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
41233–41256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2013
S4 SPINAL SYSTEM
K123939 · NKB
Aesculap Implant Systems, Inc.
Orthopedic · 82d
Cleared Mar 12, 2013
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
K130153 · MKJ
Philips Medical Systems
Cardiovascular · 49d
Cleared Mar 11, 2013
DISCOVERY TMAX MANUAL WHEELCHAIR
K113164 · IOR
Otto Bock Healthcare LP
Physical Medicine · 502d
Cleared Mar 11, 2013
CS-MAG II
K121825 · DPS
Biomagnetik-Park GmbH
Cardiovascular · 263d
Cleared Mar 11, 2013
GYNECOLOGY STERILIZATION TRAY
K121904 · KCT
Smith & Nephew Inc., Endoscopy Division
General Hospital · 255d
Cleared Mar 11, 2013
DX-D IMAGING PACKAGE
K122736 · MQB
Agfa Healthcare N.V.
Radiology · 173d
Cleared Mar 11, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
K123073 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 161d
Cleared Mar 11, 2013
GSO GS1 CANNULATED SCREW SYSTEM
K123487 · MNH
Gold Standard Orthopaedics, LLC
Orthopedic · 118d
Cleared Mar 11, 2013
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
K123614 · CAF
Trudell Medical Intl.
Anesthesiology · 108d
Cleared Mar 11, 2013
SILEX SACROILIAC JOINT FUSION SYSTEM
K123702 · OUR
X-Spine Systems, Inc.
Orthopedic · 98d
Cleared Mar 11, 2013
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
K123815 · JAQ
Varian Medical Systems, Inc.
Radiology · 89d
Cleared Mar 11, 2013
AAP RADIUS SET 2.5
K123875 · HRS
Aap Implantate AG
Orthopedic · 84d
Cleared Mar 11, 2013
PICCOLO LACTATE TEST SYSTEM
K130113 · KHP
Abaxis, Inc.
Chemistry · 54d
Cleared Mar 11, 2013
STEREOS WORKSTATION
K130395 · LLZ
Eos Imaging, Inc.
Radiology · 24d
Cleared Mar 08, 2013
REVOIS IMPLANT SYSTEM
K113042 · DZE
Riemser Arzneimittel AG
Dental · 513d
Cleared Mar 08, 2013
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
K113636 · CGA
Philosys Co., Ltd.
Chemistry · 455d
Cleared Mar 08, 2013
ORAVAN OSA
K121285 · LRK
New Jersey Snoring Solutions
Dental · 312d
Cleared Mar 08, 2013
QUIDEL MOLECULAR RSV + HMPV ASSAY
K122189 · OEM
Quidel Corp.
Microbiology · 227d
Cleared Mar 08, 2013
SYNOVIS COLLAGEN MATRIX (TBD)
K122306 · DXZ
Synovis Surgical Innovations
Cardiovascular · 219d
Cleared Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION...
K122468 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
K122469 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 08, 2013
IMAGE WORKS PANOURA
K122806 · MUH
Mic International
Radiology · 176d
Cleared Mar 08, 2013
ENDOSEE MODEL 8000 U-SCOPE
K123151 · HIH
Endosee Corp
Obstetrics & Gynecology · 150d
Cleared Mar 08, 2013
ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
K123212 · PDG
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 144d