL VIDEO PROCESSOR
K140149 · PEA
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 212d
Cleared Aug 22, 2014
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS...
K140210 · NBW
Bionime Corporation
Chemistry · 206d
Cleared Aug 22, 2014
IKNEE DISTAL FEMORAL CUTTING GUIDE
K140689 · OLO
Evergreen Orthopedic Research Lab
Orthopedic · 156d
Cleared Aug 22, 2014
1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER,...
K140944 · MCW
Atheromed, Inc.
Cardiovascular · 130d
Cleared Aug 22, 2014
COMPACTCATH INTERMITTENT URINARY CATHETER
K140945 · EZD
Compactcath, Inc.
Gastroenterology & Urology · 130d
Cleared Aug 22, 2014
NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE
K140946 · MQV
Novabone Products, LLC
Orthopedic · 130d
Cleared Aug 22, 2014
CONSTELLATION VISION SYSTEM
K141065 · HQE
Alcon Research, Ltd.
Ophthalmic · 120d
Cleared Aug 22, 2014
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR
K141083 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 116d
Cleared Aug 22, 2014
VOYANT ELECTROSURGICAL GENERATOR, VOYANT 5MM LAPAROSCOPIC SEALER-DIVIDER DEVICE
K141288 · GEI
Applied Medical Resources
General & Plastic Surgery · 98d
Cleared Aug 22, 2014
MERCURY SPINAL SYSTEM
K141372 · NKB
Spinal Elements, Inc.
Orthopedic · 87d
Cleared Aug 22, 2014
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III...
K141446 · GWJ
Natus Medical Incorporated
Neurology · 81d
Cleared Aug 22, 2014
CVI42
K141480 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 79d
Cleared Aug 22, 2014
ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
K141509 · PGM
Medos Sarl
Orthopedic · 77d
Cleared Aug 22, 2014
MUSTANG BALLOON DIALATION CATHETER
K141597 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 70d
Cleared Aug 22, 2014
VAPRO INTERMITTENT CATHETER
K141642 · GBM
Hollister Incorporated
Gastroenterology & Urology · 64d
Cleared Aug 22, 2014
BREAST SPEEDER CX, GRID HOLDER CX
K142002 · MOS
Quality Electrodynamics, LLC
Radiology · 30d