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
40345–40368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 2013
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
K130549 · JAD
Carl Zeiss Meditec, Inc.
Radiology · 114d
Cleared Jun 26, 2013
MONITOR B40
K130584 · MHX
Ge Medical Systems China Co., Ltd.
Cardiovascular · 113d
Cleared Jun 26, 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
K131556 · JIT
Diazyme Laboratories
Chemistry · 28d
Cleared Jun 25, 2013
INFINI RADIOFREQUENCY SYSTEM
K121481 · GEI
Lutronic Corporation
General & Plastic Surgery · 403d
Cleared Jun 25, 2013
EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
K121628 · DXH
Epi Mobile Health Solutions (S) Pte,...
Cardiovascular · 386d
Cleared Jun 25, 2013
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON...
K122503 · NDN
Neuro Therm, Inc.
Orthopedic · 313d
Cleared Jun 25, 2013
DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0...
K130008 · HRS
I.T.S. GmbH
Orthopedic · 174d
Cleared Jun 25, 2013
FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE
K130487 · FMI
Pyng Medical Corp.
General Hospital · 120d
Cleared Jun 25, 2013
PRIMI AND SECONDI SUPPORT CATHETERS
K130850 · DQY
Thermopeutix, Inc.
Cardiovascular · 90d
Cleared Jun 25, 2013
EBA2 FEMORAL NAILING SYSTEM
K131005 · HSB
Citieffe S.R.L.
Orthopedic · 75d
Cleared Jun 25, 2013
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
K131181 · LCM
Omega Laboratories, Inc.
Toxicology · 61d
Cleared Jun 25, 2013
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
K131314 · MQB
Swissray Medical AG
Radiology · 49d
Cleared Jun 25, 2013
SHANGRING
K131373 · HFX
Wuhu Snnda Medical Treatment...
Obstetrics & Gynecology · 43d
Cleared Jun 25, 2013
TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION
K131489 · IYO
Tractus Corporation
Radiology · 33d
Cleared Jun 24, 2013
LAWMAX DILATOR
K123842 · DRE
Lifetech Scientific (Shenzhen) Co., Ltd.
Cardiovascular · 193d
Cleared Jun 24, 2013
STEALTH 360 ORBITAL PAD SYSTEM
K131092 · MCW
Cardio Systems, Inc.
Cardiovascular · 67d
Cleared Jun 24, 2013
CARDIOSLEEVE
K131287 · DQD
Rijuven Corp
Cardiovascular · 49d
Cleared Jun 23, 2013
PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
K131524 · OZW
Proteus Digital Health, Inc.
Gastroenterology & Urology · 26d
Cleared Jun 21, 2013
MFM-CMS CENTRAL MONITORING SYSTEM
K120727 · MHX
Edan Instruments, Inc.
Cardiovascular · 469d
Cleared Jun 21, 2013
TEZO TITANIUM CAGE FAMILY
K122957 · MAX
Ulrich GmbH & Co. KG
Orthopedic · 269d
Cleared Jun 21, 2013
ION MAGNUM GENIUS
K123158 · NGX
Ion Genius, Inc.
Physical Medicine · 255d
Cleared Jun 21, 2013
BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS)
K124038 · MWI
Bedside Clinical Systems, Inc.
Cardiovascular · 175d
Cleared Jun 21, 2013
TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
K130099 · LPH
Encore Medical, L.P.
Orthopedic · 157d
Cleared Jun 21, 2013
OAK RIDGE PRODUCTS SHARP CONTAINER
K130281 · MMK
Oak Ridge Products, LLC
General Hospital · 136d