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
39433–39456 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 2013
AUDICOR CPAM WITH SDB (SINGLE SENSOR)
K130660 · MLO
Inovise Medical, Inc.
Cardiovascular · 213d
Cleared Oct 11, 2013
REVERSE MEDICAL MICROCATHETER
K130858 · DQY
Reverse Medical Corporation
Cardiovascular · 197d
Cleared Oct 11, 2013
ACUSON S2000 AND S3000
K130881 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 196d
Cleared Oct 11, 2013
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
K131023 · NFB
Medical Products, LLC
Anesthesiology · 182d
Cleared Oct 11, 2013
BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA
K131337 · JWH
Ortho Development Corp.
Orthopedic · 155d
Cleared Oct 11, 2013
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · LFR
Roche Diagnostics Operations, Inc.
Chemistry · 151d
Cleared Oct 11, 2013
MODIFIED CONCENTRIC MICROCATHETER
K131437 · DQO
Concentric Medical, Inc.
Cardiovascular · 144d
Cleared Oct 11, 2013
SEATTLE - PAP
K131502 · BZD
Seattle Childrens Hospital
Anesthesiology · 140d
Cleared Oct 11, 2013
KATANA ZIRCONIA
K131534 · EIH
Kuraray Noritake Dental, Inc.
Dental · 135d
Cleared Oct 11, 2013
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131677 · HSB
Ellipse Technologies, Inc.
Orthopedic · 123d
Cleared Oct 11, 2013
HIGH ENERGY LINEAR ACCELERATOR
K131807 · IYE
Varian Medical Systems, Inc.
Radiology · 114d
Cleared Oct 11, 2013
2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
K131908 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 107d
Cleared Oct 11, 2013
MTM(R) CLEAR ALIGNER
K132145 · NXC
Dentsply International, Inc.
Dental · 92d
Cleared Oct 11, 2013
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM...
K132161 · JWH
Exactech, Inc.
Orthopedic · 91d
Cleared Oct 11, 2013
IMDX C.DIFFICILE FOR ABBOTT M2000
K132235 · OZN
Intelligent Medical Devices, Inc.
Microbiology · 85d
Cleared Oct 11, 2013
PPA/BT-RB STETHOSCOPE
K132405 · DQD
Rnk Products, Inc.
Cardiovascular · 70d
Cleared Oct 11, 2013
PCP-USB STETHOSCOPE
K132560 · DQD
Rnk Products, Inc.
Cardiovascular · 57d
Cleared Oct 11, 2013
CLASSIC INTERMITTENT CATHETER
K132619 · EZD
Flexicare Medical, Ltd.
Gastroenterology & Urology · 51d
Cleared Oct 11, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132885 · LJS
Cook Incorporated
General Hospital · 25d
Cleared Oct 10, 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
K130728 · LZO
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared Oct 10, 2013
IDYS LIF CAGES
K131178 · MAX
Clariance
Orthopedic · 168d
Cleared Oct 10, 2013
T2 TIBIAL NAILING SYSTEM
K131365 · HSB
Stryker Trauma AG
Orthopedic · 150d
Cleared Oct 10, 2013
PEERSCOPE SYSTEM
K131422 · FDS
Endochoice, Inc.
Gastroenterology & Urology · 147d
Cleared Oct 10, 2013
POLARUS CONNECT
K131636 · LXT
Acumed, LLC
Orthopedic · 128d