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
38929–38952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2013
S-SCAN
K131996 · LNH
Esaote, S.P.A.
Radiology · 168d
Cleared Dec 13, 2013
TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS
K132015 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 165d
Cleared Dec 13, 2013
DURABLUE STERILIZATION WRAP
K132060 · FRG
Cardinal Health-Medical Products and...
General Hospital · 163d
Cleared Dec 13, 2013
BARD VENTRALEX HERNIA PATCH
K132441 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 129d
Cleared Dec 13, 2013
DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K132484 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 127d
Cleared Dec 13, 2013
CROSSCHECK PLATING SYSTEM
K132594 · HRS
Solana Surgical, LLC
Orthopedic · 116d
Cleared Dec 13, 2013
NORMED PELLEGRIN CALCANEUS STOP SCREW
K133035 · HWC
Normed Medizin-Technik GmbH
Orthopedic · 77d
Cleared Dec 12, 2013
AIDI DENTAL IMPLANT SYSTEM
K123861 · DZE
Aidi Biomedical, LLC
Dental · 363d
Cleared Dec 12, 2013
EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING
K130439 · DRN
Chongqing Psk Sci-Tech Development...
Cardiovascular · 294d
Cleared Dec 12, 2013
PLATINUM DRF IMAGING SYSTEM
K131766 · JAA
Apelem-Dms Group
Radiology · 178d
Cleared Dec 12, 2013
WTF SECURA SYRINGE AND NEEDLE
K132120 · FMF
Beijing Wantefu Medical Apparatus...
General Hospital · 156d
Cleared Dec 12, 2013
MEDCOMP GEN III POWER INJECTABLE PORT
K132177 · LJT
Medcomp ( Medical Components)
General Hospital · 150d
Cleared Dec 12, 2013
MYOPERFUSION
K132523 · JAK
Toshibamedical Systems Corporation
Radiology · 122d
Cleared Dec 12, 2013
SYNC-RX SYSTEM
K132558 · OWB
Volcano Corporation
Radiology · 119d
Cleared Dec 12, 2013
NEOGEN PSR SYSTEM
K132754 · GEI
Energist, Ltd.
General & Plastic Surgery · 100d
Cleared Dec 12, 2013
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK
K132803 · DRG
Medapps Inc., Dba Alere Connect
Cardiovascular · 97d
Cleared Dec 12, 2013
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132862 · NBW
Infopia Co, Ltd.
Chemistry · 91d
Cleared Dec 12, 2013
MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS...
K133074 · DSP
Datascope Corp.
Cardiovascular · 73d
Cleared Dec 12, 2013
INQWIRE DIAGNOSTIC GUIDE WIRE
K133230 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 52d
Cleared Dec 12, 2013
MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A
K133435 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 34d
Cleared Dec 11, 2013
AVINENT DENTAL IMPLANT SYSTEM
K121873 · DZE
Avinent Implant System S.L.
Dental · 532d
Cleared Dec 11, 2013
POLYSITE IMPLANTABLE INFUSION PORTS
K122834 · LJT
Perouse Medical
General Hospital · 450d
Cleared Dec 11, 2013
RETRIEVAL BAG
K123728 · GCJ
Flexbar Machine Corp.
General & Plastic Surgery · 372d
Cleared Dec 11, 2013
GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
K130317 · ODP
Genesys Spine
Orthopedic · 306d